Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer
Phase III IGRT and SBRT vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer
3 other identifiers
interventional
692
6 countries
293
Brief Summary
This randomized phase III trial studies how well stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Stereotactic body radiation therapy 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 P75+ for phase_3
Started Feb 2018
Longer than P75 for phase_3
293 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
First Submitted
Initial submission to the registry
December 5, 2017
CompletedFirst Posted
Study publicly available on registry
December 11, 2017
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
January 15, 2026
January 1, 2026
9.8 years
December 5, 2017
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of patients-reported gastrointestinal and genitourinary toxicity
Will be measured by Expanded Prostate Cancer Index Composite-(EPIC) 26 bowel and urinary irritation domains. Will be compared between treatment arms using a test of proportions with two-sided significance level of 0.05.
Up to 2 years
Disease free survival
Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test.
Time to biochemical failure (Phoenix definition), local failure, regional failure, distant metastasis, or death from any cause, assessed up to 2 years
Secondary Outcomes (10)
Health related quality of life
Up to 2 years
Biochemical failure
Up to 2 years
Local failure
From the time of randomization to the date of local failure, date of precluding death, or last known follow-up date, assessed for up to 2 years
Regional failure
From the time of randomization to the date of local failure, date of precluding death, or last known follow-up date, assessed for up to 2 years
Distant metastasis
From the time of randomization to the date of distant metastasis, date of precluding death, or last known follow-up date, assessed for up to 2 years
- +5 more secondary outcomes
Other Outcomes (6)
Central manual user segmentation of tumors
Up to 2 years
Performance of supervised automated tumor detection toolset
Up to 2 years
Performance of supervised automated tumor segmentation toolset
Up to 5 years
- +3 more other outcomes
Study Arms (2)
Arm I (IMRT)
ACTIVE COMPARATORPatients undergo IMRT once daily for 5 fractions per week for 20 or 28 fractions over less than 32 business days.
Arm II (SBRT)
EXPERIMENTALPatients undergo SBRT at least every other day for 2-3 fractions per week over less than 17 business days.
Interventions
Undergo IMRT
Ancillary studies
Undergo SBRT
Eligibility Criteria
You may qualify if:
- Previously untreated (no local therapy such as surgery, radiation cryotherapy, high-intensity focused ultrasound \[HIFU\], etc.) localized adenocarcinoma of the prostate with the following clinical findings:
- Clinical stage by digital rectal exam of either T1c or T2a/b (limited to one side of the gland); (American Joint Committee on Cancer \[AJCC\], version 7) or cT1a-c or 2a or 2b
- Stages T1a-T1b are eligible if patient underwent transurethral prostatic resection (TURP)
- The patient must meet one of the following 3 criteria: 1) Gleason score must be Gleason 7(3+4) with a PSA \< 20 ng/mL, or 2) Gleason 6 (3+3) with a PSA \> 10 ng/mL and \< 20 ng/mL which is considered intermediate risk and eligible for the study (AJCC, version 7), or 3) Group Grade 1 with a PSA \> 10 ng/mL and \< 20 ng/mL or 2 with a PSA \< 20 ng/mL
- If patient is receiving a 5-alpha reductase inhibitor at the time of enrollment, the baseline PSA value may be double the initial value and the medication should be discontinued but a washout period is not required; to be eligible, a PSA drawn while still on the medicine must be:
- \< 10 ng/mL if Gleason 7(3+4) (note this patient would be on stratification level 1 if PSA \< 5 ng/mL and stratification level 2 if less than 10 ng/mL)
- \> 5 ng/mL and less than 10 ng/mL for Gleason 6(3+3) (note this patient would be on stratification level 3)
- The prostate volume must be \< 70 cc as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including magnetic resonance imaging (MRI) or computed tomography (CT) scan
- Patients in active surveillance who elect to be treated are eligible if they meet protocol requirements
- Age \>= 18
- History and physical including a digital rectal exam 60 days prior to registration
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 60 days prior to registration
- MRI of the prostate and pelvis (per institutional standard of care \[SOC\] - should be compliant with PIRADSv2.1 guidelines) within 1 year prior to registration
- Bone scan as clinically indicated within 120 days prior to registration
- Charlson modified co-morbidity score =\< 4 for patients under 60 and =\< 5 for patients 60 and over 21 days prior to registration
- +5 more criteria
You may not qualify if:
- Definitive clinical or radiologic evidence of metastatic disease; no nodal involvement or evidence of metastatic disease allowed as defined by screening of the pelvis
- Definitive T3 disease on MRI
- Prior or current invasive malignancy with current evidence of active disease within the past 2 years
- Exceptions: Non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; must be off treatment for at least 3 years
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- The use of hormonal therapy is not allowed; if the patient is on a 5-alpha reductase inhibitor, then they should be stopped prior to treatment once enrolled onto the study; no washout period is required for this study to participate
- Severe, active co-morbidity defined as follows:
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; (patients on Coumadin or other blood thinning agents are eligible for this study)
- Contraindication to MRI
- Cardiac pacemaker or defibrillator
- Surgically implanted electrical devices such as spinal stimulation devices or intracranial stimulation devices, cochlear implants, the presence of metallic foreign bodies in the orbits, and incompatible old mechanical heart valves and aneurysm clips
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (293)
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
Lewis and Faye Manderson Cancer Center
Tuscaloosa, Alabama, 35401, United States
Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona, 85297, United States
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, 85381, United States
Arizona Center for Cancer Care - Scottsdale
Scottsdale, Arizona, 85258, United States
Arizona Center for Cancer Care-Surprise
Surprise, Arizona, 85374, United States
Arizona Oncology Associates-West Orange Grove
Tucson, Arizona, 85704, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Kaiser Permanente-Anaheim
Anaheim, California, 92806, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Mercy Cancer Center - Carmichael
Carmichael, California, 95608, United States
Mercy San Juan Medical Center
Carmichael, California, 95608, United States
Kaiser Permanente Dublin
Dublin, California, 94568, United States
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758, United States
Fresno Cancer Center
Fresno, California, 93720, United States
Marin General Hospital
Greenbrae, California, 94904, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, 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
Memorial Medical Center
Modesto, California, 95355, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611, United States
Saint Joseph Hospital - Orange
Orange, California, 92868, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670, United States
Mercy Cancer Center - Rocklin
Rocklin, California, 95765, United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678, United States
Mercy Cancer Center - Sacramento
Sacramento, California, 95816, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Salinas Valley Memorial
Salinas, California, 93901, United States
Stanford Cancer Center South Bay
San Jose, California, 95124, 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
Woodland Memorial Hospital
Woodland, California, 95695, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
AdventHealth Porter
Denver, Colorado, 80210, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Valley View Hospital Cancer Center
Glenwood Springs, Colorado, 81601, United States
AdventHealth Littleton
Littleton, Colorado, 80122, United States
AdventHealth Parker
Parker, Colorado, 80138, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437, United States
Yale University
New Haven, Connecticut, 06520, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385, United States
Beebe South Coastal Health Campus
Millville, Delaware, 19967, 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
John Fitzgerald Kennedy Medical Center
Atlantis, Florida, 33462, United States
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180, United States
Broward Health North
Deerfield Beach, Florida, 33064, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
GenesisCare USA - Key West
Key West, Florida, 33040, United States
GenesisCare USA - Lakewood Ranch
Lakewood Rch, Florida, 34202, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
GenesisCare USA - Plantation
Plantation, Florida, 33324, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, 30214, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687, United States
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Edward Hines Jr VA Hospital
Hines, Illinois, 60141, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Midwestern Regional Medical Center
Zion, Illinois, 60099, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805, United States
Parkview Regional Medical Center
Fort Wayne, Indiana, 46845, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
Franciscan Health Mooresville
Mooresville, Indiana, 46158, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
MaineHealth Coastal Cancer Treatment Center
Bath, Maine, 04530, United States
MaineHealth Maine Medical Center - Portland
Portland, Maine, 04102, United States
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073, United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074, United States
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Saint Agnes Hospital
Baltimore, Maryland, 21229, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044, United States
University of Maryland Shore Medical Center at Easton
Easton, Maryland, 21601, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
TidalHealth Richard A Henson Cancer Institute
Ocean Pines, Maryland, 21811, United States
TidalHealth Peninsula Regional
Salisbury, Maryland, 21801, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
McLaren Cancer Institute-Bay City
Bay City, Michigan, 48706, United States
McLaren Cancer Institute-Clarkston
Clarkston, Michigan, 48346, United States
Michigan Healthcare Professionals Clarkston
Clarkston, Michigan, 48346, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Michigan Healthcare Professionals Farmington
Farmington Hills, Michigan, 48334, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan, 48336, 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
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
Michigan Healthcare Professionals Macomb
Macomb, Michigan, 48044, United States
Michigan Healthcare Professionals Madison Heights
Madison Heights, Michigan, 48071, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, 48043, United States
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, 49770, United States
McLaren-Port Huron
Port Huron, Michigan, 48060, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085, United States
Michigan Healthcare Professionals Troy
Troy, Michigan, 48098, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703, United States
Saint Francis Medical Center
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
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63104, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Logan Health Medical Center
Kalispell, Montana, 59901, United States
Community Medical Center
Missoula, Montana, 59804, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Exeter Hospital
Exeter, New Hampshire, 03833, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, 07652, United States
Capital Health Medical Center-Hopewell
Pennington, New Jersey, 08534, 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
Saint Peter's Health Partners
Albany, New York, 12208, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Sands Cancer Center
Canandaigua, New York, 14424, United States
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
Garnet Health Medical Center
Middletown, New York, 10940, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Highland Hospital
Rochester, New York, 14620, United States
University of Rochester
Rochester, New York, 14642, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Scotland Memorial Hospital-Laurinburg Cancer Center
Laurinburg, North Carolina, 28352, United States
Duke Cancer Center Raleigh
Raleigh, North Carolina, 27609, 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
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, 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
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, 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
University Hospitals Portage Medical Center
Ravenna, Ohio, 44266, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, 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
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
East Norriton, Pennsylvania, 19401, United States
Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania, 18925, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
WellSpan Health-York Cancer Center
York, Pennsylvania, 17403, 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
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, 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
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Texas Cancer Center
Abilene, Texas, 79606, United States
Texas Oncology-McKinney
McKinney, Texas, 75071, United States
Texas Oncology-Plano West
Plano, Texas, 75093, United States
Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, 77479, United States
Deke Slayton Cancer Center
Webster, Texas, 77598, 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
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Saint George Regional Medical Center
St. George, Utah, 84770, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819, United States
Sentara Cancer Institute at Sentara CarePlex Hospital
Hampton, Virginia, 23666, United States
Bon Secours DePaul Medical Center
Norfolk, Virginia, 23505, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230, United States
Oncology and Hematology Associates of Southwest Virginia
Roanoke, Virginia, 24014, United States
Sentara Obici Hospital
Suffolk, Virginia, 23434, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362, United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, 54915, United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045, United States
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, 53132, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, 53097, United States
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, 53211, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, 53295, United States
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154, 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
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095, United States
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, K1H 8L6, 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
Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong
Tata Memorial Hospital
Mumbai, 400 012, India
Beacon Hospital
Dublin, Co Dublin, 18, Ireland
Saint Lukes Hospital
Dublin, Co Dublin, 6, Ireland
Kantonsspital Aarau
Aarau, 5001, Switzerland
Related Publications (2)
Alley S, Tonneau M, Olivie D, Tempany-Afdhal CM, Choyke PL, Turkbey IB, van der Heide UA, Ellis RJ, Kadoury S, Boike TP, Pennington JD, Frazier A, Lawton CAF, Leong N, Mihai AM, Morgan SC, Solanki AA, Michalski JM, Feng FY, Sandler HM, Menard C. Assessing Quality and Adherence to PI-RADSv2.1 Minimum Technical Standards of Prostate MRI in NRG-GU005. J Magn Reson Imaging. 2026 Feb;63(2):464-474. doi: 10.1002/jmri.70142. Epub 2025 Oct 8.
PMID: 41063518DERIVEDAlley S, Jackson E, Olivie D, Van der Heide UA, Menard C, Kadoury S. Effect of magnetic resonance imaging pre-processing on the performance of model-based prostate tumor probability mapping. Phys Med Biol. 2022 Dec 13;67(24). doi: 10.1088/1361-6560/ac99b4.
PMID: 36223780DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rodney J Ellis
NRG Oncology
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
December 5, 2017
First Posted
December 11, 2017
Study Start
February 1, 2018
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
January 15, 2026
Record last verified: 2026-01