Hypofractionated Radiation Therapy or Conventional Radiation Therapy After Surgery in Treating Patients With Prostate Cancer
Prostate Adenocarcinoma, Stage I Prostate Adenocarcinoma, Stage II Prostate Adenocarcinoma
About this trial
This is an interventional treatment trial for Prostate Adenocarcinoma
Eligibility Criteria
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-26) questionnaire
- Only English and French-speaking patients are eligible to participate
- PRIOR TO STEP 2 REGISTRATION
- The EPIC-26 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:
- A post-prostatectomy PSA nadir >= 0.2 ng/mL AND Gleason >= 7
- 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 CD4 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
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- University of South Alabama Mitchell Cancer Institute
- University of Arkansas for Medical Sciences
- Marin Cancer Care Inc
- Marin General Hospital
- Kaiser Permanente Los Angeles Medical Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Cedars Sinai Medical Center
- Fremont - Rideout Cancer Center
- Kaiser Permanente Oakland-Broadway
- Stanford Cancer Institute Palo Alto
- Pomona Valley Hospital Medical Center
- Kaiser Permanente-Rancho Cordova Cancer Center
- Rohnert Park Cancer Center
- The Permanente Medical Group-Roseville Radiation Oncology
- University of California Davis Comprehensive Cancer Center
- South Sacramento Cancer Center
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente Cancer Treatment Center
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- University of Colorado Hospital
- Penrose-Saint Francis Healthcare
- UCHealth Memorial Hospital Central
- Yale University
- Helen F Graham Cancer Center
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- TidalHealth Nanticoke / Allen Cancer Center
- UM Sylvester Comprehensive Cancer Center at Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
- Mayo Clinic in Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Cleveland Clinic-Weston
- Grady Health System
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- The Cancer Center of Hawaii-Pali Momi
- Queen's Medical Center
- The Cancer Center of Hawaii-Liliha
- SIH Cancer Institute
- University of Chicago Comprehensive Cancer Center
- Decatur Memorial Hospital
- Crossroads Cancer Center
- Loyola University Medical Center
- UC Comprehensive Cancer Center at Silver Cross
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- OSF Saint Francis Medical Center
- SwedishAmerican Regional Cancer Center/ACT
- Carle Cancer Center
- Goshen Center for Cancer Care
- McFarland Clinic PC - Ames
- Iowa Methodist Medical Center
- University of Kansas Cancer Center
- Olathe Health Cancer Center
- University of Kansas Cancer Center-Overland Park
- Cotton O'Neil Cancer Center / Stormont Vail Health
- Ascension Via Christi Hospitals Wichita
- Owensboro Health Mitchell Memorial Cancer Center
- East Jefferson General Hospital
- Ochsner Medical Center Jefferson
- Maine Medical Center-Bramhall Campus
- Maine Medical Center- Scarborough Campus
- University of Maryland/Greenebaum Cancer Center
- Central Maryland Radiation Oncology in Howard County
- University of Maryland Radiation Oncology Center at Union Hospital
- UM Baltimore Washington Medical Center/Tate Cancer Center
- Boston Medical Center
- Lowell General Hospital
- Beth Israel Deaconess Hospital-Plymouth
- Saint Joseph Mercy Hospital
- Henry Ford Cancer Institute-Downriver
- 21st Century Oncology MHP - Clarkston
- McLaren Cancer Institute-Clarkston
- Henry Ford Macomb Hospital-Clinton Township
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- 21st Century Oncology MHP - Farmington
- Weisberg Cancer Treatment Center
- Genesys Hurley Cancer Institute
- McLaren Cancer Institute-Flint
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- West Michigan Cancer Center
- McLaren-Greater Lansing
- Sparrow Hospital
- McLaren Cancer Institute-Lapeer Region
- Saint Mary Mercy Hospital
- McLaren Cancer Institute-Macomb
- McLaren Cancer Institute-Central Michigan
- McLaren Cancer Institute-Owosso
- McLaren Cancer Institute-Northern Michigan
- Saint Joseph Mercy Oakland
- McLaren-Port Huron
- 21st Century Oncology MHP - Troy
- Henry Ford West Bloomfield Hospital
- Metro Health Hospital
- Saint Luke's Hospital of Duluth
- Mayo Clinic Health Systems-Mankato
- Mayo Clinic in Rochester
- Coborn Cancer Center at Saint Cloud Hospital
- Southeast Cancer Center
- Siteman Cancer Center at West County Hospital
- North Kansas City Hospital
- Kansas City Veterans Affairs Medical Center
- The University of Kansas Cancer Center-South
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- Heartland Regional Medical Center
- Washington University School of Medicine
- Siteman Cancer Center-South County
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Benefis Healthcare- Sletten Cancer Institute
- Kalispell Regional Medical Center
- Wentworth-Douglass Hospital
- Dartmouth Hitchcock Medical Center
- University of New Mexico Cancer Center
- Lovelace Radiation Oncology
- New Mexico Oncology Hematology Consultants
- Memorial Medical Center - Las Cruces
- Northwell Health Imbert Cancer Center
- New York-Presbyterian/Brooklyn Methodist Hospital
- Roswell Park Cancer Institute
- Mary Imogene Bassett Hospital
- Arnot Ogden Medical Center/Falck Cancer Center
- Northwell Health/Center for Advanced Medicine
- NYP/Weill Cornell Medical Center
- Dickstein Cancer Treatment Center
- UNC Lineberger Comprehensive Cancer Center
- Novant Health Presbyterian Medical Center
- Duke University Medical Center
- Rex Cancer Center
- NHRMC Radiation Oncology - Supply
- NHRMC Radiation Oncology - 16th Street
- Novant Health Forsyth Medical Center
- Cleveland Clinic Akron General
- UHHS-Chagrin Highlands Medical Center
- Geauga Hospital
- Adena Regional Medical Center
- Case Western Reserve University
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Mercy Cancer Center-Elyria
- Cleveland Clinic Cancer Center Independence
- Cleveland Clinic Cancer Center Mansfield
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- UH Seidman Cancer Center at Southwest General Hospital
- University Hospitals Parma Medical Center
- North Coast Cancer Care
- UH Seidman Cancer Center at Firelands Regional Medical Center
- Cleveland Clinic Cancer Center Strongsville
- ProMedica Flower Hospital
- UHHS-Westlake Medical Center
- Cleveland Clinic Wooster Family Health and Surgery Center
- University of Oklahoma Health Sciences Center
- Abington Memorial Hospital
- Crozer-Keystone Regional Cancer Center at Broomall
- Christiana Care Health System-Concord Health Center
- Geisinger Medical Center
- Northeast Radiation Oncology Center
- Crozer Regional Cancer Center at Brinton Lake
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- Thomas Jefferson University Hospital
- Guthrie Medical Group PC-Robert Packer Hospital
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South Carolina
- Prisma Health Cancer Institute - Faris
- Saint Francis Cancer Center
- Prisma Health Cancer Institute - Eastside
- Self Regional Healthcare
- Gibbs Cancer Center-Pelham
- The Radiation Oncology Center-Hilton Head/Bluffton
- Carolina Regional Cancer Center
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical Center
- Vanderbilt University/Ingram Cancer Center
- UT Southwestern/Simmons Cancer Center-Dallas
- University of Texas Medical Branch
- UTMB Cancer Center at Victory Lakes
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Farmington Health Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Ogden Regional Medical Center
- Utah Valley Regional Medical Center
- Riverton Hospital
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- South Jordan Health Center
- Norris Cotton Cancer Center-North
- Augusta Health Center for Cancer and Blood Disorders
- Naval Medical Center - Portsmouth
- Overlake Medical Center
- Ascension Saint Elizabeth Hospital
- Ascension Southeast Wisconsin Hospital - Elmbrook Campus
- Mayo Clinic Health System Eau Claire Hospital-Luther Campus
- Ascension Saint Francis - Reiman Cancer Center
- Aurora Cancer Care-Grafton
- Aurora BayCare Medical Center
- Aurora Cancer Care-Kenosha South
- Gundersen Lutheran Medical Center
- Mayo Clinic Health System-Franciscan Healthcare
- University of Wisconsin Hospital and Clinics
- Aurora Bay Area Medical Group-Marinette
- Froedtert Menomonee Falls Hospital
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Zablocki Veterans Administration Medical Center
- Ascension Mercy Hospital
- Vince Lombardi Cancer Clinic - Oshkosh
- Ascension All Saints Hospital
- Vince Lombardi Cancer Clinic-Sheboygan
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora West Allis Medical Center
- Froedtert West Bend Hospital/Kraemer Cancer Center
- Aspirus Cancer Care - Wisconsin Rapids
- Tom Baker Cancer Centre
- Juravinski Cancer Centre at Hamilton Health Sciences
- London Regional Cancer Program
- Centre De Sante Et De Services Sociaux De Chicoutimi
- CIUSSSEMTL-Hopital Maisonneuve-Rosemont
- CHUM - Centre Hospitalier de l'Universite de Montreal
- The Research Institute of the McGill University Health Centre (MUHC)
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
- Kantonsspital Aarau
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Conventional radiation therapy
Hypofractionated radiation therapy
Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation.
Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation.