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

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ClinicalTrials.gov Identifier: NCT03274687

Recruitment Status : Active, not recruiting

First Posted : September 7, 2017

Results First Posted : June 6, 2022

Last Update Posted : June 28, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

NRG Oncology

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Prostate Adenocarcinoma Stage I Prostate Adenocarcinoma Stage II Prostate Adenocarcinoma Stage III Prostate Adenocarcinoma
Interventions	Radiation: Hypofractionated radiation therapy Radiation: Conventional radiation therapy Drug: Optional androgen deprivation therapy
Enrollment	296

Participant Flow

Recruitment Details
Pre-assignment Details	Of 298 screened, 296 participants were randomized.


Arm/Group Title	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
Arm/Group Description	Conventional post-prostatectomy rad...	Hypofractionated post-prostatectomy...
Arm/Group Description	Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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 (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 post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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.
Period Title: Overall Study
Started	152	144
Eligible	151	143
Eligible With Adverse Event Data	148	141
Completed ^[1]	151	143
Not Completed	1	1
Reason Not Completed
Protocol Violation	1	1
[1] Participants contributing data to results are considered to have completed the study.

Baseline Characteristics

Arm/Group Title		Conventional Radiation Therapy	Hypofractionated Radiation Therapy	Total
Arm/Group Description		Conventional post-prostatectomy rad...	Hypofractionated post-prostatectomy...	Total of all reporting groups
Arm/Group Description		Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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.	Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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.	Total of all reporting groups
Overall Number of Baseline Participants		151	143	294
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Eligible participants
Age, Customized ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	151 participants	143 participants	294 participants
	≤ 49 years	3 2.0%	2 1.4%	5 1.7%
	50 - 59 years	27 17.9%	31 21.7%	58 19.7%
	60 - 69 years	74 49.0%	83 58.0%	157 53.4%
	≥ 70 years	47 31.1%	27 18.9%	74 25.2%
		[1] Measure Description: Years
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	151 participants	143 participants	294 participants
	Female	0 0.0%	0 0.0%	0 0.0%
	Male	151 100.0%	143 100.0%	294 100.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	151 participants	143 participants	294 participants
	Hispanic or Latino	7 4.6%	5 3.5%	12 4.1%
	Not Hispanic or Latino	142 94.0%	136 95.1%	278 94.6%
	Unknown or Not Reported	2 1.3%	2 1.4%	4 1.4%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	151 participants	143 participants	294 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	2 1.3%	5 3.5%	7 2.4%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	22 14.6%	21 14.7%	43 14.6%
	White	125 82.8%	114 79.7%	239 81.3%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	2 1.3%	3 2.1%	5 1.7%
EPIC Group ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	151 participants	143 participants	294 participants
	A Score Group (bowel domain score > 96, urinary domain score > 84)	56 37.1%	52 36.4%	108 36.7%
	B Score Group (bowel domain score > 96, urinary domain score ≤ 84)	29 19.2%	32 22.4%	61 20.7%
	C Score Group (bowel domain score ≤ 96, urinary domain score > 84)	31 20.5%	31 21.7%	62 21.1%
	D Score Group (bowel domain score ≤ 96, urinary domain score ≤ 84)	35 23.2%	28 19.6%	63 21.4%
		[1] Measure Description: 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. The bowel domain contains 14 items.
Prior androgen deprivation therapy (ADT) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	151 participants	143 participants	294 participants
	No	118 78.1%	110 76.9%	228 77.6%
	Yes	33 21.9%	33 23.1%	66 22.4%
Prostate-specific antigen (PSA) ng/mL ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	151 participants	143 participants	294 participants
	0.0 - 0.5	135 89.4%	128 89.5%	263 89.5%
	0.6 - 1.0	10 6.6%	14 9.8%	24 8.2%
	1.1 - 1.5	3 2.0%	1 0.7%	4 1.4%
	1.6 - 2.0	3 2.0%	0 0.0%	3 1.0%
		[1] Measure Description: Prostate-specific antigen (PSA) is a protein made by the prostate gland and found in the blood. PSA blood levels may be higher than normal in men who have prostate cancer, benign prostatic hyperplasia (BPH), or infection or inflammation of the prostate gland, and are often used to monitor patients who have been treated for prostate cancer to see if their cancer has recurred.
Gleason score ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	151 participants	143 participants	294 participants
	6	16 10.6%	7 4.9%	23 7.8%
	7	105 69.5%	109 76.2%	214 72.8%
	8	14 9.3%	15 10.5%	29 9.9%
	9	15 9.9%	11 7.7%	26 8.8%
	10	1 0.7%	1 0.7%	2 0.7%
		[1] Measure Description: Gleason score describes prostate cancer based on how abnormal the cancer cells in a biopsy sample look under a microscope. Cells are scored 1-5 with 1 indicating "low-grade" looking similar to normal cells and 5 indicating "high-grade" barely resembling normal cells due to mutation. A pathologist assigns a Gleason grade to the first and second most predominant patterns in the biopsy. The two grades are added together to calculate the Gleason score (between 2 and 10). Cancers with lower scores tend to be less aggressive, while cancers with higher scores end to be more aggressive.
T-Stage ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	151 participants	143 participants	294 participants
	T2	76 50.3%	60 42.0%	136 46.3%
	T3	75 49.7%	83 58.0%	158 53.7%
		[1] Measure Description: Tumor stage per the American Joint Committee on Cancer (AJCC) 7th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues.
N-Stage ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	151 participants	143 participants	294 participants
	NX	30 19.9%	33 23.1%	63 21.4%
	N0	121 80.1%	110 76.9%	231 78.6%
		[1] Measure Description: Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) refers to the number and/or extent of spread of lymph nodes that contain cancer. A higher number means the cancer is in more lymph nodes, farther away from the original tumor. N0 means lymph nodes aren't involved; NX means the lymph nodes could not be assessed.
Zubrod ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	151 participants	143 participants	294 participants
	0	128 84.8%	127 88.8%	255 86.7%
	1	23 15.2%	16 11.2%	39 13.3%
		[1] Measure Description: 0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, <50% in bed during the day; 3 = Symptomatic, >50% in bed, but not bedbound; 4 = Bedbound; 5 = Death

Outcome Measures

1.Primary Outcome


Title	Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years
Description	The EPIC is a prostate cancer health-related quality of life (HRQOL) s...
Description	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.
Time Frame	Baseline (randomization), 2 years

Outcome Measure Data

Analysis Population Description

Eligible participants with baseline and two-year data


Arm/Group Title	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
Arm/Group Description:	Conventional post-prostatectomy rad...	Hypofractionated post-prostatectomy...
Arm/Group Description:	Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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.	Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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.
Overall Number of Participants Analyzed	127	117
Mean (Standard Deviation) Unit of Measure: units on a scale
	-4.12 (14.72)	-5.06 (15.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	Null hypothesis (H0): mean change score of HYPORT (∆2) is worse than that of COPORT (∆1), specifically ∆2 - ∆1 < -5. Alternative hypothesis (HA): ∆2 is not worse than ∆1, specifically ∆2 - ∆1 ≥ -5. The study sample size is based on 90% power for this endpoint and 91% power for the bowel endpoint (resulting in 81.9% statistical power to reject the null hypothesis for both endpoints) and a one-sided alpha=0.025 with an overall type I error of 0.05 with a Bonferroni adjustment.
	Type of Statistical Test	Non-Inferiority
	Comments	The non-inferiority margin for the difference in mean change score (∆2 - ∆1) is -5.

Statistical Test of Hypothesis	P-Value	0.98
	Comments	[Not Specified]
	Method	t-test, 1 sided
	Comments	[Not Specified]

2.Primary Outcome


Title	Change in Bowel Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years
Description	The EPIC is a prostate cancer health-related quality of life (HRQOL) s...
Description	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.
Time Frame	Baseline, 2 years

Outcome Measure Data

Analysis Population Description

Eligible participants with baseline and two-year data


Arm/Group Title	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
Arm/Group Description:	Conventional post-prostatectomy rad...	Hypofractionated post-prostatectomy...
Arm/Group Description:	Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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.	Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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.
Overall Number of Participants Analyzed	127	117
Mean (Standard Error) Unit of Measure: units on a scale
	-1.42 (8.35)	-4.21 (11.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	Null hypothesis (H0): mean change score of HYPORT (∆2) is worse than that of COPORT (∆1), specifically ∆2 - ∆1 < -5. Alternative hypothesis (HA): ∆2 is not worse than ∆1, specifically ∆2 - ∆1 ≥ -5. The study sample size is based on 91% power for this endpoint and 90% power for the urinary endpoint (resulting in 81.9% statistical power to reject the null hypothesis for both endpoints) and a one-sided alpha=0.025 with an overall type I error of 0.05 with a Bonferroni adjustment.
	Type of Statistical Test	Non-Inferiority
	Comments	The non-inferiority margin for the difference in mean change score (∆2 - ∆1) is -6.

Statistical Test of Hypothesis	P-Value	0.96
	Comments	[Not Specified]
	Method	t-test, 1 sided
	Comments	[Not Specified]

3.Secondary Outcome


Title	Change in Urinary Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of Radiation Therapy (RT), 6 Months, 1 and 5 Years
Description	The EPIC is a prostate cancer health-related quality of life (HRQOL) s...
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

Eligible participants with baseline data


Arm/Group Title	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
Arm/Group Description:	Conventional post-prostatectomy rad...	Hypofractionated post-prostatectomy...
Arm/Group Description:	Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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.	Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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.
Overall Number of Participants Analyzed	151	143
Mean (Standard Deviation) Unit of Measure: units on a scale
End of RT	-4.34 (22.61)	-7.90 (20.93)
6 months	0.08 (20.26)	-1.71 (18.55)
1 year	-2.32 (22.63)	-5.41 (21.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	End of RT
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.70
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.67
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	1 year
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.66
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

4.Secondary Outcome


Title	Change in Bowel Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of RT, 6 Months, 1 and 5 Years
Description	The EPIC is a prostate cancer health-related quality of life (HRQOL) s...
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

Eligible participants with baseline data


Arm/Group Title	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
Arm/Group Description:	Conventional post-prostatectomy rad...	Hypofractionated post-prostatectomy...
Arm/Group Description:	Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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.	Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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.
Overall Number of Participants Analyzed	151	143
Mean (Standard Deviation) Unit of Measure: units on a scale
End of RT	-6.83 (15.82)	-14.96 (21.32)
6 months	-1.90 (13.63)	-2.70 (13.98)
1 year	-2.67 (12.65)	-3.11 (13.93)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	End of RT
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0011
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.93
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	1 year
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.30
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

5.Secondary Outcome


Title	Percentage of Participants With Biochemical Failure
Description	Biochemical failure was analyzed using two different definitions. The ...
Description	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.
Time Frame	From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years.

Outcome Measure Data

Analysis Population Description

Eligible participants


Arm/Group Title	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
Arm/Group Description:	Conventional post-prostatectomy rad...	Hypofractionated post-prostatectomy...
Arm/Group Description:	Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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.	Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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.
Overall Number of Participants Analyzed	151	143
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
Protocol definition	8.3 (4.5 to 13.6)	11.8 (7.0 to 17.9)
Phoenix definition	3.5 (1.3 to 7.4)	8.0 (4.2 to 13.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	Protocol definition of biochemical failure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.29
	Comments	[Not Specified]
	Method	Gray's test
	Comments	Two-sided significance level 0.05

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	Phoenix definition of biochemical failure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.22
	Comments	[Not Specified]
	Method	Gray's test
	Comments	Two-sided significance level 0.05

6.Secondary Outcome


Title	Percentage of Participants With Progression
Description	Progression (failure) is defined as the first occurrence of biochemica...
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

Eligible participants


Arm/Group Title	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
Arm/Group Description:	Conventional post-prostatectomy rad...	Hypofractionated post-prostatectomy...
Arm/Group Description:	Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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.	Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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.
Overall Number of Participants Analyzed	151	143
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	14.4 (9.3 to 20.6)	14.7 (9.3 to 21.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.96
	Comments	Two-sided significance level 0.05
	Method	Gray's test
	Comments	[Not Specified]

7.Secondary Outcome


Title	Percentage of Participants With Local-Regional Failure
Description	Local-regional failure is defined as local or regional failure. Local ...
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

Eligible participants


Arm/Group Title	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
Arm/Group Description:	Conventional post-prostatectomy rad...	Hypofractionated post-prostatectomy...
Arm/Group Description:	Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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.	Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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.
Overall Number of Participants Analyzed	151	143
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	0.7 (0.1 to 3.5)	0.8 (0.1 to 3.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.35
	Comments	Two-sided significance level 0.05
	Method	Gray's test
	Comments	[Not Specified]

8.Secondary Outcome


Title	Percentage of Participants Receiving Salvage Therapy
Description	Salvage therapy is defined as the initiation of new unplanned anticanc...
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

Eligible participants


Arm/Group Title	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
Arm/Group Description:	Conventional post-prostatectomy rad...	Hypofractionated post-prostatectomy...
Arm/Group Description:	Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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.	Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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.
Overall Number of Participants Analyzed	151	143
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	7.5 (3.9 to 12.5)	5.8 (2.7 to 10.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.41
	Comments	Two-sided significance level 0.05
	Method	Gray's test
	Comments	[Not Specified]

9.Secondary Outcome


Title	Percentage of Participants With Distant Metastasis
Description	Distant metastasis (failure) is defined as radiographic evidence of he...
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

Eligible participants


Arm/Group Title	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
Arm/Group Description:	Conventional post-prostatectomy rad...	Hypofractionated post-prostatectomy...
Arm/Group Description:	Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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.	Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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.
Overall Number of Participants Analyzed	151	143
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	0.7 (0.1 to 3.5)	2.2 (0.6 to 5.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.60
	Comments	Two-sided significance level 0.05
	Method	Gray's test
	Comments	[Not Specified]

10.Secondary Outcome


Title	Percentage of Participants Who Died From Prostate Cancer (Prostate Cancer Specific Mortality)
Description	Cause of death was centrally reviewed. Count and percentage at time of...
Description	Cause of death was centrally reviewed. Count and percentage at time of analysis are reported.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

Eligible participants


Arm/Group Title	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
Arm/Group Description:	Conventional post-prostatectomy rad...	Hypofractionated post-prostatectomy...
Arm/Group Description:	Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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.	Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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.
Overall Number of Participants Analyzed	151	143
Measure Type: Count of Participants Unit of Measure: Participants
	0 0.0%	0 0.0%

11.Secondary Outcome


Title	Percent of Participants Alive (Overall Survival)
Description	Overall survival time is defined as time from registration/randomizati...
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

Eligible participants


Arm/Group Title	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
Arm/Group Description:	Conventional post-prostatectomy rad...	Hypofractionated post-prostatectomy...
Arm/Group Description:	Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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.	Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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.
Overall Number of Participants Analyzed	151	143
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	98.6 (97.0 to 100.0)	98.5 (96.8 to 100.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.61
	Comments	Two-side significance level 0.05
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.58
	Confidence Interval	(2-Sided) 95% 0.26 to 9.47
	Estimation Comments	Reference = COPORT

12.Secondary Outcome


Title	Number of Participants With Grade 3+ Adverse Events
Description	Common Terminology Criteria for Adverse Events (CTCAE) version 4 grade...
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

Eligible with adverse event data


Arm/Group Title	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
Arm/Group Description:	Conventional post-prostatectomy rad...	Hypofractionated post-prostatectomy...
Arm/Group Description:	Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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.	Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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.
Overall Number of Participants Analyzed	148	141
Measure Type: Count of Participants Unit of Measure: Participants
All adverse events	25 16.9%	20 14.2%
Gastrointestinal Adverse Events	3 2.0%	2 1.4%
Genitourinary Adverse Events	6 4.1%	10 7.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	Patients with any grade 3 or higher adverse event of any attribution
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.53
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	Patients with any grade 3 or higher gastrointestinal adverse event of any attribution
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6929
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Conventional Radiation Therapy, Hypofractionated Radiation Therapy
	Comments	Patients with any grade 3 or higher genitourinary adverse event of any attribution
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2605
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.

Arm/Group Title	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
Arm/Group Description	Conventional post-prostatectomy rad...	Hypofractionated post-prostatectomy...
Arm/Group Description	Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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.	Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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.
All-Cause Mortality
	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/151 (0.00%)	0/143 (0.00%)
Serious Adverse Events Serious Adverse Events
	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/148 (0.68%)	8/141 (5.67%)
Cardiac disorders
Myocardial infarction ^* 1	0/148 (0.00%)	1/141 (0.71%)
Gastrointestinal disorders
Proctitis ^* 1	0/148 (0.00%)	1/141 (0.71%)
Immune system disorders
Anaphylaxis ^* 1	0/148 (0.00%)	1/141 (0.71%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy ^* 1	0/148 (0.00%)	1/141 (0.71%)
Renal and urinary disorders
Cystitis noninfective ^* 1	0/148 (0.00%)	3/141 (2.13%)
Hematuria ^* 1	0/148 (0.00%)	1/141 (0.71%)
Renal and urinary disorders - Other ^* 1	0/148 (0.00%)	1/141 (0.71%)
Renal calculi ^* 1	1/148 (0.68%)	1/141 (0.71%)
Urinary retention ^* 1	0/148 (0.00%)	1/141 (0.71%)
Reproductive system and breast disorders
Pelvic pain ^* 1	0/148 (0.00%)	1/141 (0.71%)
1 Term from vocabulary, CTCAE (4.0) * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Conventional Radiation Therapy	Hypofractionated Radiation Therapy
	Affected / at Risk (%)	Affected / at Risk (%)
Total	130/148 (87.84%)	120/141 (85.11%)
Gastrointestinal disorders
Abdominal pain ^* 1	8/148 (5.41%)	5/141 (3.55%)
Constipation ^* 1	17/148 (11.49%)	17/141 (12.06%)
Diarrhea ^* 1	43/148 (29.05%)	53/141 (37.59%)
Gastrointestinal disorders - Other ^* 1	13/148 (8.78%)	17/141 (12.06%)
Proctitis ^* 1	8/148 (5.41%)	18/141 (12.77%)
Rectal hemorrhage ^* 1	6/148 (4.05%)	18/141 (12.77%)
General disorders
Fatigue ^* 1	80/148 (54.05%)	62/141 (43.97%)
Infections and infestations
Urinary tract infection ^* 1	8/148 (5.41%)	2/141 (1.42%)
Musculoskeletal and connective tissue disorders
Back pain ^* 1	8/148 (5.41%)	7/141 (4.96%)
Renal and urinary disorders
Cystitis noninfective ^* 1	12/148 (8.11%)	10/141 (7.09%)
Hematuria ^* 1	9/148 (6.08%)	20/141 (14.18%)
Renal and urinary disorders - Other ^* 1	36/148 (24.32%)	22/141 (15.60%)
Urinary frequency ^* 1	75/148 (50.68%)	73/141 (51.77%)
Urinary incontinence ^* 1	45/148 (30.41%)	48/141 (34.04%)
Urinary retention ^* 1	14/148 (9.46%)	9/141 (6.38%)
Urinary tract pain ^* 1	11/148 (7.43%)	15/141 (10.64%)
Urinary urgency ^* 1	43/148 (29.05%)	45/141 (31.91%)
Reproductive system and breast disorders
Erectile dysfunction ^* 1	24/148 (16.22%)	18/141 (12.77%)
Vascular disorders
Hot flashes ^* 1	37/148 (25.00%)	32/141 (22.70%)
Hypertension ^* 1	8/148 (5.41%)	11/141 (7.80%)
1 Term from vocabulary, CTCAE (4.0) * Indicates events were collected by non-systematic assessment

Limitations and Caveats

Local and regional failure data was collected as a combined event (local-regional progression) and therefore is reported as a single outcome measure.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Wendy Seiferheld
Organization:	NRG Oncology
Phone:	215-574-3208
EMail:	seiferheldw@nrgoncology.org

Layout table for additonal information

Responsible Party:	NRG Oncology
ClinicalTrials.gov Identifier:	NCT03274687
Other Study ID Numbers:	NRG-GU003 NCI-2016-01771 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) NRG-GU003 NRG-GU003 ( Other Identifier: NRG Oncology ) NRG-GU003 ( Other Identifier: CTEP ) U10CA180868 ( U.S. NIH Grant/Contract )
First Submitted:	September 5, 2017
First Posted:	September 7, 2017
Results First Submitted:	May 10, 2022
Results First Posted:	June 6, 2022
Last Update Posted:	June 28, 2022

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