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CompletedNCT03274687Updated Jul 9, 2026Results posted

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

A Phase 3 interventional study of Hypofractionated Radiation Therapy and Laboratory Biomarker Analysis in Prostate Adenocarcinoma, Stage I Prostate Adenocarcinoma AJCC v7 and Stage II Prostate Adenocarcinoma AJCC v7, sponsored by NRG Oncology. Completed at 241 sites in 3 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by NRG Oncology · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
296
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

This randomized phase III trial studies how well hypofractionated radiation therapy works compared to conventional radiation therapy after surgery in treating patients with prostate cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Conventional radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. It is not yet known whether giving hypofractionated radiation therapy or conventional radiation therapy after surgery may work better in treating patients with prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

I. To demonstrate that hypofractionated post-prostatectomy radiotherapy (HYPORT) does not increase patient-reported gastrointestinal (GI) or genitourinary (GU) symptoms over conventionally fractionated post-prostatectomy (COPORT) at the 2-year time point.

SECONDARY OBJECTIVES:

I. To compare patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)-26 at end of radiation therapy (RT) and 6, 12, 24, and 60 months from end of treatment.

II. To compare patient-reported GU symptoms using the EPIC-26 at end of RT and 6, 12, 24, and 60 months from end of treatment.

III. To compare time to progression (TTP) where progression is defined as the first occurrence of biochemical failure (BF), local failure, regional failure, distant metastasis (DM), institution of new unplanned anticancer treatment, or death from prostate cancer (prostate cancer specific mortality [PCSM]).

IV. To compare freedom from biochemical failure (FFBF) and TTP rates with an alternate prostate specific antigen (PSA) >= PSA nadir + 2 ng/mL definition of BF.

V. To compare local failure, regional failure, salvage therapy (i.e. institution of new unplanned anticancer treatment), DM, PCSM, and overall survival (OS) rates.

VI. Assessment of adverse events.

EXPLORATORY OBJECTIVES:

I. To compare utilities for health outcomes using the EuroQol five dimensions questionnaire (EQ-5D).

II. Paraffin-embedded tissue block, serum, plasma, whole blood, and urine for future translational research analyses for predictors of toxicity following hypofractionated or conventionally fractionated post-prostatectomy radiotherapy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo conventional radiation therapy for 37 fractions over 7 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive androgen deprivation therapy for up to 6 months as per doctor recommendation.

ARM II: Patients undergo hypofractionated radiation therapy for 25 fractions over 5 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive androgen deprivation therapy for up to 6 months as per doctor recommendation.

After completion of study treatment, patients are followed up every 6 months for 2 years and every year for 3 years and thereafter.

02

Conditions studied

  • Prostate Adenocarcinoma
  • Stage I Prostate Adenocarcinoma AJCC v7
  • Stage II Prostate Adenocarcinoma AJCC v7
  • Stage III Prostate Adenocarcinoma AJCC v7
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • PRIOR TO STEP 1 REGISTRATION

  • Adenocarcinoma of the prostate treated primarily with radical prostatectomy

    • Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic, or robotically assisted; there is no time limit for the date of radical prostatectomy

  • One of the following pathologic T-classifications: pT2 or pT3

    • Patients with positive surgical margins are eligible

  • One of the following pathologic N-classifications: pN0, pNX

    • If a lymph node dissection is performed, the number of lymph nodes removed per side of the pelvis and the extent of the pelvic lymph node dissection (obturator versus [vs.] extended lymph node dissection) should be noted whenever possible

  • No clinical evidence of regional lymph node metastasis

    • Computed tomography (CT) (with contrast if renal function is acceptable; a noncontrast CT is permitted if the patient is not a candidate for contrast), magnetic resonance imaging (MRI), nodal sampling, or dissection of the pelvis within 120 days prior to step 1 registration
    • Patients with pelvic lymph nodes equivocal or questionable by imaging are eligible if the nodes are =\< 1 cm in the short axis
  • A post-radical prostatectomy study entry PSA >= 45 days after prostatectomy and within 30 days prior to step 1, \< 2.0 ng/mL

  • No evidence of a local recurrence in the prostate fossa based on a digital rectal examination (DRE) within 60 days prior to step 1 registration

    • Patients with equivocal or questionable DRE findings should have an MRI of the pelvis to exclude the presence of a prostate fossa mass
    • Patients with equivocal or questionable exam findings by DRE or MRI are eligible if a biopsy of the lesion is negative for tumor

  • No evidence of bone metastases (M0) on bone scan (Na F positron emission tomography (PET)/CT is an acceptable substitute) within 120 days prior to step 1 registration

    • Equivocal bone scan findings are allowed if plain films and/or MRI are negative for metastasis
  • Zubrod performance status 0-1 within 60 days prior to step 1 registration
  • The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration
  • Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
  • Only English and French-speaking patients are eligible to participate as these are the only language the EPIC has been validated in
  • PRIOR TO STEP 2 REGISTRATION
  • The EPIC must be completed in full and entered within 10 business days after step 1 registration; NRG Oncology Statistical and Data Management Center has 3 business days to score the results and send a notification to the site to proceed to step 2 randomization

Exclusion criteria

Exclusion Criteria:

  • A post-prostatectomy PSA nadir >= 0.2 ng/mL AND Gleason >= 7 (Considered for NRG-GU002, principal investigator [PI]: Hurwitz)
  • pT2 with a negative surgical margin and PSA \< 0.1 ng/mL

  • Androgen deprivation therapy started prior to prostatectomy for > 6 months (180 days) duration;

    • Note: The use of finasteride or dutasteride (+/- tamsulosin) for longer periods prior to prostatectomy is acceptable
  • Androgen deprivation therapy started after prostatectomy and prior to step 1 registration for > 6 weeks (42 days)
  • Neoadjuvant chemotherapy before or after prostatectomy
  • Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years and not in the pelvis; (for example, carcinoma in situ of the oral cavity is permissible if disease free for a minimum of 3 years; however, patients with prior history of bladder cancer are not allowed no matter the disease free duration); prior hematological (e.g., leukemia, lymphoma, myeloma) malignancy is not allowed
  • Previous chemotherapy for any other disease site if given within 3 years prior to step 1
  • Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy treatment volumes

  • Severe, active co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 1 registration
    • Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
    • Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count \< 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
    • End-stage renal disease (ie, on dialysis or dialysis has been recommended)
  • Prior allergic reaction to the study drugs involved in this protocol
  • History of inflammatory bowel disease, prior bowel surgeries (or colostomy) for any reason, or prior partial/radical cystectomy for any reason
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
296 participants (actual)

Study arms

  • Experimental
    Arm I (conventional radiation therapy)

    Patients undergo conventional radiation therapy for 37 fractions over 7 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive androgen deprivation therapy for up to 6 months as per doctor recommendation.

    Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment · Radiation: Radiation Therapy

  • Experimental
    Arm II (hypofractionated radiation therapy

    Patients undergo hypofractionated radiation therapy for 25 fractions over 5 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive androgen deprivation therapy for up to 6 months as per doctor recommendation.

    Radiation: Hypofractionated Radiation Therapy · Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment

Interventions

  • RadiationHypofractionated Radiation Therapy

    Undergo hypofractionated radiation therapy

    Also known as: Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • OtherQuality-of-Life Assessment

    Ancillary studies

    Also known as: Quality of Life Assessment

  • RadiationRadiation Therapy

    Undergo conventional radiation therapy

    Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

05

What researchers measure

Primary outcomes

  1. Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years

    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

  2. Change in Bowel Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years

    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

Secondary outcomes

  1. Change in Urinary Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of Radiation Therapy (RT), 6 Months, 1 and 5 Years

    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.

  2. Change in Bowel Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of RT, 6 Months, 1 and 5 Years

    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.

  3. Percentage of Participants With Biochemical Failure

    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.

  4. Percentage of Participants With Progression

    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.

  5. Percentage of Participants With Local-Regional Failure

    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.

  6. Percentage of Participants Receiving Salvage Therapy

    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.

  7. Percentage of Participants With Distant Metastasis

    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.

  8. Percentage of Participants Who Died From Prostate Cancer (Prostate Cancer Specific Mortality)

    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.

  9. Percent of Participants Alive (Overall Survival)

    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.

  10. Number of Participants With Grade 3+ Adverse Events

    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.

Other outcomes

  1. Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years by Ethnicity

    NIH-required analysis. 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

  2. Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years by Race

    NIH-required analysis. 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

06

Results

Posted Jun 6, 2022
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.

Participant flow

Participant flow — Overall Study
MilestoneConventional Radiation TherapyHypofractionated Radiation Therapy
Started152144
Eligible151143
Eligible with adverse event data148141
Completed151143
Not completed11
Withdrew: Protocol violation11

Outcome measures

PrimaryChange in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years

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
Reported as:
Mean · units on a scale
Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years
units on a scaleConventional Radiation TherapyHypofractionated Radiation Therapy
Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years-4.12 ± 14.72-5.06 ± 15.16
Statistical analysis
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · t-test, 1 sided · p = 0.98
PrimaryChange in Bowel Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years

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
Reported as:
Mean · units on a scale
Change in Bowel Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years
units on a scaleConventional Radiation TherapyHypofractionated Radiation Therapy
Change in Bowel Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years-1.42 ± 8.35-4.21 ± 11.0
Statistical analysis
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · t-test, 1 sided · p = 0.96
SecondaryChange in Urinary Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of Radiation Therapy (RT), 6 Months, 1 and 5 Years

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.
Reported as:
Mean · units on a scale
Change in Urinary Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of Radiation Therapy (RT), 6 Months, 1 and 5 Years
units on a scaleConventional Radiation TherapyHypofractionated Radiation Therapy
End of RT-4.34 ± 22.61-7.90 ± 20.93
6 months0.08 ± 20.26-1.71 ± 18.55
1 year-2.32 ± 22.63-5.41 ± 21.15
Statistical analysis
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · t-test, 2 sided · p = 0.70
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · t-test, 2 sided · p = 0.67
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · t-test, 2 sided · p = 0.66
SecondaryChange in Bowel Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of RT, 6 Months, 1 and 5 Years

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.
Reported as:
Mean · units on a scale
Change in Bowel Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of RT, 6 Months, 1 and 5 Years
units on a scaleConventional Radiation TherapyHypofractionated Radiation Therapy
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
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · t-test, 2 sided · p = 0.0011
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · t-test, 2 sided · p = 0.93
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · t-test, 2 sided · p = 0.30
SecondaryPercentage of Participants With Biochemical Failure

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.
Reported as:
Number · percentage of participants
Percentage of Participants With Biochemical Failure
percentage of participantsConventional Radiation TherapyHypofractionated Radiation Therapy
Protocol definition8.3 (4.5 to 13.6)11.8 (7.0 to 17.9)
Phoenix definition3.5 (1.3 to 7.4)8.0 (4.2 to 13.3)
Statistical analysis
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · Gray's test · p = 0.29Two-sided significance level 0.05
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · Gray's test · p = 0.22Two-sided significance level 0.05
SecondaryPercentage of Participants With Progression

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.
Reported as:
Number · percentage of participants
Percentage of Participants With Progression
percentage of participantsConventional Radiation TherapyHypofractionated Radiation Therapy
Percentage of Participants With Progression14.4 (9.3 to 20.6)14.7 (9.3 to 21.2)
Statistical analysis
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · Gray's test · p = 0.96 (Two-sided significance level 0.05)
SecondaryPercentage of Participants With Local-Regional Failure

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.
Reported as:
Number · percentage of participants
Percentage of Participants With Local-Regional Failure
percentage of participantsConventional Radiation TherapyHypofractionated Radiation Therapy
Percentage of Participants With Local-Regional Failure0.7 (0.1 to 3.5)0.8 (0.1 to 3.8)
Statistical analysis
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · Gray's test · p = 0.35 (Two-sided significance level 0.05)
SecondaryPercentage of Participants Receiving Salvage Therapy

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.
Reported as:
Number · percentage of participants
Percentage of Participants Receiving Salvage Therapy
percentage of participantsConventional Radiation TherapyHypofractionated Radiation Therapy
Percentage of Participants Receiving Salvage Therapy7.5 (3.9 to 12.5)5.8 (2.7 to 10.6)
Statistical analysis
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · Gray's test · p = 0.41 (Two-sided significance level 0.05)
SecondaryPercentage of Participants With Distant Metastasis

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.
Reported as:
Number · percentage of participants
Percentage of Participants With Distant Metastasis
percentage of participantsConventional Radiation TherapyHypofractionated Radiation Therapy
Percentage of Participants With Distant Metastasis0.7 (0.1 to 3.5)2.2 (0.6 to 5.8)
Statistical analysis
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · Gray's test · p = 0.60 (Two-sided significance level 0.05)
SecondaryPercentage of Participants Who Died From Prostate Cancer (Prostate Cancer Specific Mortality)

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.
Reported as:
Count of participants · Participants
Percentage of Participants Who Died From Prostate Cancer (Prostate Cancer Specific Mortality)
ParticipantsConventional Radiation TherapyHypofractionated Radiation Therapy
Percentage of Participants Who Died From Prostate Cancer (Prostate Cancer Specific Mortality)00
SecondaryPercent of Participants Alive (Overall Survival)

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.
Reported as:
Number · percentage of participants
Percent of Participants Alive (Overall Survival)
percentage of participantsConventional Radiation TherapyHypofractionated Radiation Therapy
Percent of Participants Alive (Overall Survival)98.6 (97.0 to 100.0)98.5 (96.8 to 100.0)
Statistical analysis
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · Log Rank · p = 0.61 (Two-side significance level 0.05) · Hazard ratio (hr): 1.58 · 95% CI 0.26 to 9.47Reference = COPORT
SecondaryNumber of Participants With Grade 3+ Adverse Events

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.
Reported as:
Count of participants · Participants
Number of Participants With Grade 3+ Adverse Events
ParticipantsConventional Radiation TherapyHypofractionated Radiation Therapy
All adverse events2520
Gastrointestinal Adverse Events32
Genitourinary Adverse Events610
Statistical analysis
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · Chi-squared · p = 0.53
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · Chi-squared · p = 0.6929
  • Conventional Radiation Therapy vs Hypofractionated Radiation Therapy · Chi-squared · p = 0.2605
Other pre-specifiedChange in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years by Ethnicity

NIH-required analysis. 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
Reported as:
Mean · units on a scale
Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years by Ethnicity
units on a scaleConventional Radiation TherapyHypofractionated Radiation Therapy
Hispanic or Latino-4.15 ± 9.66-10.60 ± 21.69
Not Hispanic or Latino-4.17 ± 14.95-4.81 ± 15.02
Unknown or Not Reported2.42 ± 6.36-5.21 ± 10.31
Other pre-specifiedChange in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years by Race

NIH-required analysis. 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
Reported as:
Mean · units on a scale
Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years by Race
units on a scaleConventional Radiation TherapyHypofractionated Radiation Therapy
Asian-11.79 ± 1.004.37 ± 16.05
Black or African American-1.39 ± 14.63-6.80 ± 13.05
White-4.37 ± 14.86-5.18 ± 15.49
Unknown or not reported-2.08 ± NA-6.25 ± 8.54

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Conventional Radiation Therapy0/151 (0%)1/148 (0.7%)130/148 (87.8%)
Hypofractionated Radiation Therapy0/143 (0%)8/141 (5.7%)120/141 (85.1%)
Most frequent serious events
Most frequent serious events
EventConventional Radiation TherapyHypofractionated Radiation Therapy
Cystitis noninfectiveRenal and urinary disorders0/1483/141
Myocardial infarctionCardiac disorders0/1481/141
ProctitisGastrointestinal disorders0/1481/141
AnaphylaxisImmune system disorders0/1481/141
Treatment related secondary malignancyNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1481/141
HematuriaRenal and urinary disorders0/1481/141
Renal and urinary disorders - OtherRenal and urinary disorders0/1481/141
Renal calculiRenal and urinary disorders1/1481/141
Urinary retentionRenal and urinary disorders0/1481/141
Pelvic painReproductive system and breast disorders0/1481/141
Most frequent other events
Showing 10 of 20
Most frequent other events
EventConventional Radiation TherapyHypofractionated Radiation Therapy
FatigueGeneral disorders80/14862/141
Urinary frequencyRenal and urinary disorders75/14873/141
DiarrheaGastrointestinal disorders43/14853/141
Urinary incontinenceRenal and urinary disorders45/14848/141
Urinary urgencyRenal and urinary disorders43/14845/141
Hot flashesVascular disorders37/14832/141
Renal and urinary disorders - OtherRenal and urinary disorders36/14822/141
Erectile dysfunctionReproductive system and breast disorders24/14818/141
HematuriaRenal and urinary disorders9/14820/141
ProctitisGastrointestinal disorders8/14818/141

Baseline characteristics

Eligible participants

Age, Customized
Age, Customized(Participants)Conventional Radiation TherapyHypofractionated Radiation TherapyTotal
≤ 49 years325
50 - 59 years273158
60 - 69 years7483157
≥ 70 years472774
Sex: Female, Male
Sex: Female, Male(Participants)Conventional Radiation TherapyHypofractionated Radiation TherapyTotal
Female000
Male151143294
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Conventional Radiation TherapyHypofractionated Radiation TherapyTotal
Hispanic or Latino7512
Not Hispanic or Latino142136278
Unknown or Not Reported224
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Conventional Radiation TherapyHypofractionated Radiation TherapyTotal
American Indian or Alaska Native000
Asian257
Native Hawaiian or Other Pacific Islander000
Black or African American222143
White125114239
More than one race000
Unknown or Not Reported235
EPIC Group
EPIC Group(Participants)Conventional Radiation TherapyHypofractionated Radiation TherapyTotal
A Score Group (bowel domain score > 96, urinary domain score > 84)5652108
B Score Group (bowel domain score > 96, urinary domain score ≤ 84)293261
C Score Group (bowel domain score ≤ 96, urinary domain score > 84)313162
D Score Group (bowel domain score ≤ 96, urinary domain score ≤ 84)352863
Prior androgen deprivation therapy (ADT)
Prior androgen deprivation therapy (ADT)(Participants)Conventional Radiation TherapyHypofractionated Radiation TherapyTotal
No118110228
Yes333366
Prostate-specific antigen (PSA) ng/mL
Prostate-specific antigen (PSA) ng/mL(Participants)Conventional Radiation TherapyHypofractionated Radiation TherapyTotal
0.0 - 0.5135128263
0.6 - 1.0101424
1.1 - 1.5314
1.6 - 2.0303
Gleason score
Gleason score(Participants)Conventional Radiation TherapyHypofractionated Radiation TherapyTotal
616723
7105109214
8141529
9151126
10112

3 further baseline measures are reported on the registry.

07

Study locations

241 sites
  • University of Alabama at Birmingham Cancer Center
    Birmingham, Alabama 35233, United States
  • University of South Alabama Mitchell Cancer Institute
    Mobile, Alabama 36688, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Marin Cancer Care Inc
    Greenbrae, California 94904, United States
  • Marin General Hospital
    Greenbrae, California 94904, United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, United States
  • Los Angeles General Medical Center
    Los Angeles, California 90033, United States
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • Fremont - Rideout Cancer Center
    Marysville, California 95901, United States
  • Kaiser Permanente Oakland-Broadway
    Oakland, California 94611, United States
  • Stanford Cancer Institute Palo Alto
    Palo Alto, California 94304, United States
  • Pomona Valley Hospital Medical Center
    Pomona, California 91767, United States
  • Kaiser Permanente-Rancho Cordova Cancer Center
    Rancho Cordova, California 95670, United States
  • Rohnert Park Cancer Center
    Rohnert Park, California 94928, United States
  • The Permanente Medical Group-Roseville Radiation Oncology
    Roseville, California 95678, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • South Sacramento Cancer Center
    Sacramento, California 95823, United States
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California 95051, United States
  • Kaiser Permanente Cancer Treatment Center
    South San Francisco, California 94080, United States
  • Gene Upshaw Memorial Tahoe Forest Cancer Center
    Truckee, California 96161, United States
  • UCHealth University of Colorado Hospital
    Aurora, Colorado 80045, United States
  • Penrose-Saint Francis Healthcare
    Colorado Springs, Colorado 80907, United States
  • UCHealth Memorial Hospital Central
    Colorado Springs, Colorado 80909, United States
  • Yale University
    New Haven, Connecticut 06520, United States
  • Helen F Graham Cancer Center
    Newark, Delaware 19713, United States
  • Christiana Care Health System-Christiana Hospital
    Newark, Delaware 19718, United States
  • Beebe Health Campus
    Rehoboth Beach, Delaware 19971, United States
  • TidalHealth Nanticoke / Allen Cancer Center
    Seaford, Delaware 19973, United States
  • UM Sylvester Comprehensive Cancer Center at Coral Gables
    Coral Gables, Florida 33146, United States
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
    Deerfield Beach, Florida 33442, United States
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
    Miami, Florida 33136, United States
  • Cleveland Clinic-Weston
    Weston, Florida 33331, United States
  • Grady Health System
    Atlanta, Georgia 30303, United States
  • Emory University Hospital Midtown
    Atlanta, Georgia 30308, United States
  • Emory University Hospital/Winship Cancer Institute
    Atlanta, Georgia 30322, United States
  • Emory Saint Joseph's Hospital
    Atlanta, Georgia 30342, United States
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    Savannah, Georgia 31405, United States
  • Queen's Medical Center
    Honolulu, Hawaii 96813, United States
  • The Cancer Center of Hawaii-Liliha
    Honolulu, Hawaii 96817, United States
  • The Cancer Center of Hawaii-Pali Momi
    ‘Aiea, Hawaii 96701, United States
  • SIH Cancer Institute
    Carterville, Illinois 62918, United States
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
  • Decatur Memorial Hospital
    Decatur, Illinois 62526, United States
  • Crossroads Cancer Center
    Effingham, Illinois 62401, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • UC Comprehensive Cancer Center at Silver Cross
    New Lenox, Illinois 60451, United States
  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
    Peoria, Illinois 61615, United States
  • OSF Saint Francis Medical Center
    Peoria, Illinois 61637, United States
  • UW Health Carbone Cancer Center Rockford
    Rockford, Illinois 61114, United States
  • Carle Cancer Center
    Urbana, Illinois 61801, United States
  • Goshen Center for Cancer Care
    Goshen, Indiana 46526, United States
  • McFarland Clinic - Ames
    Ames, Iowa 50010, United States
  • Iowa Methodist Medical Center
    Des Moines, Iowa 50309, United States
  • University of Kansas Cancer Center
    Kansas City, Kansas 66160, United States
  • The University of Kansas Cancer Center - Olathe
    Olathe, Kansas 66061, United States
  • University of Kansas Cancer Center-Overland Park
    Overland Park, Kansas 66210, United States
  • Cotton O'Neil Cancer Center / Stormont Vail Health
    Topeka, Kansas 66606, United States
  • Ascension Via Christi Hospitals Wichita
    Wichita, Kansas 67214, United States
  • Owensboro Health Mitchell Memorial Cancer Center
    Owensboro, Kentucky 42303, United States
  • East Jefferson General Hospital
    Metairie, Louisiana 70006, United States
  • Ochsner Medical Center Jefferson
    New Orleans, Louisiana 70121, United States
  • MaineHealth Maine Medical Center - Portland
    Portland, Maine 04102, United States
  • MaineHealth Maine Medical Center- Scarborough
    Scarborough, Maine 04074, United States
  • University of Maryland/Greenebaum Cancer Center
    Baltimore, Maryland 21201, United States
  • Central Maryland Radiation Oncology in Howard County
    Columbia, Maryland 21044, United States
  • University of Maryland Radiation Oncology Center at Union Hospital
    Elkton, Maryland 21921, United States
  • UM Baltimore Washington Medical Center/Tate Cancer Center
    Glen Burnie, Maryland 21061, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
  • Lowell General Hospital
    Lowell, Massachusetts 01854, United States
  • Beth Israel Deaconess Hospital-Plymouth
    Plymouth, Massachusetts 02360, United States
  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
    Ann Arbor, Michigan 48106, United States
  • Henry Ford Cancer Institute-Downriver
    Brownstown, Michigan 48183, United States
  • McLaren Cancer Institute-Clarkston
    Clarkston, Michigan 48346, United States
  • Michigan Healthcare Professionals Clarkston
    Clarkston, Michigan 48346, United States
  • Henry Ford Macomb Hospital-Clinton Township
    Clinton Township, Michigan 48038, United States
  • Wayne State University/Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • Michigan Healthcare Professionals Farmington
    Farmington Hills, Michigan 48334, United States
  • Weisberg Cancer Treatment Center
    Farmington Hills, Michigan 48334, United States
  • Genesys Hurley Cancer Institute
    Flint, Michigan 48503, United States
  • McLaren Cancer Institute-Flint
    Flint, Michigan 48532, United States
  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
    Grand Rapids, Michigan 49503, United States
  • Trinity Health Grand Rapids Hospital
    Grand Rapids, Michigan 49503, United States
  • West Michigan Cancer Center
    Kalamazoo, Michigan 49007, United States
  • Karmanos Cancer Institute at McLaren Greater Lansing
    Lansing, Michigan 48910, United States
  • University of Michigan Health - Sparrow Lansing
    Lansing, Michigan 48912, United States
  • McLaren Cancer Institute-Lapeer Region
    Lapeer, Michigan 48446, United States
  • Trinity Health Saint Mary Mercy Livonia Hospital
    Livonia, Michigan 48154, United States
  • McLaren Cancer Institute-Macomb
    Mount Clemens, Michigan 48043, United States
  • McLaren Cancer Institute-Central Michigan
    Mount Pleasant, Michigan 48858, United States
  • McLaren Cancer Institute-Owosso
    Owosso, Michigan 48867, United States
  • McLaren Cancer Institute-Northern Michigan
    Petoskey, Michigan 49770, United States
  • Trinity Health Saint Joseph Mercy Oakland Hospital
    Pontiac, Michigan 48341, United States
  • McLaren-Port Huron
    Port Huron, Michigan 48060, United States
  • Michigan Healthcare Professionals Troy
    Troy, Michigan 48098, United States
  • Henry Ford West Bloomfield Hospital
    West Bloomfield, Michigan 48322, United States
  • University of Michigan Health - West
    Wyoming, Michigan 49519, United States
  • Saint Luke's Hospital of Duluth
    Duluth, Minnesota 55805, United States

Showing the first 100 of 241 sites across 3 countries.

08

References and documents

Publications

  • Buyyounouski MK, Pugh SL, Chen RC, Mann MJ, Kudchadker RJ, Konski AA, Mian OY, Michalski JM, Vigneault E, Valicenti RK, Barkati M, Lawton CAF, Potters L, Monitto DC, Kittel JA, Schroeder TM, Hannan R, Duncan CE, Rodgers JP, Feng F, Sandler HM. Noninferiority of Hypofractionated vs Conventional Postprostatectomy Radiotherapy for Genitourinary and Gastrointestinal Symptoms: The NRG-GU003 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2024 May 1;10(5):584-591. doi: 10.1001/jamaoncol.2023.7291. PubMed 38483412 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 26, 2019
  • Informed consent form · Apr 26, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

09

Registry details

Key details

Study ID
NCT03274687
Lead sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 7, 2017
Start date
Jul 28, 2017
Primary completion
Feb 22, 2021
Completion
Dec 23, 2025
Results posted
Jun 6, 2022
Last update
Jul 9, 2026

Study contacts

Mark K Buyyounouski
principal investigator · NRG Oncology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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