A Randomized Phase III Trial of Hypofractionated Post-prostatectomy Radiation Therapy (HYPORT) Versus Conventional Post-prostatectomy Radiation Therapy (COPORT)
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.
- 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
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- 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
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- 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
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- 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
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- 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
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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
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- (for example, carcinoma in situ of the oral cavity is permissible if disease free for a minimum of 3 years
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- however, patients with prior history of bladder cancer are not allowed no matter the disease free duration)
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- 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
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- 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
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- 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
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- Neoplasms by Histologic Type
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