Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer

January 13, 2026 updated by: NRG Oncology

Phase III IGRT and SBRT vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether stereotactic body radiation therapy (SBRT) can be shown to be superior to hypofractionated intensity-modulated radiation therapy (IMRT) in terms of genitourinary (GU) and gastrointestinal (GI) toxicity by having fewer patients that experience a minimal important decline (MID) in urinary irritation/obstructive and bowel Health Related Quality of Life (HRQOL) as measured by Expanded Prostate Cancer Index Composite (EPIC)-26 at 24 months post completion of therapy.

II. To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28 fractions of 2.5 Gy or 20 fractions of 3 Gy) as measured by disease free survival (DFS).

SECONDARY OBJECTIVES:

I. To determine whether SBRT can be shown to be superior to hypofractionated IMRT at 12 and 24 months post completion of therapy in terms of HRQOL by having fewer patients that experience a minimal important decline (MID) bowel (12 months only) sexual, hormonal, urinary irritation/obstructive (12 months only) and in urinary incontinence HRQOL as measured by EPIC-26.

II. To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28 fractions of 2.5 Gy or 20 fractions of 3 Gy) as measured by biochemical failure, overall survival, local failure, prostate cancer specific survival, and distant metastases.

III. To determine the correspondence between the diagnostic magnetic resonance imaging (MRI) and biopsy.

IV. To determine if prostate imaging-reporting and data system (PIRADS)version (v)2.1 = 4/5 disease is prognostic for biochemical failure.

EXPLORATORY OBJECTIVES:

I. To determine whether a potentially more expensive therapy, SBRT, would be cost-effective than standard hypofractionated IMRT as measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).

II. To determine if disease characteristics captured on baseline and follow-up MRI can be used to predict which patients will respond to SBRT versus hypofractionated IMRT.

III. To validate autosegmentation tools for the prostate and tumors. IV. Collect specimens for future translational research analyses.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients undergo IMRT once daily for 5 fractions per week for 20 or 28 fractions over less than 32 business days.

ARM II: Patients undergo SBRT at least every other day for 2-3 fractions per week over less than 17 business days.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
692

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital and Cancer Center-General Campus
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Centre De Sante Et De Services Sociaux De Chicoutimi
      • Montreal, Quebec, Canada, H3H 2R9
        • The Research Institute of the McGill University Health Centre (MUHC)
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM - Centre hospitalier de l'Université de Montréal
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSSEMTL-Hopital Maisonneuve-Rosemont
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • Hong Kong
      • Chai Wan, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital
  • India
      • Mumbai, India, 400 012
        • Tata Memorial Hospital
  • Ireland
    • Co Dublin
      • Dublin, Co Dublin, Ireland, 18
        • Beacon Hospital
      • Dublin, Co Dublin, Ireland, 6
        • Saint Lukes Hospital
  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonsspital Aarau
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
        • Mobile Infirmary Medical Center
      • Tuscaloosa, Alabama, United States, 35401
        • Lewis and Faye Manderson Cancer Center
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Arizona Center for Cancer Care - Gilbert
      • Peoria, Arizona, United States, 85381
        • Arizona Center for Cancer Care-Peoria
      • Scottsdale, Arizona, United States, 85258
        • Arizona Center for Cancer Care - Scottsdale
      • Surprise, Arizona, United States, 85374
        • Arizona Center for Cancer Care-Surprise
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology Associates-West Orange Grove
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Anaheim, California, United States, 92806
        • Kaiser Permanente-Anaheim
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Carmichael, California, United States, 95608
        • Mercy San Juan Medical Center
      • Carmichael, California, United States, 95608
        • Mercy Cancer Center - Carmichael
      • Dublin, California, United States, 94568
        • Kaiser Permanente Dublin
      • Elk Grove, California, United States, 95758
        • Mercy Cancer Center - Elk Grove
      • Fresno, California, United States, 93720
        • Fresno Cancer Center
      • Greenbrae, California, United States, 94904
        • Marin General Hospital
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, United States, 90033
        • Los Angeles General Medical Center
      • Modesto, California, United States, 95355
        • Memorial Medical Center
      • Oakland, California, United States, 94611
        • Kaiser Permanente Oakland-Broadway
      • Orange, California, United States, 92868
        • Saint Joseph Hospital - Orange
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Institute Palo Alto
      • Rancho Cordova, California, United States, 95670
        • Kaiser Permanente-Rancho Cordova Cancer Center
      • Rocklin, California, United States, 95765
        • Mercy Cancer Center - Rocklin
      • Rohnert Park, California, United States, 94928
        • Rohnert Park Cancer Center
      • Roseville, California, United States, 95678
        • The Permanente Medical Group-Roseville Radiation Oncology
      • Sacramento, California, United States, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center
      • Sacramento, California, United States, 95816
        • Mercy Cancer Center - Sacramento
      • Salinas, California, United States, 93901
        • Salinas Valley Memorial
      • San Jose, California, United States, 95124
        • Stanford Cancer Center South Bay
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente Cancer Treatment Center
      • Truckee, California, United States, 96161
        • Gene Upshaw Memorial Tahoe Forest Cancer Center
      • Woodland, California, United States, 95695
        • Woodland Memorial Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • UCHealth University of Colorado Hospital
      • Colorado Springs, Colorado, United States, 80909
        • UCHealth Memorial Hospital Central
      • Colorado Springs, Colorado, United States, 80920
        • Memorial Hospital North
      • Denver, Colorado, United States, 80210
        • AdventHealth Porter
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Glenwood Springs, Colorado, United States, 81601
        • Valley View Hospital Cancer Center
      • Littleton, Colorado, United States, 80122
        • AdventHealth Littleton
      • Parker, Colorado, United States, 80138
        • AdventHealth Parker
    • Connecticut
      • Guilford, Connecticut, United States, 06437
        • Smilow Cancer Hospital Care Center - Guilford
      • New Haven, Connecticut, United States, 06520
        • Yale University
      • Trumbull, Connecticut, United States, 06611
        • Smilow Cancer Hospital Care Center-Trumbull
      • Waterford, Connecticut, United States, 06385
        • Smilow Cancer Hospital Care Center - Waterford
    • Delaware
      • Millville, Delaware, United States, 19967
        • Beebe South Coastal Health Campus
      • Newark, Delaware, United States, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System-Christiana Hospital
      • Rehoboth Beach, Delaware, United States, 19971
        • Beebe Health Campus
    • Florida
      • Atlantis, Florida, United States, 33462
        • John Fitzgerald Kennedy Medical Center
      • Aventura, Florida, United States, 33180
        • Mount Sinai Comprehensive Cancer Center at Aventura
      • Deerfield Beach, Florida, United States, 33064
        • Broward Health North
      • Fort Lauderdale, Florida, United States, 33316
        • Broward Health Medical Center
      • Key West, Florida, United States, 33040
        • GenesisCare USA - Key West
      • Lakewood Rch, Florida, United States, 34202
        • GenesisCare USA - Lakewood Ranch
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Plantation, Florida, United States, 33324
        • GenesisCare USA - Plantation
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, United States, 30342
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, United States, 30303
        • Grady Health System
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Fayetteville, Georgia, United States, 30214
        • Piedmont Fayette Hospital
      • Savannah, Georgia, United States, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Nampa, Idaho, United States, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Rush-Copley Medical Center
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Hines, Illinois, United States, 60141
        • Edward Hines Jr VA Hospital
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
      • Springfield, Illinois, United States, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Zion, Illinois, United States, 60099
        • Midwestern Regional Medical Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Parkview Hospital Randallia
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Regional Medical Center
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Health Indianapolis
      • Mooresville, Indiana, United States, 46158
        • Franciscan Health Mooresville
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
      • Overland Park, Kansas, United States, 66210
        • University of Kansas Cancer Center-Overland Park
      • Wichita, Kansas, United States, 67214
        • Ascension Via Christi Hospitals Wichita
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, United States, 40202
        • The James Graham Brown Cancer Center at University of Louisville
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • East Jefferson General Hospital
      • Metairie, Louisiana, United States, 70006
        • LSU Healthcare Network / Metairie Multi-Specialty Clinic
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
    • Maine
      • Bath, Maine, United States, 04530
        • MaineHealth Coastal Cancer Treatment Center
      • Portland, Maine, United States, 04102
        • MaineHealth Maine Medical Center - Portland
      • Sanford, Maine, United States, 04073
        • MaineHealth Cancer Care Center of York County
      • Scarborough, Maine, United States, 04074
        • MaineHealth Maine Medical Center- Scarborough
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Luminis Health Anne Arundel Medical Center
      • Baltimore, Maryland, United States, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Baltimore, Maryland, United States, 21229
        • Saint Agnes Hospital
      • Bethesda, Maryland, United States, 20889-5600
        • Walter Reed National Military Medical Center
      • Columbia, Maryland, United States, 21044
        • Central Maryland Radiation Oncology in Howard County
      • Easton, Maryland, United States, 21601
        • University of Maryland Shore Medical Center at Easton
      • Glen Burnie, Maryland, United States, 21061
        • UM Baltimore Washington Medical Center/Tate Cancer Center
      • Ocean Pines, Maryland, United States, 21811
        • TidalHealth Richard A Henson Cancer Institute
      • Salisbury, Maryland, United States, 21801
        • TidalHealth Peninsula Regional
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
      • Danvers, Massachusetts, United States, 01923
        • Mass General/North Shore Cancer Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Rogel Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Bay City, Michigan, United States, 48706
        • McLaren Cancer Institute-Bay City
      • Clarkston, Michigan, United States, 48346
        • McLaren Cancer Institute-Clarkston
      • Clarkston, Michigan, United States, 48346
        • Michigan Healthcare Professionals Clarkston
      • Dearborn, Michigan, United States, 48124
        • Corewell Health Dearborn Hospital
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Farmington Hills, Michigan, United States, 48334
        • Weisberg Cancer Treatment Center
      • Farmington Hills, Michigan, United States, 48334
        • Michigan Healthcare Professionals Farmington
      • Farmington Hills, Michigan, United States, 48336
        • Corewell Health Farmington Hills Hospital
      • Flint, Michigan, United States, 48532
        • McLaren Cancer Institute-Flint
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Lansing, Michigan, United States, 48910
        • Karmanos Cancer Institute at McLaren Greater Lansing
      • Lansing, Michigan, United States, 48912
        • University of Michigan Health - Sparrow Lansing
      • Macomb, Michigan, United States, 48044
        • Michigan Healthcare Professionals Macomb
      • Madison Heights, Michigan, United States, 48071
        • Michigan Healthcare Professionals Madison Heights
      • Mount Clemens, Michigan, United States, 48043
        • McLaren Cancer Institute-Macomb
      • Petoskey, Michigan, United States, 49770
        • McLaren Cancer Institute-Northern Michigan
      • Port Huron, Michigan, United States, 48060
        • McLaren-Port Huron
      • Royal Oak, Michigan, United States, 48073
        • Corewell Health William Beaumont University Hospital
      • Troy, Michigan, United States, 48098
        • Michigan Healthcare Professionals Troy
      • Troy, Michigan, United States, 48085
        • Corewell Health Beaumont Troy Hospital
      • Wyoming, Michigan, United States, 49519
        • University of Michigan Health - West
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Sanford Joe Lueken Cancer Center
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, United States, 63703
        • Mercy Cancer Center - Cape Girardeau
      • City of Saint Peters, Missouri, United States, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Creve Coeur, Missouri, United States, 63141
        • Siteman Cancer Center at West County Hospital
      • Rolla, Missouri, United States, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63129
        • Siteman Cancer Center-South County
      • St Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, United States, 63104
        • SSM Health Saint Louis University Hospital
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Health Deaconess Hospital
      • Butte, Montana, United States, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, United States, 59405
        • Benefis Sletten Cancer Institute
      • Kalispell, Montana, United States, 59901
        • Logan Health Medical Center
      • Missoula, Montana, United States, 59804
        • Community Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Hampshire
      • Exeter, New Hampshire, United States, 03833
        • Exeter Hospital
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital - Luckow Pavilion
      • Pennington, New Jersey, United States, 08534
        • Capital Health Medical Center-Hopewell
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Lovelace Radiation Oncology
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Oncology Hematology Consultants
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center
    • New York
      • Albany, New York, United States, 12208
        • Saint Peter's Health Partners
      • Brooklyn, New York, United States, 11215
        • New York-Presbyterian/Brooklyn Methodist Hospital
      • Canandaigua, New York, United States, 14424
        • Sands Cancer Center
      • Cooperstown, New York, United States, 13326
        • Mary Imogene Bassett Hospital
      • Middletown, New York, United States, 10940
        • Garnet Health Medical Center
      • New York, New York, United States, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Rochester, New York, United States, 14620
        • Highland Hospital
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center
      • Laurinburg, North Carolina, United States, 28352
        • Scotland Memorial Hospital-Laurinburg Cancer Center
      • Raleigh, North Carolina, United States, 27609
        • Duke Cancer Center Raleigh
      • Supply, North Carolina, United States, 28462
        • Novant Cancer Institute Radiation Oncology - Supply
      • Wilmington, North Carolina, United States, 28401
        • Novant Health Cancer Institute Radiation Oncology - Wilmington
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Roger Maris Cancer Center
    • Ohio
      • Akron, Ohio, United States, 44307
        • Cleveland Clinic Akron General
      • Beachwood, Ohio, United States, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Chardon, Ohio, United States, 44024
        • Geauga Hospital
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Elyria, Ohio, United States, 44035
        • Mercy Cancer Center-Elyria
      • Independence, Ohio, United States, 44131
        • Cleveland Clinic Cancer Center Independence
      • Mansfield, Ohio, United States, 44906
        • Cleveland Clinic Cancer Center Mansfield
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, United States, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
      • Ravenna, Ohio, United States, 44266
        • University Hospitals Portage Medical Center
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care
      • Sylvania, Ohio, United States, 43560
        • ProMedica Flower Hospital
      • Westlake, Ohio, United States, 44145
        • UHHS-Westlake Medical Center
      • Wooster, Ohio, United States, 44691
        • Cleveland Clinic Wooster Family Health and Surgery Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Legacy Mount Hood Medical Center
      • Portland, Oregon, United States, 97210
        • Legacy Good Samaritan Hospital and Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Chadds Ford, Pennsylvania, United States, 19317
        • Christiana Care Health System-Concord Health Center
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Drexel Hill, Pennsylvania, United States, 19026
        • Delaware County Memorial Hospital
      • East Norriton, Pennsylvania, United States, 19401
        • Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
      • Furlong, Pennsylvania, United States, 18925
        • Fox Chase Cancer Center Buckingham
      • Gettysburg, Pennsylvania, United States, 17325
        • Adams Cancer Center
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Lewisburg, Pennsylvania, United States, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Lewistown, Pennsylvania, United States, 17044
        • Lewistown Hospital
      • Paoli, Pennsylvania, United States, 19301
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19114
        • Jefferson Torresdale Hospital
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Pottsville, Pennsylvania, United States, 17901
        • Geisinger Cancer Services-Pottsville
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
      • Willow Grove, Pennsylvania, United States, 19090
        • Asplundh Cancer Pavilion
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
      • York, Pennsylvania, United States, 17403
        • WellSpan Health-York Cancer Center
    • South Carolina
      • Boiling Springs, South Carolina, United States, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, United States, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, United States, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenwood, South Carolina, United States, 29646
        • Self Regional Healthcare
      • Greer, South Carolina, United States, 29650
        • Prisma Health Cancer Institute - Greer
      • Hilton Head Island, South Carolina, United States, 29926
        • The Radiation Oncology Center-Hilton Head/Bluffton
      • Myrtle Beach, South Carolina, United States, 29577
        • Carolina Regional Cancer Center
      • Seneca, South Carolina, United States, 29672
        • Prisma Health Cancer Institute - Seneca
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Center
    • Texas
      • Abilene, Texas, United States, 79606
        • Texas Cancer Center
      • McKinney, Texas, United States, 75071
        • Texas Oncology-McKinney
      • Plano, Texas, United States, 75093
        • Texas Oncology-Plano West
      • Sugar Land, Texas, United States, 77479
        • Texas Oncology Cancer Center Sugar Land
      • Webster, Texas, United States, 77598
        • Deke Slayton Cancer Center
    • Utah
      • Logan, Utah, United States, 84321
        • Logan Regional Hospital
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center
      • St. George, Utah, United States, 84770
        • Saint George Regional Medical Center
    • Vermont
      • Berlin Corners, Vermont, United States, 05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
      • Saint Johnsbury, Vermont, United States, 05819
        • Dartmouth Cancer Center - North
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Sentara Cancer Institute at Sentara CarePlex Hospital
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
      • Norfolk, Virginia, United States, 23505
        • Bon Secours DePaul Medical Center
      • Richmond, Virginia, United States, 23230
        • Bon Secours Cancer Institute at Reynolds Crossing
      • Roanoke, Virginia, United States, 24014
        • Oncology and Hematology Associates of Southwest Virginia
      • Suffolk, Virginia, United States, 23434
        • Sentara Obici Hospital
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Vancouver, Washington, United States, 98686
        • Legacy Salmon Creek Hospital
      • Walla Walla, Washington, United States, 99362
        • Providence Saint Mary Regional Cancer Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • West Virginia University Charleston Division
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Healthcare
    • Wisconsin
      • Appleton, Wisconsin, United States, 54915
        • Ascension Saint Elizabeth Hospital
      • Brookfield, Wisconsin, United States, 53045
        • Ascension Southeast Wisconsin Hospital - Elmbrook Campus
      • Franklin, Wisconsin, United States, 53132
        • Ascension Saint Francis - Reiman Cancer Center
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Menomonee Falls, Wisconsin, United States, 53051
        • Froedtert Menomonee Falls Hospital
      • Mequon, Wisconsin, United States, 53097
        • Ascension Columbia Saint Mary's Hospital Ozaukee
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee, Wisconsin, United States, 53211
        • Ascension Columbia Saint Mary's Hospital - Milwaukee
      • Milwaukee, Wisconsin, United States, 53295
        • Zablocki Veterans Administration Medical Center
      • Oak Creek, Wisconsin, United States, 53154
        • Drexel Town Square Health Center
      • Oshkosh, Wisconsin, United States, 54904
        • Ascension Mercy Hospital
      • Oshkosh, Wisconsin, United States, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Racine, Wisconsin, United States, 53405
        • Ascension All Saints Hospital
      • Summit, Wisconsin, United States, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, United States, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • West Bend, Wisconsin, United States, 53095
        • Froedtert West Bend Hospital/Kraemer Cancer Center

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • International prostate symptom score (IPSS) of < 15 21 days prior to registration
  • The patient must provide study-specific informed consent prior to study entry
  • Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire
  • Completion of all items of the EPIC-26 which will be data entered at registration 60 days prior to registration
  • Only English, Spanish, and French-speaking patients are eligible to participate as these are the only languages EPIC-26 has been validated in

Exclusion Criteria:

  • 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:

    • Human immunodeficiency virus (HIV) positive with CD4 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; this exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive
    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm I (IMRT)
Patients undergo IMRT once daily for 5 fractions per week for 20 or 28 fractions over less than 32 business days.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy
  • Intensity modulated radiation therapy (procedure)
Experimental: Arm II (SBRT)
Patients undergo SBRT at least every other day for 2-3 fractions per week over less than 17 business days.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SBRT
  • SABR
  • Stereotactic Ablative Body Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of patients-reported gastrointestinal and genitourinary toxicity
Time Frame: Up to 2 years
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
Time Frame: Time to biochemical failure (Phoenix definition), local failure, regional failure, distant metastasis, or death from any cause, assessed up to 2 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Presence of Prostate Imaging-Reporting and Data System version (PIRADSv) 2 = 4/5 disease
Time Frame: Baseline
Will be assessed by magnetic resonance imaging (MRI).
Baseline
Health related quality of life
Time Frame: Up to 2 years
Will be measured by EPIC-26 urinary incontinence, sexual, and hormonal domains.
Up to 2 years
Biochemical failure
Time Frame: Up to 2 years
Will be assessed by Phoenix definition.
Up to 2 years
Local failure
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Prostate cancer specific survival
Time Frame: Up to 2 years
Up to 2 years
Overall survival
Time Frame: From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 5 years
Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test.
From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 5 years
Incidence of adverse events (AEs)
Time Frame: Up to 2 years
Will be assessed by Common Terminology Criteria for Adverse Events version 5.0. Counts of all AEs by grade will be provided by treatment arm. Counts and frequencies will be provided for the worst grade AE experienced by the patient by treatment arm. The number of patients with at least 1 grade 3 or higher AE will be compared between the treatment arms. A comparison between treatment arms of grade 3 and higher genitourinary (GU) and gastrointestinal (GI) events related to treatment (separately) will also be tested. There are 5 pre-specified AEs, dysuria, hematuria, incontinence, rectal bleeding, and fatigue. A comparison of any event and grade and higher events will be compared between treatment arms. All comparisons will be tested using a Chi-Square test with a significance level of 0.05.
Up to 2 years
Predictive value of PIRADSv2 = 4/5 disease for biochemical failure
Time Frame: Up to 2 years
Predictive value of PIRADSv2 = 4/5 disease for biochemical failure
Up to 2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Central manual user segmentation of tumors
Time Frame: Up to 2 years
Central manual user segmentation of tumors
Up to 2 years
Performance of supervised automated tumor detection toolset
Time Frame: Up to 2 years
Performance of supervised automated tumor detection toolset
Up to 2 years
Performance of supervised automated tumor segmentation toolset
Time Frame: Up to 5 years
Performance of supervised automated tumor segmentation toolset
Up to 5 years
Image registration performance
Time Frame: Up to 2 years
Image registration performance
Up to 2 years
Predictive utility of radiomic analysis
Time Frame: Up to 2 years
Predictive utility of radiomic analysis
Up to 2 years
Predictive value for local control and biochemical failure
Time Frame: At 2 years
Will be assessed by MRI.
At 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NRG Oncology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rodney J Ellis, NRG Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NRG-GU005 (Other Identifier: CTEP)
  • U10CA180868 (U.S. NIH Grant/Contract)
  • NCI-2017-01398 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Dietary Supplements

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