Hypofractionated Radiation Therapy or Conventional Radiation Therapy After Surgery in Treating Patients With Prostate Cancer
A Randomized Phase III Trial of Hypofractionated Post-Prostatectomy Radiation Therapy (HYPORT) Versus Conventional Post-Prostatectomy Radiation Therapy (COPORT)
3 other identifiers
interventional
296
3 countries
241
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2017
Longer than P75 for phase_3
241 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 28, 2017
CompletedFirst Submitted
Initial submission to the registry
September 5, 2017
CompletedFirst Posted
Study publicly available on registry
September 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2021
CompletedResults Posted
Study results publicly available
June 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2025
CompletedJuly 9, 2026
June 1, 2026
3.6 years
September 5, 2017
May 10, 2022
June 22, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Baseline (randomization), 2 years
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.
Baseline, 2 years
Secondary Outcomes (10)
Change in Urinary Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of Radiation Therapy (RT), 6 Months, 1 and 5 Years
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.
Change in Bowel Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of RT, 6 Months, 1 and 5 Years
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.
Percentage of Participants With Biochemical Failure
From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years.
Percentage of Participants With Progression
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.
Percentage of Participants With Local-Regional Failure
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 more secondary outcomes
Other Outcomes (2)
Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years by Ethnicity
Baseline (randomization), 2 years
Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years by Race
Baseline (randomization), 2 years
Study Arms (2)
Arm I (conventional radiation therapy)
EXPERIMENTALPatients 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 (hypofractionated radiation therapy
EXPERIMENTALPatients 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.
Interventions
Ancillary studies
Undergo conventional radiation therapy
Correlative studies
Undergo hypofractionated radiation therapy
Eligibility Criteria
You may qualify if:
- 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
- +7 more criteria
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (241)
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
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128, United States
The University of Kansas Cancer Center-South
Kansas City, Missouri, 64131, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Logan Health Medical Center
Kalispell, Montana, 59901, United States
Wentworth-Douglass Hospital
Dover, New Hampshire, 03820, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Lovelace Radiation Oncology
Albuquerque, New Mexico, 87109, United States
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109, United States
Memorial Medical Center-Las Cruces
Las Cruces, New Mexico, 88011, United States
Northwell Health Imbert Cancer Center
Bay Shore, New York, 11706, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York, 14905, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
Dickstein Cancer Treatment Center
White Plains, New York, 10601, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
UNC Health Cancer Care Raleigh
Raleigh, North Carolina, 27607, United States
Novant Cancer Institute Radiation Oncology - Supply
Supply, North Carolina, 28462, United States
Novant Health Cancer Institute Radiation Oncology - Wilmington
Wilmington, North Carolina, 28401, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Geauga Hospital
Chardon, Ohio, 44024, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035, United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio, 44131, United States
Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio, 44906, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio, 44130, United States
University Hospitals Parma Medical Center
Parma, Ohio, 44129, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, 44870, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, 44136, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, United States
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, 44691, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Jefferson Abington Hospital
Abington, Pennsylvania, 19001, United States
Crozer-Keystone Regional Cancer Center at Broomall
Broomall, Pennsylvania, 19008, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512, United States
Crozer Regional Cancer Center at Brinton Lake
Glen Mills, Pennsylvania, 19342, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
The Radiation Oncology Center-Hilton Head/Bluffton
Hilton Head Island, South Carolina, 29926, United States
Carolina Regional Cancer Center
Myrtle Beach, South Carolina, 29577, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
UTMB Cancer Center at Victory Lakes
League City, Texas, 77573, United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003, United States
Farmington Health Center
Farmington, Utah, 84025, United States
Logan Regional Hospital
Logan, Utah, 84321, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Ogden Regional Medical Center
Ogden, Utah, 84405, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Riverton Hospital
Riverton, Utah, 84065, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
South Jordan Health Center
South Jordan, Utah, 84009, United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819, United States
Augusta Health Center for Cancer and Blood Disorders
Fishersville, Virginia, 22939, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, 23708-2197, United States
Overlake Medical Center
Bellevue, Washington, 98004, United States
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, 54915, United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045, United States
Mayo Clinic Health System Eau Claire Hospital-Luther Campus
Eau Claire, Wisconsin, 54703, United States
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, 53132, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, 53295, United States
Ascension Mercy Hospital
Oshkosh, Wisconsin, 54904, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Ascension All Saints Hospital
Racine, Wisconsin, 53405, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Centre De Sante Et De Services Sociaux De Chicoutimi
Chicoutimi, Quebec, G7H 5H6, Canada
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, H3H 2R9, Canada
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec, G1R 2J6, Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Kantonsspital Aarau
Aarau, 5001, Switzerland
Related Publications (1)
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.
PMID: 38483412DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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.
Results Point of Contact
- Title
- Wendy Seiferheld
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Mark K Buyyounouski
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2017
First Posted
September 7, 2017
Study Start
July 28, 2017
Primary Completion
February 22, 2021
Study Completion
December 23, 2025
Last Updated
July 9, 2026
Results First Posted
June 6, 2022
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
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.