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COMPLETED

NCT03274687

PHASE3

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

Sponsor: NRG Oncology

View on ClinicalTrials.gov

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.

Official title: A Randomized Phase III Trial of Hypofractionated Post-Prostatectomy Radiation Therapy (HYPORT) Versus Conventional Post-Prostatectomy Radiation Therapy (COPORT)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

296

Start Date

2017-07-28

Completion Date

2025-12-23

Last Updated

2026-07-09

Healthy Volunteers

Conditions

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

Interventions

RADIATION

Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Quality-of-Life Assessment

Ancillary studies

RADIATION

Radiation Therapy

Undergo conventional radiation therapy

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: * 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

Locations (241)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Marin Cancer Care Inc

Greenbrae, California, United States

Marin General Hospital

Greenbrae, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Pomona Valley Hospital Medical Center

Pomona, California, United States

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Rohnert Park Cancer Center

Rohnert Park, California, United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

South Sacramento Cancer Center

Sacramento, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Yale University

New Haven, Connecticut, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

TidalHealth Nanticoke / Allen Cancer Center

Seaford, Delaware, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Cleveland Clinic-Weston

Weston, Florida, United States

Grady Health System

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Queen's Medical Center

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Pali Momi

‘Aiea, Hawaii, United States

SIH Cancer Institute

Carterville, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Goshen Center for Cancer Care

Goshen, Indiana, United States

McFarland Clinic - Ames

Ames, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

The University of Kansas Cancer Center - Olathe

Olathe, Kansas, United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

Cotton O'Neil Cancer Center / Stormont Vail Health

Topeka, Kansas, United States

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Owensboro Health Mitchell Memorial Cancer Center

Owensboro, Kentucky, United States

East Jefferson General Hospital

Metairie, Louisiana, United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

MaineHealth Maine Medical Center - Portland

Portland, Maine, United States

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, United States

University of Maryland Radiation Oncology Center at Union Hospital

Elkton, Maryland, United States

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Lowell General Hospital

Lowell, Massachusetts, United States

Beth Israel Deaconess Hospital-Plymouth

Plymouth, Massachusetts, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

McLaren Cancer Institute-Clarkston

Clarkston, Michigan, United States

Michigan Healthcare Professionals Clarkston

Clarkston, Michigan, United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Michigan Healthcare Professionals Farmington

Farmington Hills, Michigan, United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, United States

McLaren Cancer Institute-Central Michigan

Mount Pleasant, Michigan, United States

McLaren Cancer Institute-Owosso

Owosso, Michigan, United States

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

McLaren-Port Huron

Port Huron, Michigan, United States

Michigan Healthcare Professionals Troy

Troy, Michigan, United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

University of Michigan Health - West

Wyoming, Michigan, United States

Saint Luke's Hospital of Duluth

Duluth, Minnesota, United States

And 141 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (241)