Trial Outcomes & Findings for Hypofractionated Radiation Therapy or Conventional Radiation Therapy After Surgery in Treating Patients With Prostate Cancer (NCT NCT03274687)

NCT ID: NCT03274687

Last Updated: 2026-01-30

Results Overview

The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL. The urinary domain contains 12 items. Change from baseline is calculated by subtracting baseline from later score, with a positive change score indicating increased HRQOL.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 296 participants
• Primary outcome timeframe: Baseline (randomization), 2 years
• Results posted on: 2026-01-30

Participant Flow

Of 298 screened, 296 participants were randomized.

Participant milestones

Measure	Conventional Radiation Therapy Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy (ADT): Any luteinizing hormone-releasing hormone (LHRH) agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Overall Study STARTED	152	144
Overall Study Eligible	151	143
Overall Study Eligible With Adverse Event Data	148	141
Overall Study COMPLETED	151	143
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Conventional Radiation Therapy Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy (ADT): Any luteinizing hormone-releasing hormone (LHRH) agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Overall Study Protocol Violation	1	1

Baseline Characteristics

Hypofractionated Radiation Therapy or Conventional Radiation Therapy After Surgery in Treating Patients With Prostate Cancer

Baseline characteristics by cohort

Measure	Conventional Radiation Therapy n=151 Participants Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy n=143 Participants Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Total n=294 Participants Total of all reporting groups
Age, Customized ≤ 49 years	3 Participants n=35 Participants	2 Participants n=4328 Participants	5 Participants n=8687 Participants
Age, Customized 50 - 59 years	27 Participants n=35 Participants	31 Participants n=4328 Participants	58 Participants n=8687 Participants
Age, Customized 60 - 69 years	74 Participants n=35 Participants	83 Participants n=4328 Participants	157 Participants n=8687 Participants
Age, Customized ≥ 70 years	47 Participants n=35 Participants	27 Participants n=4328 Participants	74 Participants n=8687 Participants
Sex: Female, Male Female	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Sex: Female, Male Male	151 Participants n=35 Participants	143 Participants n=4328 Participants	294 Participants n=8687 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=35 Participants	5 Participants n=4328 Participants	12 Participants n=8687 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	142 Participants n=35 Participants	136 Participants n=4328 Participants	278 Participants n=8687 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=35 Participants	2 Participants n=4328 Participants	4 Participants n=8687 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Asian	2 Participants n=35 Participants	5 Participants n=4328 Participants	7 Participants n=8687 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Black or African American	22 Participants n=35 Participants	21 Participants n=4328 Participants	43 Participants n=8687 Participants
Race (NIH/OMB) White	125 Participants n=35 Participants	114 Participants n=4328 Participants	239 Participants n=8687 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=35 Participants	3 Participants n=4328 Participants	5 Participants n=8687 Participants
EPIC Group A Score Group (bowel domain score > 96, urinary domain score > 84)	56 Participants n=35 Participants	52 Participants n=4328 Participants	108 Participants n=8687 Participants
EPIC Group B Score Group (bowel domain score > 96, urinary domain score ≤ 84)	29 Participants n=35 Participants	32 Participants n=4328 Participants	61 Participants n=8687 Participants
EPIC Group C Score Group (bowel domain score ≤ 96, urinary domain score > 84)	31 Participants n=35 Participants	31 Participants n=4328 Participants	62 Participants n=8687 Participants
EPIC Group D Score Group (bowel domain score ≤ 96, urinary domain score ≤ 84)	35 Participants n=35 Participants	28 Participants n=4328 Participants	63 Participants n=8687 Participants
Prior androgen deprivation therapy (ADT) No	118 Participants n=35 Participants	110 Participants n=4328 Participants	228 Participants n=8687 Participants
Prior androgen deprivation therapy (ADT) Yes	33 Participants n=35 Participants	33 Participants n=4328 Participants	66 Participants n=8687 Participants
Prostate-specific antigen (PSA) ng/mL 0.0 - 0.5	135 Participants n=35 Participants	128 Participants n=4328 Participants	263 Participants n=8687 Participants
Prostate-specific antigen (PSA) ng/mL 0.6 - 1.0	10 Participants n=35 Participants	14 Participants n=4328 Participants	24 Participants n=8687 Participants
Prostate-specific antigen (PSA) ng/mL 1.1 - 1.5	3 Participants n=35 Participants	1 Participants n=4328 Participants	4 Participants n=8687 Participants
Prostate-specific antigen (PSA) ng/mL 1.6 - 2.0	3 Participants n=35 Participants	0 Participants n=4328 Participants	3 Participants n=8687 Participants
Gleason score 6	16 Participants n=35 Participants	7 Participants n=4328 Participants	23 Participants n=8687 Participants
Gleason score 7	105 Participants n=35 Participants	109 Participants n=4328 Participants	214 Participants n=8687 Participants
Gleason score 8	14 Participants n=35 Participants	15 Participants n=4328 Participants	29 Participants n=8687 Participants
Gleason score 9	15 Participants n=35 Participants	11 Participants n=4328 Participants	26 Participants n=8687 Participants
Gleason score 10	1 Participants n=35 Participants	1 Participants n=4328 Participants	2 Participants n=8687 Participants
T-Stage T2	76 Participants n=35 Participants	60 Participants n=4328 Participants	136 Participants n=8687 Participants
T-Stage T3	75 Participants n=35 Participants	83 Participants n=4328 Participants	158 Participants n=8687 Participants
N-Stage NX	30 Participants n=35 Participants	33 Participants n=4328 Participants	63 Participants n=8687 Participants
N-Stage N0	121 Participants n=35 Participants	110 Participants n=4328 Participants	231 Participants n=8687 Participants
Zubrod 0	128 Participants n=35 Participants	127 Participants n=4328 Participants	255 Participants n=8687 Participants
Zubrod 1	23 Participants n=35 Participants	16 Participants n=4328 Participants	39 Participants n=8687 Participants

PRIMARY outcome

Timeframe: Baseline (randomization), 2 years

Population: Eligible participants with baseline and two-year data

The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL. The urinary domain contains 12 items. Change from baseline is calculated by subtracting baseline from later score, with a positive change score indicating increased HRQOL.

Outcome measures

Measure	Conventional Radiation Therapy n=127 Participants Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy n=117 Participants Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years	-4.12 units on a scale Standard Deviation 14.72	-5.06 units on a scale Standard Deviation 15.16

PRIMARY outcome

Timeframe: Baseline, 2 years

Population: Eligible participants with baseline and two-year data

The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL. The bowel domain contains 14 items. Change from baseline is calculated by subtracting baseline from later score, with a positive change score indicating increased HRQOL.

Outcome measures

Measure	Conventional Radiation Therapy n=127 Participants Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy n=117 Participants Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Change in Bowel Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years	-1.42 units on a scale Standard Error 8.35	-4.21 units on a scale Standard Error 11.0

SECONDARY outcome

Timeframe: Baseline, end of RT, then 6 months,1 and 5 years from the start of RT (5 year time point has not yet been reached). RT dates depend on timing and duration of androgen deprivation therapy (ADT) (optional) and RT.

Population: Eligible participants with baseline data

The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL. The urinary domain contains 12 items. Change from baseline is calculated by subtracting baseline from later score, with a positive change score indicating increased HRQOL.

Outcome measures

Measure	Conventional Radiation Therapy n=151 Participants Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy n=143 Participants Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Change in Urinary Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of Radiation Therapy (RT), 6 Months, 1 and 5 Years End of RT	-4.34 units on a scale Standard Deviation 22.61	-7.90 units on a scale Standard Deviation 20.93
Change in Urinary Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of Radiation Therapy (RT), 6 Months, 1 and 5 Years 6 months	0.08 units on a scale Standard Deviation 20.26	-1.71 units on a scale Standard Deviation 18.55
Change in Urinary Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of Radiation Therapy (RT), 6 Months, 1 and 5 Years 1 year	-2.32 units on a scale Standard Deviation 22.63	-5.41 units on a scale Standard Deviation 21.15

SECONDARY outcome

Timeframe: Baseline, end of RT, then 6 months,1 and 5 years from the start of RT (5 year time point has not yet been reached). RT dates depend on timing and duration of ADT (optional) and RT.

Population: Eligible participants with baseline data

The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL. The bowel domain contains 14 items. Change from baseline is calculated by subtracting baseline from later score, with a positive change score indicating increased HRQOL.

Outcome measures

Measure	Conventional Radiation Therapy n=151 Participants Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy n=143 Participants Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Change in Bowel Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of RT, 6 Months, 1 and 5 Years End of RT	-6.83 units on a scale Standard Deviation 15.82	-14.96 units on a scale Standard Deviation 21.32
Change in Bowel Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of RT, 6 Months, 1 and 5 Years 6 months	-1.90 units on a scale Standard Deviation 13.63	-2.70 units on a scale Standard Deviation 13.98
Change in Bowel Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of RT, 6 Months, 1 and 5 Years 1 year	-2.67 units on a scale Standard Deviation 12.65	-3.11 units on a scale Standard Deviation 13.93

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years.

Population: Eligible participants

Biochemical failure was analyzed using two different definitions. The protocol definition of biochemical failure is a PSA measurement ≥ 0.4 ng/mL and rising (i.e. PSA ≥ 0.4 ng/mL followed by a value higher than the first by any amount) or followed by initiation of salvage hormones. The Phoenix definition of biochemical failure is a PSA measurement ≥ PSA nadir + 2 ng/mL where nadir is the lowest post-RT PSA value. Time to biochemical failure is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.

Outcome measures

Measure	Conventional Radiation Therapy n=151 Participants Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy n=143 Participants Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Percentage of Participants With Biochemical Failure Protocol definition	8.3 percentage of participants Interval 4.5 to 13.6	11.8 percentage of participants Interval 7.0 to 17.9
Percentage of Participants With Biochemical Failure Phoenix definition	3.5 percentage of participants Interval 1.3 to 7.4	8.0 percentage of participants Interval 4.2 to 13.3

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly.

Population: Eligible participants

Progression (failure) is defined as the first occurrence of biochemical failure, local failure, regional failure, distant failure, institution of new unplanned anticancer treatment, or death from prostate cancer. Time to progression is defined as time from randomization to the date of progression, last known follow-up (censored), or death without progression (competing risk). Progression rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.

Outcome measures

Measure	Conventional Radiation Therapy n=151 Participants Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy n=143 Participants Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Percentage of Participants With Progression	14.4 percentage of participants Interval 9.3 to 20.6	14.7 percentage of participants Interval 9.3 to 21.2

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly.

Population: Eligible participants

Local-regional failure is defined as local or regional failure. Local failure is defined as the development of a new biopsy-proven mass in the prostate bed. Regional failure is defined as radiographic evidence (CT or MRI) of lymphadenopathy (lymph node size ≥ 1.0 cm in the short axis) in a patient without the diagnosis of a hematologic/lymphomatous disorder associated with adenopathy. Time to local-regional failure is defined as time from randomization to the date of first local-regional failure, last known follow-up (censored), or death without local-regional (competing risk). Local-regional failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.

Outcome measures

Measure	Conventional Radiation Therapy n=151 Participants Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy n=143 Participants Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Percentage of Participants With Local-Regional Failure	0.7 percentage of participants Interval 0.1 to 3.5	0.8 percentage of participants Interval 0.1 to 3.8

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly.

Population: Eligible participants

Salvage therapy is defined as the initiation of new unplanned anticancer treatment. Time to salvage therapy initiation is defined as time from randomization to the date of first salvage therapy, last known follow-up (censored), or death without salvage therapy (competing risk). Salvage therapy rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of salvage initiation times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.

Outcome measures

Measure	Conventional Radiation Therapy n=151 Participants Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy n=143 Participants Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Percentage of Participants Receiving Salvage Therapy	7.5 percentage of participants Interval 3.9 to 12.5	5.8 percentage of participants Interval 2.7 to 10.6

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly.

Population: Eligible participants

Distant metastasis (failure) is defined as radiographic evidence of hematogenous spread evaluated by bone scan, CT, or MRI. Time to distant metastasis is defined as time from randomization to the date of first distant metastasis, last known follow-up (censored), or death without local recurrence (competing risk). Distant metastasis rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.

Outcome measures

Measure	Conventional Radiation Therapy n=151 Participants Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy n=143 Participants Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Percentage of Participants With Distant Metastasis	0.7 percentage of participants Interval 0.1 to 3.5	2.2 percentage of participants Interval 0.6 to 5.8

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly.

Population: Eligible participants

Cause of death was centrally reviewed. Count and percentage at time of analysis are reported.

Outcome measures

Measure	Conventional Radiation Therapy n=151 Participants Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy n=143 Participants Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Percentage of Participants Who Died From Prostate Cancer (Prostate Cancer Specific Mortality)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly.

Population: Eligible participants

Overall survival time is defined as time from registration/randomization to the date of death (failure) from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. 2-year rates are provided.

Outcome measures

Measure	Conventional Radiation Therapy n=151 Participants Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy n=143 Participants Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Percent of Participants Alive (Overall Survival)	98.6 percentage of participants Interval 97.0 to 100.0	98.5 percentage of participants Interval 96.8 to 100.0

SECONDARY outcome

Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly.

Population: Eligible with adverse event data

Common Terminology Criteria for Adverse Events (CTCAE) version 4 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. Counts of participants with any grade 3 or higher adverse event, any grade 3 or higher gastrointestinal adverse events, and any grade 3 or higher genitourinary adverse events are reported. Adverse events of any attribution are included.

Outcome measures

Measure	Conventional Radiation Therapy n=148 Participants Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy n=141 Participants Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Number of Participants With Grade 3+ Adverse Events All adverse events	25 Participants	20 Participants
Number of Participants With Grade 3+ Adverse Events Gastrointestinal Adverse Events	3 Participants	2 Participants
Number of Participants With Grade 3+ Adverse Events Genitourinary Adverse Events	6 Participants	10 Participants

Adverse Events

Conventional Radiation Therapy

Serious events: 1 serious events

Other events: 130 other events

Deaths: 0 deaths

Hypofractionated Radiation Therapy

Serious events: 8 serious events

Other events: 120 other events

Deaths: 0 deaths

Serious adverse events

Measure	Conventional Radiation Therapy n=148 participants at risk Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy n=141 participants at risk Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Cardiac disorders Myocardial infarction	0.00% 0/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	0.71% 1/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Gastrointestinal disorders Proctitis	0.00% 0/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	0.71% 1/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Immune system disorders Anaphylaxis	0.00% 0/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	0.71% 1/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.00% 0/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	0.71% 1/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Renal and urinary disorders Cystitis noninfective	0.00% 0/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	2.1% 3/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Renal and urinary disorders Hematuria	0.00% 0/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	0.71% 1/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Renal and urinary disorders Renal and urinary disorders - Other	0.00% 0/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	0.71% 1/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Renal and urinary disorders Renal calculi	0.68% 1/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	0.71% 1/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Renal and urinary disorders Urinary retention	0.00% 0/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	0.71% 1/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Reproductive system and breast disorders Pelvic pain	0.00% 0/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	0.71% 1/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.

Other adverse events

Measure	Conventional Radiation Therapy n=148 participants at risk Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.	Hypofractionated Radiation Therapy n=141 participants at risk Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Gastrointestinal disorders Abdominal pain	5.4% 8/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	3.5% 5/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Gastrointestinal disorders Constipation	11.5% 17/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	12.1% 17/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Gastrointestinal disorders Diarrhea	29.1% 43/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	37.6% 53/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Gastrointestinal disorders Gastrointestinal disorders - Other	8.8% 13/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	12.1% 17/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Gastrointestinal disorders Proctitis	5.4% 8/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	12.8% 18/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Gastrointestinal disorders Rectal hemorrhage	4.1% 6/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	12.8% 18/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
General disorders Fatigue	54.1% 80/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	44.0% 62/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Infections and infestations Urinary tract infection	5.4% 8/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	1.4% 2/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Musculoskeletal and connective tissue disorders Back pain	5.4% 8/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	5.0% 7/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Renal and urinary disorders Cystitis noninfective	8.1% 12/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	7.1% 10/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Renal and urinary disorders Hematuria	6.1% 9/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	14.2% 20/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Renal and urinary disorders Renal and urinary disorders - Other	24.3% 36/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	15.6% 22/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Renal and urinary disorders Urinary frequency	50.7% 75/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	51.8% 73/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Renal and urinary disorders Urinary incontinence	30.4% 45/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	34.0% 48/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Renal and urinary disorders Urinary retention	9.5% 14/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	6.4% 9/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Renal and urinary disorders Urinary tract pain	7.4% 11/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	10.6% 15/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Renal and urinary disorders Urinary urgency	29.1% 43/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	31.9% 45/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Reproductive system and breast disorders Erectile dysfunction	16.2% 24/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	12.8% 18/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Vascular disorders Hot flashes	25.0% 37/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	22.7% 32/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Vascular disorders Hypertension	5.4% 8/148 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.	7.8% 11/141 • Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.

Additional Information

Wendy Seiferheld

NRG Oncology

Phone: 215-574-3208

Email: seiferheldw@nrgoncology.org

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