RECRUITING

Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer

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Conditions

Stage III Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.

Official Title

The Phase III 'High Five Trial' Five Fraction Radiation for High-Risk Prostate Cancer

Quick Facts

Study Start:2023-11-13
Study Completion:2041-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05946213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
  2. * High-risk disease defined as having at least one or more of the following:
  3. * cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer \[AJCC\] 8th edition \[Ed.\]) Note: cT4 by imaging or on digital rectal exam is not allowed
  4. * The patient's prostate specific antigen (PSA) \> 20 ng/mL prior to starting ADT Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible. The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors
  5. * Gleason Score of 8-10
  6. * Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm
  7. * Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or computed tomography (CT) scan
  8. * No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute
  9. * Age \>= 18
  10. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  11. * No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  12. * No prior radical prostatectomy
  13. * Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone \[LHRH\] agonist and oral anti-androgen) is =\< 185 days prior to registration
  14. * Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Karen E Hoffman
PRINCIPAL_INVESTIGATOR
NRG Oncology

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
United States
Lewis and Faye Manderson Cancer Center
Tuscaloosa, Alabama, 35401
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211
United States
Kaiser Permanente Dublin
Dublin, California, 94568
United States
Kaiser Permanente-Fremont
Fremont, California, 94538
United States
Fresno Cancer Center
Fresno, California, 93720
United States
Kaiser Permanente-Fresno
Fresno, California, 93720
United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Kaiser Permanente-Modesto
Modesto, California, 95356
United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611
United States
Kaiser Permanente-Oakland
Oakland, California, 94611
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670
United States
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, 94063
United States
Kaiser Permanente-Richmond
Richmond, California, 94801
United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928
United States
Kaiser Permanente-Roseville
Roseville, California, 95661
United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678
United States
Kaiser Permanente Downtown Commons
Sacramento, California, 95814
United States
Kaiser Permanente-South Sacramento
Sacramento, California, 95823
United States
South Sacramento Cancer Center
Sacramento, California, 95823
United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115
United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119
United States
Kaiser Permanente San Leandro
San Leandro, California, 94577
United States
Kaiser San Rafael-Gallinas
San Rafael, California, 94903
United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403
United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080
United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080
United States
Kaiser Permanente-Stockton
Stockton, California, 95210
United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688
United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589
United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596
United States
Helen F Graham Cancer Center
Newark, Delaware, 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
United States
George Washington University Medical Center
Washington, District of Columbia, 20037
United States
Jupiter Medical Center
Jupiter, Florida, 33458
United States
Grady Health System
Atlanta, Georgia, 30303
United States
Emory Proton Therapy Center
Atlanta, Georgia, 30308
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
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Illinois
Chicago, Illinois, 60612
United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Advocate Sherman Hospital
Elgin, Illinois, 60123
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
United States
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
United States
Condell Memorial Hospital
Libertyville, Illinois, 60048
United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
United States
Advocate High Tech Medical Park
Palos Heights, Illinois, 60463
United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
United States
Illinois CancerCare-Peru
Peru, Illinois, 61354
United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
United States
Memorial Hospital East
Shiloh, Illinois, 62269
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Springfield Memorial Hospital
Springfield, Illinois, 62781
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526
United States
McFarland Clinic - Ames
Ames, Iowa, 50010
United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214
United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
United States
MaineHealth Coastal Cancer Treatment Center
Bath, Maine, 04530
United States
Maine Medical Center-Bramhall Campus
Portland, Maine, 04102
United States
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073
United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074
United States
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061
United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
United States
Chelsea Hospital
Chelsea, Michigan, 48118
United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124
United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
United States
Hurley Medical Center
Flint, Michigan, 48503
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601
United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
United States
Munson Medical Center
Traverse City, Michigan, 49684
United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085
United States
University of Michigan Health - West
Wyoming, Michigan, 49519
United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
United States
Saint Luke's Hospital of Duluth
Duluth, Minnesota, 55805
United States
Fairview Southdale Hospital
Edina, Minnesota, 55435
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
Lakeview Hospital
Stillwater, Minnesota, 55082
United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Siteman Cancer Center-South County
Saint Louis, Missouri, 63129
United States
Missouri Baptist Medical Center
Saint Louis, Missouri, 63131
United States
Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri, 63136
United States
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri, 63376
United States
Billings Clinic Cancer Center
Billings, Montana, 59101
United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
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
Stony Brook University Medical Center
Stony Brook, New York, 11794
United States
Westchester Medical Center
Valhalla, New York, 10595
United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
United States
Altru Cancer Center
Grand Forks, North Dakota, 58201
United States
Cleveland Clinic Akron General
Akron, Ohio, 44307
United States
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011
United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
United States
Aultman Health Foundation
Canton, Ohio, 44710
United States
Case Western Reserve University
Cleveland, Ohio, 44106
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Riverside Methodist Hospital
Columbus, Ohio, 43214
United States
Grant Medical Center
Columbus, Ohio, 43215
United States
Doctors Hospital
Columbus, Ohio, 43228
United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
United States
Grady Memorial Hospital
Delaware, Ohio, 43015
United States
Dublin Methodist Hospital
Dublin, Ohio, 43016
United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903
United States
OhioHealth Marion General Hospital
Marion, Ohio, 43302
United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Saint Charles Health System
Bend, Oregon, 97701
United States
Kaiser Permanente Northwest
Portland, Oregon, 97227
United States
Carlisle Regional Cancer Center
Carlisle, Pennsylvania, 17015
United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050
United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
United States
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243
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
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
United States
MGC Hematology Oncology-Union
Union, South Carolina, 29379
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
United States
MD Anderson in The Woodlands
Conroe, Texas, 77384
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
MD Anderson West Houston
Houston, Texas, 77079
United States
MD Anderson League City
League City, Texas, 77573
United States
MD Anderson in Sugar Land
Sugar Land, Texas, 77478
United States
Farmington Health Center
Farmington, Utah, 84025
United States
University of Utah Sugarhouse Health Center
Salt Lake City, Utah, 84106
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont, 05602
United States
University of Vermont Medical Center
Burlington, Vermont, 05401
United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
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
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701
United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
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
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
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
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
United States
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501
United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241
United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226
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

Collaborators and Investigators

Sponsor: NRG Oncology

  • Karen E Hoffman, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-13
Study Completion Date2041-03-31

Study Record Updates

Study Start Date2023-11-13
Study Completion Date2041-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Stage III Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8