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

NCT ID: NCT03274687

Last Updated: 2026-01-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-28

Study Completion Date

2026-08-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Radiation Therapy

Intervention Type RADIATION

Undergo conventional radiation therapy

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.

Group Type EXPERIMENTAL

Hypofractionated Radiation Therapy

Intervention Type RADIATION

Undergo hypofractionated radiation therapy

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

Intervention Type RADIATION

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Radiation Therapy

Undergo conventional radiation therapy

Intervention Type RADIATION

Other Intervention Names

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Hypofractionated Hypofractionated Radiotherapy hypofractionation Radiation, Hypofractionated Quality of Life Assessment Cancer Radiotherapy Energy Type ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

NRG Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark K Buyyounouski

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Marin Cancer Care Inc

Greenbrae, California, United States

Site Status

Marin General Hospital

Greenbrae, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Los Angeles General Medical Center

Los Angeles, California, United States

Site Status

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

Fremont - Rideout Cancer Center

Marysville, California, United States

Site Status

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Site Status

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Site Status

Pomona Valley Hospital Medical Center

Pomona, California, United States

Site Status

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Site Status

Rohnert Park Cancer Center

Rohnert Park, California, United States

Site Status

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Site Status

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

South Sacramento Cancer Center

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Site Status

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

Site Status

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status

TidalHealth Nanticoke / Allen Cancer Center

Seaford, Delaware, United States

Site Status

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

Site Status

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status

Cleveland Clinic-Weston

Weston, Florida, United States

Site Status

Grady Health System

Atlanta, Georgia, United States

Site Status

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status

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

Savannah, Georgia, United States

Site Status

Queen's Medical Center

Honolulu, Hawaii, United States

Site Status

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Site Status

The Cancer Center of Hawaii-Pali Momi

‘Aiea, Hawaii, United States

Site Status

SIH Cancer Institute

Carterville, Illinois, United States

Site Status

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

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Decatur Memorial Hospital

Decatur, Illinois, United States

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Crossroads Cancer Center

Effingham, Illinois, United States

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Loyola University Medical Center

Maywood, Illinois, United States

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UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

Site Status

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, United States

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OSF Saint Francis Medical Center

Peoria, Illinois, United States

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UW Health Carbone Cancer Center Rockford

Rockford, Illinois, United States

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Carle Cancer Center

Urbana, Illinois, United States

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Goshen Center for Cancer Care

Goshen, Indiana, United States

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McFarland Clinic - Ames

Ames, Iowa, United States

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Iowa Methodist Medical Center

Des Moines, Iowa, United States

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University of Kansas Cancer Center

Kansas City, Kansas, United States

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The University of Kansas Cancer Center - Olathe

Olathe, Kansas, United States

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University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

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Cotton O'Neil Cancer Center / Stormont Vail Health

Topeka, Kansas, United States

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Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

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Owensboro Health Mitchell Memorial Cancer Center

Owensboro, Kentucky, United States

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East Jefferson General Hospital

Metairie, Louisiana, United States

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Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

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MaineHealth Maine Medical Center - Portland

Portland, Maine, United States

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MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, United States

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University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

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Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, United States

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University of Maryland Radiation Oncology Center at Union Hospital

Elkton, Maryland, United States

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UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, United States

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Boston Medical Center

Boston, Massachusetts, United States

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Lowell General Hospital

Lowell, Massachusetts, United States

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Beth Israel Deaconess Hospital-Plymouth

Plymouth, Massachusetts, United States

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Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

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Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

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McLaren Cancer Institute-Clarkston

Clarkston, Michigan, United States

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Michigan Healthcare Professionals Clarkston

Clarkston, Michigan, United States

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Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

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Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Michigan Healthcare Professionals Farmington

Farmington Hills, Michigan, United States

Site Status

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Site Status

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Site Status

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

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Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

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West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

Site Status

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

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McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

Site Status

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

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McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, United States

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McLaren Cancer Institute-Central Michigan

Mount Pleasant, Michigan, United States

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McLaren Cancer Institute-Owosso

Owosso, Michigan, United States

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McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, United States

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Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

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McLaren-Port Huron

Port Huron, Michigan, United States

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Michigan Healthcare Professionals Troy

Troy, Michigan, United States

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Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

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University of Michigan Health - West

Wyoming, Michigan, United States

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Saint Luke's Hospital of Duluth

Duluth, Minnesota, United States

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Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Site Status

Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, United States

Site Status

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status

North Kansas City Hospital

Kansas City, Missouri, United States

Site Status

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, United States

Site Status

The University of Kansas Cancer Center-South

Kansas City, Missouri, United States

Site Status

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

Site Status

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

Site Status

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Siteman Cancer Center-South County

St Louis, Missouri, United States

Site Status

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

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Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Site Status

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

Logan Health Medical Center

Kalispell, Montana, United States

Site Status

Wentworth-Douglass Hospital

Dover, New Hampshire, United States

Site Status

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Site Status

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status

Lovelace Radiation Oncology

Albuquerque, New Mexico, United States

Site Status

New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, United States

Site Status

Memorial Medical Center-Las Cruces

Las Cruces, New Mexico, United States

Site Status

Northwell Health Imbert Cancer Center

Bay Shore, New York, United States

Site Status

New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Mary Imogene Bassett Hospital

Cooperstown, New York, United States

Site Status

Arnot Ogden Medical Center/Falck Cancer Center

Elmira, New York, United States

Site Status

Northwell Health/Center for Advanced Medicine

Lake Success, New York, United States

Site Status

NYP/Weill Cornell Medical Center

New York, New York, United States

Site Status

Dickstein Cancer Treatment Center

White Plains, New York, United States

Site Status

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

UNC Health Cancer Care Raleigh

Raleigh, North Carolina, United States

Site Status

Novant Cancer Institute Radiation Oncology - Supply

Supply, North Carolina, United States

Site Status

Novant Health Cancer Institute Radiation Oncology - Wilmington

Wilmington, North Carolina, United States

Site Status

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic Akron General

Akron, Ohio, United States

Site Status

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States

Site Status

Geauga Hospital

Chardon, Ohio, United States

Site Status

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Mercy Cancer Center-Elyria

Elyria, Ohio, United States

Site Status

Cleveland Clinic Cancer Center Independence

Independence, Ohio, United States

Site Status

Cleveland Clinic Cancer Center Mansfield

Mansfield, Ohio, United States

Site Status

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States

Site Status

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States

Site Status

UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, United States

Site Status

University Hospitals Parma Medical Center

Parma, Ohio, United States

Site Status

North Coast Cancer Care

Sandusky, Ohio, United States

Site Status

UH Seidman Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, United States

Site Status

Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, United States

Site Status

ProMedica Flower Hospital

Sylvania, Ohio, United States

Site Status

UHHS-Westlake Medical Center

Westlake, Ohio, United States

Site Status

Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Jefferson Abington Hospital

Abington, Pennsylvania, United States

Site Status

Crozer-Keystone Regional Cancer Center at Broomall

Broomall, Pennsylvania, United States

Site Status

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Northeast Radiation Oncology Center

Dunmore, Pennsylvania, United States

Site Status

Crozer Regional Cancer Center at Brinton Lake

Glen Mills, Pennsylvania, United States

Site Status

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Guthrie Medical Group PC-Robert Packer Hospital

Sayre, Pennsylvania, United States

Site Status

Reading Hospital

West Reading, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Site Status

Saint Francis Cancer Center

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Site Status

Self Regional Healthcare

Greenwood, South Carolina, United States

Site Status

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

Site Status

The Radiation Oncology Center-Hilton Head/Bluffton

Hilton Head Island, South Carolina, United States

Site Status

Carolina Regional Cancer Center

Myrtle Beach, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Site Status

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Site Status

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

UTMB Cancer Center at Victory Lakes

League City, Texas, United States

Site Status

American Fork Hospital / Huntsman Intermountain Cancer Center

American Fork, Utah, United States

Site Status

Farmington Health Center

Farmington, Utah, United States

Site Status

Logan Regional Hospital

Logan, Utah, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

McKay-Dee Hospital Center

Ogden, Utah, United States

Site Status

Ogden Regional Medical Center

Ogden, Utah, United States

Site Status

Utah Valley Regional Medical Center

Provo, Utah, United States

Site Status

Riverton Hospital

Riverton, Utah, United States

Site Status

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, United States

Site Status

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status

LDS Hospital

Salt Lake City, Utah, United States

Site Status

South Jordan Health Center

South Jordan, Utah, United States

Site Status

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, United States

Site Status

Augusta Health Center for Cancer and Blood Disorders

Fishersville, Virginia, United States

Site Status

Naval Medical Center - Portsmouth

Portsmouth, Virginia, United States

Site Status

Overlake Medical Center

Bellevue, Washington, United States

Site Status

Ascension Saint Elizabeth Hospital

Appleton, Wisconsin, United States

Site Status

Ascension Southeast Wisconsin Hospital - Elmbrook Campus

Brookfield, Wisconsin, United States

Site Status

Mayo Clinic Health System Eau Claire Hospital-Luther Campus

Eau Claire, Wisconsin, United States

Site Status

Ascension Saint Francis - Reiman Cancer Center

Franklin, Wisconsin, United States

Site Status

Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States

Site Status

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Site Status

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, United States

Site Status

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States

Site Status

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Site Status

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, United States

Site Status

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States

Site Status

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Site Status

Zablocki Veterans Administration Medical Center

Milwaukee, Wisconsin, United States

Site Status

Ascension Mercy Hospital

Oshkosh, Wisconsin, United States

Site Status

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, United States

Site Status

Ascension All Saints Hospital

Racine, Wisconsin, United States

Site Status

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, United States

Site Status

Aurora Medical Center in Summit

Summit, Wisconsin, United States

Site Status

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, United States

Site Status

Aurora West Allis Medical Center

West Allis, Wisconsin, United States

Site Status

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, United States

Site Status

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, United States

Site Status

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Site Status

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

London Regional Cancer Program

London, Ontario, Canada

Site Status

Centre De Sante Et De Services Sociaux De Chicoutimi

Chicoutimi, Quebec, Canada

Site Status

CIUSSSEMTL-Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Site Status

The Research Institute of the McGill University Health Centre (MUHC)

Montreal, Quebec, Canada

Site Status

CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

Québec, Quebec, Canada

Site Status

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, Canada

Site Status

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Site Status

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Site Status

Kantonsspital Aarau

Aarau, , Switzerland

Site Status

Countries

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United States Canada Switzerland

References

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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.

Reference Type DERIVED
PMID: 38483412 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2016-01771

Identifier Type: REGISTRY

Identifier Source: secondary_id

NRG-GU003

Identifier Type: -

Identifier Source: secondary_id

NRG-GU003

Identifier Type: OTHER

Identifier Source: secondary_id

NRG-GU003

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NRG-GU003

Identifier Type: -

Identifier Source: org_study_id

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