Trial Outcomes & Findings for Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer (NCT NCT00567580)
NCT ID: NCT00567580
Last Updated: 2025-05-09
Results Overview
Progression is defined as the first occurrence of the following events: biochemical failure by the Phoenix definition (prostate-specific antigen \[PSA\] ≥ 2 ng/ml over the nadir PSA), clinical failure (local, regional or distant), or death from any cause. The initiation of second salvage therapy before progression was a protocol violation and resulted in censoring. Progression time is defined as time from randomization to the date of progression, second salvage therapy (censored), or last known follow-up (censored). Freedom from progression rates are estimated using the Kaplan-Meier method. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but results were reported early. See Limitations and Caveats section.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
1792 participants
Primary outcome timeframe
From randomization to five years.
Results posted on
2025-05-09
Participant Flow
Participant milestones
| Measure |
PBRT Alone
Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
|
PBRT + STAD
Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
PLNRT + PBRT + STAD
Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
|---|---|---|---|
|
Overall Study
STARTED
|
592
|
602
|
598
|
|
Overall Study
Eligible
|
564
|
578
|
574
|
|
Overall Study
Eligible, Started Study Treatment, and Have Adverse Event Data
|
547
|
563
|
563
|
|
Overall Study
COMPLETED
|
564
|
578
|
574
|
|
Overall Study
NOT COMPLETED
|
28
|
24
|
24
|
Reasons for withdrawal
| Measure |
PBRT Alone
Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
|
PBRT + STAD
Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
PLNRT + PBRT + STAD
Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
28
|
24
|
24
|
Baseline Characteristics
Eligible with lymphadenectomy details
Baseline characteristics by cohort
| Measure |
PBRT Alone
n=564 Participants
Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
|
PBRT + STAD
n=578 Participants
Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
PLNRT + PBRT + STAD
n=574 Participants
Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
Total
n=1716 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64 years
n=564 Participants
|
64 years
n=578 Participants
|
64 years
n=574 Participants
|
64 years
n=1716 Participants
|
|
Age, Customized
Age (years) · <=49
|
19 Participants
n=564 Participants
|
15 Participants
n=578 Participants
|
8 Participants
n=574 Participants
|
42 Participants
n=1716 Participants
|
|
Age, Customized
Age (years) · 50-59
|
118 Participants
n=564 Participants
|
137 Participants
n=578 Participants
|
138 Participants
n=574 Participants
|
393 Participants
n=1716 Participants
|
|
Age, Customized
Age (years) · 60-69
|
307 Participants
n=564 Participants
|
299 Participants
n=578 Participants
|
307 Participants
n=574 Participants
|
913 Participants
n=1716 Participants
|
|
Age, Customized
Age (years) · >=70
|
120 Participants
n=564 Participants
|
127 Participants
n=578 Participants
|
121 Participants
n=574 Participants
|
368 Participants
n=1716 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=564 Participants
|
0 Participants
n=578 Participants
|
0 Participants
n=574 Participants
|
0 Participants
n=1716 Participants
|
|
Sex: Female, Male
Male
|
564 Participants
n=564 Participants
|
578 Participants
n=578 Participants
|
574 Participants
n=574 Participants
|
1716 Participants
n=1716 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=564 Participants
|
23 Participants
n=578 Participants
|
30 Participants
n=574 Participants
|
74 Participants
n=1716 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
511 Participants
n=564 Participants
|
527 Participants
n=578 Participants
|
517 Participants
n=574 Participants
|
1555 Participants
n=1716 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=564 Participants
|
28 Participants
n=578 Participants
|
27 Participants
n=574 Participants
|
87 Participants
n=1716 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=564 Participants
|
0 Participants
n=578 Participants
|
5 Participants
n=574 Participants
|
5 Participants
n=1716 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=564 Participants
|
6 Participants
n=578 Participants
|
8 Participants
n=574 Participants
|
17 Participants
n=1716 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=564 Participants
|
4 Participants
n=578 Participants
|
0 Participants
n=574 Participants
|
5 Participants
n=1716 Participants
|
|
Race (NIH/OMB)
Black or African American
|
74 Participants
n=564 Participants
|
69 Participants
n=578 Participants
|
77 Participants
n=574 Participants
|
220 Participants
n=1716 Participants
|
|
Race (NIH/OMB)
White
|
464 Participants
n=564 Participants
|
482 Participants
n=578 Participants
|
474 Participants
n=574 Participants
|
1420 Participants
n=1716 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=564 Participants
|
0 Participants
n=578 Participants
|
0 Participants
n=574 Participants
|
3 Participants
n=1716 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=564 Participants
|
17 Participants
n=578 Participants
|
10 Participants
n=574 Participants
|
46 Participants
n=1716 Participants
|
|
Zubrod Performance Status
0
|
522 Participants
n=564 Participants
|
539 Participants
n=578 Participants
|
540 Participants
n=574 Participants
|
1601 Participants
n=1716 Participants
|
|
Zubrod Performance Status
1
|
42 Participants
n=564 Participants
|
39 Participants
n=578 Participants
|
34 Participants
n=574 Participants
|
115 Participants
n=1716 Participants
|
|
Pathologic Seminal Vesicle Involvement
No
|
482 Participants
n=564 Participants
|
494 Participants
n=578 Participants
|
488 Participants
n=574 Participants
|
1464 Participants
n=1716 Participants
|
|
Pathologic Seminal Vesicle Involvement
Yes
|
82 Participants
n=564 Participants
|
84 Participants
n=578 Participants
|
86 Participants
n=574 Participants
|
252 Participants
n=1716 Participants
|
|
Prostatectomy Tumor Stage
pT2
|
292 Participants
n=564 Participants
|
317 Participants
n=578 Participants
|
304 Participants
n=574 Participants
|
913 Participants
n=1716 Participants
|
|
Prostatectomy Tumor Stage
pT3 Extraprostatic extension NOS
|
13 Participants
n=564 Participants
|
15 Participants
n=578 Participants
|
18 Participants
n=574 Participants
|
46 Participants
n=1716 Participants
|
|
Prostatectomy Tumor Stage
pT3a Extraprostatic extension
|
177 Participants
n=564 Participants
|
162 Participants
n=578 Participants
|
166 Participants
n=574 Participants
|
505 Participants
n=1716 Participants
|
|
Prostatectomy Tumor Stage
pT3b Seminal vesicle invasion
|
82 Participants
n=564 Participants
|
84 Participants
n=578 Participants
|
86 Participants
n=574 Participants
|
252 Participants
n=1716 Participants
|
|
Gleason Score
4
|
0 Participants
n=564 Participants
|
1 Participants
n=578 Participants
|
1 Participants
n=574 Participants
|
2 Participants
n=1716 Participants
|
|
Gleason Score
5
|
3 Participants
n=564 Participants
|
1 Participants
n=578 Participants
|
5 Participants
n=574 Participants
|
9 Participants
n=1716 Participants
|
|
Gleason Score
6
|
80 Participants
n=564 Participants
|
85 Participants
n=578 Participants
|
89 Participants
n=574 Participants
|
254 Participants
n=1716 Participants
|
|
Gleason Score
7: 3+4
|
226 Participants
n=564 Participants
|
240 Participants
n=578 Participants
|
221 Participants
n=574 Participants
|
687 Participants
n=1716 Participants
|
|
Gleason Score
7:4+3
|
153 Participants
n=564 Participants
|
148 Participants
n=578 Participants
|
156 Participants
n=574 Participants
|
457 Participants
n=1716 Participants
|
|
Gleason Score
7: primary/secondary not indicated
|
9 Participants
n=564 Participants
|
5 Participants
n=578 Participants
|
3 Participants
n=574 Participants
|
17 Participants
n=1716 Participants
|
|
Gleason Score
8
|
57 Participants
n=564 Participants
|
60 Participants
n=578 Participants
|
57 Participants
n=574 Participants
|
174 Participants
n=1716 Participants
|
|
Gleason Score
9
|
36 Participants
n=564 Participants
|
38 Participants
n=578 Participants
|
42 Participants
n=574 Participants
|
116 Participants
n=1716 Participants
|
|
Prostatectomy Margins
Positive
|
288 Participants
n=564 Participants
|
289 Participants
n=578 Participants
|
284 Participants
n=574 Participants
|
861 Participants
n=1716 Participants
|
|
Prostatectomy Margins
Negative
|
267 Participants
n=564 Participants
|
284 Participants
n=578 Participants
|
287 Participants
n=574 Participants
|
838 Participants
n=1716 Participants
|
|
Prostatectomy Margins
Unknown
|
9 Participants
n=564 Participants
|
5 Participants
n=578 Participants
|
3 Participants
n=574 Participants
|
17 Participants
n=1716 Participants
|
|
Pelvic Lymphadenectomy
No
|
189 Participants
n=564 Participants
|
207 Participants
n=578 Participants
|
209 Participants
n=574 Participants
|
605 Participants
n=1716 Participants
|
|
Pelvic Lymphadenectomy
Yes
|
375 Participants
n=564 Participants
|
371 Participants
n=578 Participants
|
365 Participants
n=574 Participants
|
1111 Participants
n=1716 Participants
|
|
Number of Lymph Nodes Examined
|
5 lymph nodes
n=349 Participants • Eligible with lymphadenectomy details
|
6 lymph nodes
n=336 Participants • Eligible with lymphadenectomy details
|
5 lymph nodes
n=336 Participants • Eligible with lymphadenectomy details
|
6 lymph nodes
n=1021 Participants • Eligible with lymphadenectomy details
|
|
Pre-RT Entry PSA
|
0.32 ng/ml
n=564 Participants
|
0.40 ng/ml
n=578 Participants
|
0.32 ng/ml
n=574 Participants
|
0.35 ng/ml
n=1716 Participants
|
|
Pre-RT Entry PSA
>= 0.1 and <= 0.2 ng/ml
|
155 Participants
n=564 Participants
|
126 Participants
n=578 Participants
|
154 Participants
n=574 Participants
|
435 Participants
n=1716 Participants
|
|
Pre-RT Entry PSA
> 0.2 and <= 0.5 ng/ml
|
247 Participants
n=564 Participants
|
256 Participants
n=578 Participants
|
247 Participants
n=574 Participants
|
750 Participants
n=1716 Participants
|
|
Pre-RT Entry PSA
> 0.5 and <= 1.0 ng/ml
|
105 Participants
n=564 Participants
|
130 Participants
n=578 Participants
|
114 Participants
n=574 Participants
|
349 Participants
n=1716 Participants
|
|
Pre-RT Entry PSA
> 1.0 and < 2.0 ng/ml
|
57 Participants
n=564 Participants
|
66 Participants
n=578 Participants
|
59 Participants
n=574 Participants
|
182 Participants
n=1716 Participants
|
PRIMARY outcome
Timeframe: From randomization to five years.Population: Eligible participants
Progression is defined as the first occurrence of the following events: biochemical failure by the Phoenix definition (prostate-specific antigen \[PSA\] ≥ 2 ng/ml over the nadir PSA), clinical failure (local, regional or distant), or death from any cause. The initiation of second salvage therapy before progression was a protocol violation and resulted in censoring. Progression time is defined as time from randomization to the date of progression, second salvage therapy (censored), or last known follow-up (censored). Freedom from progression rates are estimated using the Kaplan-Meier method. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but results were reported early. See Limitations and Caveats section.
Outcome measures
| Measure |
PBRT Alone
n=564 Participants
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
|
PBRT + STAD
n=578 Participants
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
PLNRT + PBRT + STAD
n=574 Participants
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
|---|---|---|---|
|
Percentage of Participants Free From Progression (FFP) at 5 Years
|
70.3 percentage of participants
Interval 66.2 to 74.3
|
81.3 percentage of participants
Interval 77.9 to 84.6
|
87.4 percentage of participants
Interval 84.6 to 90.3
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.Population: Eligible participants
Secondary biochemical (failure) is defined as either of two occurrences: 1. For detectable post-baseline PSA values (≥ 0.1), the first occurrence of a PSA value that is both ≥ 0.4 and a second rise above nadir; 2.The start of second salvage therapy. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but results were reported early. See Limitations and Caveats section.
Outcome measures
| Measure |
PBRT Alone
n=564 Participants
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
|
PBRT + STAD
n=578 Participants
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
PLNRT + PBRT + STAD
n=574 Participants
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
|---|---|---|---|
|
Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure)
|
35.7 percentage of participants
Interval 31.6 to 39.9
|
22.3 percentage of participants
Interval 18.8 to 26.0
|
14.5 percentage of participants
Interval 11.6 to 17.7
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.Population: Eligible participants
Hormone-refractory disease (failure) is defined as three rises in PSA after the start of second salvage androgen deprivation therapy. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
Outcome measures
| Measure |
PBRT Alone
n=564 Participants
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
|
PBRT + STAD
n=578 Participants
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
PLNRT + PBRT + STAD
n=574 Participants
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
|---|---|---|---|
|
Percentage of Participants Free From Hormone-refractory Disease (Castrate-resistant Disease)
|
2.9 percentage of participants
Interval 1.7 to 4.7
|
2.4 percentage of participants
Interval 1.3 to 4.1
|
1.2 percentage of participants
Interval 0.5 to 2.5
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.Population: Eligible participants
Local failure is defined as first occurrence of local clinical progression. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
Outcome measures
| Measure |
PBRT Alone
n=564 Participants
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
|
PBRT + STAD
n=578 Participants
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
PLNRT + PBRT + STAD
n=574 Participants
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
|---|---|---|---|
|
Percentage of Participants With Local Failure
|
3.1 percentage of participants
Interval 1.8 to 4.9
|
1.2 percentage of participants
Interval 0.5 to 2.4
|
0.4 percentage of participants
Interval 0.1 to 1.3
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.Population: Eligible participants
Distant metastasis (failure) is defined as the occurrence of distant metastasis determined by imaging. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
Outcome measures
| Measure |
PBRT Alone
n=564 Participants
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
|
PBRT + STAD
n=578 Participants
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
PLNRT + PBRT + STAD
n=574 Participants
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
|---|---|---|---|
|
Percentage of Participants With Distant Metastasis
|
8.3 percentage of participants
Interval 6.1 to 11.0
|
5.9 percentage of participants
Interval 4.1 to 8.2
|
4.7 percentage of participants
Interval 3.1 to 6.8
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.Population: Eligible participants
Cause-specific mortality (failure) is defined as death due to prostate cancer or complications of protocol treatment (centrally reviewed), or death following disease progression (clinical or biochemical) in the absence of or after the initiation of any salvage therapy. \[Biochemical progression is indicated by any rise in PSA.\] Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
Outcome measures
| Measure |
PBRT Alone
n=564 Participants
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
|
PBRT + STAD
n=578 Participants
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
PLNRT + PBRT + STAD
n=574 Participants
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
|---|---|---|---|
|
Percentage of Participants Who Died Due to Prostate Cancer (Cause-specific Mortality)
|
2.7 percentage of participants
Interval 1.5 to 4.4
|
1.1 percentage of participants
Interval 0.4 to 2.3
|
0.8 percentage of participants
Interval 0.3 to 1.9
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.Population: Eligible participants
Survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. Pairwise comparisons of the overall distributions of failure times are reported in statistical analysis section, with five-year rates reported here. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
Outcome measures
| Measure |
PBRT Alone
n=564 Participants
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
|
PBRT + STAD
n=578 Participants
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
PLNRT + PBRT + STAD
n=574 Participants
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
|---|---|---|---|
|
Percentage of Participants Alive (Overall Mortality)
|
93.9 percentage of participants
Interval 91.8 to 96.0
|
96.1 percentage of participants
Interval 94.4 to 97.8
|
95.7 percentage of participants
Interval 94.0 to 97.4
|
SECONDARY outcome
Timeframe: From randomization to 90 days after completion of radiotherapy (approximately 7-8 weeks).Population: Eligible participants
Common Terminology Criteria for Adverse Events (version 3.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Pairwise comparisons of Arm 2 vs Arm 1 and Arm 3 vs. Arm 2 are reported in the statistical analysis.
Outcome measures
| Measure |
PBRT Alone
n=564 Participants
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
|
PBRT + STAD
n=578 Participants
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
PLNRT + PBRT + STAD
n=574 Participants
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
|---|---|---|---|
|
Percentage of Participants Experiencing Grade 2+ and 3+ Adverse Events ≤ 90 Days of the Completion of Radiotherapy (RT)
Grade 2+
|
18.8 percentage of participants
|
36.3 percentage of participants
|
43.6 percentage of participants
|
|
Percentage of Participants Experiencing Grade 2+ and 3+ Adverse Events ≤ 90 Days of the Completion of Radiotherapy (RT)
Grade 3+
|
4.4 percentage of participants
|
8.7 percentage of participants
|
12.2 percentage of participants
|
SECONDARY outcome
Timeframe: AE: from 91 days after completion of RT (approximately 7-8 weeks) to last follow-up. Vital status: from randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.Population: Eligible participants
Common Terminology Criteria for Adverse Events (version 3.0) grades adverse event severity from 1=mild to 5=death. Late adverse events (AE) are defined as occurring \> 90 days from the completion of RT. Failure time is defined as time from randomization to the date of first late grade 2 or grade 3 adverse event, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times between Arm 2 and Arm 1 and between Arm 3 and Arm 2, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored.
Outcome measures
| Measure |
PBRT Alone
n=564 Participants
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
|
PBRT + STAD
n=578 Participants
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
PLNRT + PBRT + STAD
n=574 Participants
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
|---|---|---|---|
|
Percentage of Participants Experiencing Late Grade 2+ and 3+ Adverse Events > 90 Days From the Completion of Radiotherapy (RT)
Grade 2+
|
52.8 percentage of participants
Interval 48.4 to 57.0
|
54.8 percentage of participants
Interval 50.4 to 58.9
|
58.6 percentage of participants
Interval 54.3 to 62.6
|
|
Percentage of Participants Experiencing Late Grade 2+ and 3+ Adverse Events > 90 Days From the Completion of Radiotherapy (RT)
Grade 3+
|
10.3 percentage of participants
Interval 7.8 to 13.2
|
11.4 percentage of participants
Interval 8.9 to 14.3
|
14.4 percentage of participants
Interval 11.6 to 17.5
|
SECONDARY outcome
Timeframe: From the 6th week of radiation therapy to 5 years post radiation therapy.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the 6th week of radiation therapy to 5 years post radiation therapy.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the 6th week of radiation therapy to 5 years post radiation therapy.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the 6th week of radiation therapy to 5 years post radiation therapy.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Date of randomization to timepoint of the respective primary or secondary endpoint.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the 6th week of radiation therapy to 5 years post radiation therapy.Outcome measures
Outcome data not reported
Adverse Events
PBRT Alone
Serious events: 18 serious events
Other events: 433 other events
Deaths: 48 deaths
PBRT + STADT
Serious events: 29 serious events
Other events: 492 other events
Deaths: 43 deaths
PLNRT + PBRT + STADT
Serious events: 23 serious events
Other events: 509 other events
Deaths: 43 deaths
Serious adverse events
| Measure |
PBRT Alone
n=547 participants at risk
Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
|
PBRT + STADT
n=563 participants at risk
Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STADT) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STADT starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
PLNRT + PBRT + STADT
n=563 participants at risk
Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STADT) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STADT starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Cardiac disorders
Myocardial ischemia
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.36%
2/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Eye disorders
Eye disorder
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.36%
2/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Diarrhea
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.36%
2/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Esophageal mucositis
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Esophagitis
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Ileus
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
General disorders
Fatigue
|
0.37%
2/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Infections and infestations
Bladder infection [with unknown ANC]
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Infections and infestations
Bone infection [with unknown ANC]
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Infections and infestations
Infection [other]
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Infections and infestations
Sepsis [with unknown ANC]
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Infections and infestations
Urinary tract infection [with unknown ANC]
|
0.55%
3/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Injury, poisoning and procedural complications
Intraoperative complications
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.36%
2/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.36%
2/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.36%
2/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.36%
2/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Bladder hemorrhage
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Bladder stenosis
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Cystitis
|
0.37%
2/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.71%
4/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.53%
3/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Renal hemorrhage
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Urethral obstruction
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.36%
2/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Urethral stricture
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Urinary frequency
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.53%
3/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.36%
2/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.73%
4/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.36%
2/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Urinary retention
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Urogenital disorder
|
0.91%
5/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.36%
2/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.18%
1/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Vascular disorders
Lymphocele
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.18%
1/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
0.00%
0/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
Other adverse events
| Measure |
PBRT Alone
n=547 participants at risk
Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
|
PBRT + STADT
n=563 participants at risk
Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STADT) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STADT starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
PLNRT + PBRT + STADT
n=563 participants at risk
Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STADT) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STADT starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
5.9%
32/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
13.0%
73/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
14.2%
80/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Constipation
|
9.9%
54/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
9.4%
53/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
10.5%
59/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Diarrhea
|
20.1%
110/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
22.6%
127/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
38.9%
219/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
6.6%
36/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
6.4%
36/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
5.9%
33/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.8%
26/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
5.2%
29/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
5.9%
33/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Proctitis
|
11.3%
62/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
9.8%
55/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
11.7%
66/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
7.9%
43/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
8.9%
50/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
8.5%
48/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
General disorders
Fatigue
|
27.1%
148/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
37.5%
211/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
38.5%
217/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
General disorders
Pain [other]
|
5.5%
30/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
5.5%
31/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
7.6%
43/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
8/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
6.2%
35/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
4.1%
23/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
11/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
6.2%
35/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
3.6%
20/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Investigations
Leukopenia
|
5.9%
32/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
5.2%
29/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
7.1%
40/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Investigations
Lymphopenia
|
5.1%
28/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
4.6%
26/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
8.9%
50/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.5%
30/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
6.2%
35/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
4.6%
26/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Psychiatric disorders
Libido decreased
|
6.4%
35/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
11.9%
67/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
14.7%
83/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Cystitis
|
12.6%
69/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
12.8%
72/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
12.6%
71/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
6.6%
36/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
5.2%
29/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
6.4%
36/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Urinary frequency
|
51.4%
281/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
59.1%
333/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
61.8%
348/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Urinary incontinence
|
43.3%
237/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
38.2%
215/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
42.5%
239/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Urinary retention
|
12.6%
69/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
12.3%
69/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
13.9%
78/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Renal and urinary disorders
Urogenital disorder
|
14.1%
77/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
11.4%
64/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
14.2%
80/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
28.3%
155/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
32.9%
185/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
35.9%
202/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
|
Vascular disorders
Hot flashes
|
6.6%
36/547 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
58.1%
327/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
57.7%
325/563 • Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Eligible participants who started study treatment and have adverse event data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER