Trial Outcomes & Findings for Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer (NCT NCT00005044)
NCT ID: NCT00005044
Last Updated: 2022-06-15
Results Overview
Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy. Death due to other causes is considered a competing risk. All others are censored. DSS is estimated using the cumulative incidence method. Ten-year rate is reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1579 participants
Primary outcome timeframe
From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Results posted on
2022-06-15
Participant Flow
Participant milestones
| Measure |
TAS x 8 Weeks
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
TAS x 28 Weeks
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
|---|---|---|
|
Overall Study
STARTED
|
790
|
789
|
|
Overall Study
COMPLETED
|
752
|
737
|
|
Overall Study
NOT COMPLETED
|
38
|
52
|
Reasons for withdrawal
| Measure |
TAS x 8 Weeks
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
TAS x 28 Weeks
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
37
|
46
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
No protocol treatment
|
0
|
1
|
Baseline Characteristics
Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
TAS x 8 Weeks
n=752 Participants
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
TAS x 28 Weeks
n=737 Participants
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
Total
n=1489 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
71 years
n=7 Participants
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
752 Participants
n=5 Participants
|
737 Participants
n=7 Participants
|
1489 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)Population: Eligible patients with follow-up data
Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy. Death due to other causes is considered a competing risk. All others are censored. DSS is estimated using the cumulative incidence method. Ten-year rate is reported.
Outcome measures
| Measure |
TAS x 8 Weeks
n=752 Participants
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
TAS x 28 Weeks
n=737 Participants
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
|---|---|---|
|
Disease-specific Survival (DSS) (10-year Rates Reported)
|
95 percentage of participants
Interval 93.0 to 97.0
|
96 percentage of participants
Interval 95.0 to 98.0
|
SECONDARY outcome
Timeframe: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)Population: Eligible patients with follow-up data
Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.
Outcome measures
| Measure |
TAS x 8 Weeks
n=752 Participants
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
TAS x 28 Weeks
n=737 Participants
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
|---|---|---|
|
Overall Survival (OS) (10-year Rates Reported)
|
66 percentage of participants
Interval 62.0 to 70.0
|
67 percentage of participants
Interval 63.0 to 71.0
|
SECONDARY outcome
Timeframe: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)Population: Eligible patients without follow-up data
Disease-free survival time is defined as time from randomization to the date of disease progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.
Outcome measures
| Measure |
TAS x 8 Weeks
n=752 Participants
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
TAS x 28 Weeks
n=737 Participants
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
|---|---|---|
|
Disease-free Survival (DFS) (10-year Rates Reported)
|
24 percentage of participants
Interval 20.0 to 27.0
|
23 percentage of participants
Interval 20.0 to 27.0
|
SECONDARY outcome
Timeframe: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)Population: Eligible patients with follow-up data
Time to distant metastasis measured from date of randomization to date of documented distant metastasis; competing risks are BF, LRP, and death without DM; all others are censored. Time to locoregional progression measured from date of randomization to date of documented local or regional progression; competing risks are BF \[protocol definition- first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy\], DM, and death without LRP; all others are censored. LRP and DM are estimated using the cumulative incidence method. Ten -year rates are reported.
Outcome measures
| Measure |
TAS x 8 Weeks
n=752 Participants
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
TAS x 28 Weeks
n=737 Participants
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
|---|---|---|
|
Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported)
Locoregional progression
|
6 percentage of participants
Interval 4.0 to 8.0
|
4 percentage of participants
Interval 3.0 to 6.0
|
|
Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported)
Distant metastasis
|
6 percentage of participants
Interval 4.0 to 8.0
|
6 percentage of participants
Interval 4.0 to 8.0
|
SECONDARY outcome
Timeframe: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)Population: Eligible patients with follow-up data
Protocol definition: Time to BF measured from date of randomization to first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. Phoenix definition: Time to BF measured from date of randomization to first of (1) the date of documented rise of 2 ng/ml above the post-treatment(RT end date) nadir or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. For both definitions BF is estimated using the cumulative incidence method. Ten year rates reported.
Outcome measures
| Measure |
TAS x 8 Weeks
n=752 Participants
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
TAS x 28 Weeks
n=737 Participants
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
|---|---|---|
|
Time to First Biochemical Failure (BF) (10-year Rates Reported)
Protocol definition
|
56 percentage of participants
Interval 52.0 to 59.0
|
59 percentage of participants
Interval 56.0 to 63.0
|
|
Time to First Biochemical Failure (BF) (10-year Rates Reported)
Phoenix definition
|
27 percentage of participants
Interval 23.0 to 30.0
|
27 percentage of participants
Interval 23.0 to 30.0
|
SECONDARY outcome
Timeframe: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)Population: Eligible patients with follow-up data
Time to SBF measured from date of randomization to the date of PSA increase of ≥1.0 ng/mL (from the nadir PSA after completion of protocol-specified therapy) after salvage androgen suppression was started; competing risks LRP, DM, and death without SBF; all others are censored. SBF is estimated using the cumulative incidence method. Ten-year rates are reported.
Outcome measures
| Measure |
TAS x 8 Weeks
n=752 Participants
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
TAS x 28 Weeks
n=737 Participants
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
|---|---|---|
|
Time to Second Biochemical Failure (SBF) (10-year Rates Reported)
|
10 percentage of participants
Interval 7.0 to 12.0
|
9 percentage of participants
Interval 7.0 to 12.0
|
SECONDARY outcome
Timeframe: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)Population: Eligible patients with adverse event data in corresponding time frame (during hormone therapy and \<=90 days from RT start; \> 90 days from RT start)
Acute drug therapy and radiation (\<= 90 days from start of RT) toxicity was graded using the Common Toxicity Criteria (CTC) v.2.0 criteria; late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring schema. Grade refers to the severity of the toxicity. The CTC v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild toxicity, Grade 2 Moderate toxicity, Grade 3 Severe toxicity, Grade 4 Life-threatening or disabling toxicity, Grade 5 Death related to toxicity. The highest grade acute and late toxicity was determined for each patient.
Outcome measures
| Measure |
TAS x 8 Weeks
n=747 Participants
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
TAS x 28 Weeks
n=735 Participants
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
|---|---|---|
|
Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)
Acute RT and Hormone Toxicity: Grade 1
|
30.8 percentage of participants
|
19.5 percentage of participants
|
|
Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)
Acute RT and Hormone Toxicity: Grade 2
|
41.6 percentage of participants
|
49.8 percentage of participants
|
|
Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)
Acute RT and Hormone Toxicity: Grade 3
|
16.1 percentage of participants
|
25.7 percentage of participants
|
|
Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)
Acute RT and Hormone Toxicity: Grade 4
|
0 percentage of participants
|
0.1 percentage of participants
|
|
Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)
Acute RT and Hormone Toxicity: Grade 5
|
0 percentage of participants
|
0 percentage of participants
|
|
Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)
Late RT Toxicity: Grade 1
|
34.0 percentage of participants
|
32.9 percentage of participants
|
|
Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)
Late RT Toxicity: Grade 2
|
20.5 percentage of participants
|
22.5 percentage of participants
|
|
Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)
Late RT Toxicity: Grade 3
|
9.7 percentage of participants
|
8.0 percentage of participants
|
|
Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)
Late RT Toxicity: Grade 4
|
0.1 percentage of participants
|
0.3 percentage of participants
|
|
Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)
Late RT Toxicity: Grade 5
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
TAS x 8 Weeks
Serious events: 121 serious events
Other events: 695 other events
Deaths: 0 deaths
TAS x 28 Weeks
Serious events: 109 serious events
Other events: 707 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAS x 8 Weeks
n=747 participants at risk
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
TAS x 28 Weeks
n=735 participants at risk
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
|---|---|---|
|
Cardiac disorders
Arrhythmia NOS
|
0.13%
1/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Supraventricular arrhythmia NOS
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhea NOS
|
1.6%
12/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
18/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastritis NOS
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Late RT Toxicity: Other GI: NOS
|
1.3%
10/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.41%
3/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Late RT Toxicity: Small/Large Intestine: NOS
|
1.2%
9/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.1%
8/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Proctitis NOS
|
0.13%
1/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting NOS
|
0.13%
1/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Late RT Toxicity: Other: NOS
|
3.2%
24/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
26/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain-other
|
0.13%
1/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Hepatobiliary disorders
Hepatic-Other
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection, Other
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation NOS
|
0.13%
1/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
15/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.54%
4/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
0.54%
4/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood bilirubin increased
|
0.13%
1/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Platelet count decreased
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.13%
1/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.13%
1/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia NOS
|
0.27%
2/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.41%
3/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoglycaemia NOS
|
0.13%
1/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.13%
1/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.13%
1/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache NOS
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.13%
1/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Syncope
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Dysuria
|
0.80%
6/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Late RT Toxicity: Bladder: NOS
|
4.4%
33/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.3%
24/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Renal/GU-Other
|
0.13%
1/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.27%
2/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary retention
|
0.13%
1/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Late RT Toxicity: Other GU: NOS
|
2.8%
21/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.4%
25/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea NOS
|
0.27%
2/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-other
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative NOS
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Late RT Toxicity: Skin: NOS
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypertension NOS
|
0.00%
0/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.14%
1/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Other adverse events
| Measure |
TAS x 8 Weeks
n=747 participants at risk
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
TAS x 28 Weeks
n=735 participants at risk
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.3%
25/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.7%
42/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhea NOS
|
31.9%
238/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
245/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Late RT Toxicity: Other GI: NOS
|
18.1%
135/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.6%
159/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Late RT Toxicity: Small/Large Intestine: NOS
|
26.0%
194/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
26.7%
196/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Proctitis NOS
|
23.2%
173/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.3%
164/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Late RT Toxicity: Other: NOS
|
15.1%
113/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.9%
124/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
21.3%
159/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
30.5%
224/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation NOS
|
13.8%
103/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.1%
89/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
12.3%
92/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.1%
104/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood bilirubin increased
|
4.0%
30/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.6%
41/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Libido decreased
|
2.3%
17/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.9%
51/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Dysuria
|
11.0%
82/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.6%
85/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Late RT Toxicity: Bladder: NOS
|
34.8%
260/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
36.7%
270/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary frequency
|
59.4%
444/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
62.0%
456/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
4.6%
34/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.6%
107/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Impotence
|
8.6%
64/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
18.0%
132/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Late RT Toxicity: Other GU: NOS
|
25.6%
191/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
26.4%
194/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Menopausal symptoms
|
61.3%
458/747
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
81.1%
596/735
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
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