AzTrials
AzTrials

Stage II Prostate Adenocarcinoma AJCC v7Phase 3NCT03367702

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

A Phase 3 study testing Intensity-Modulated Radiation Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Stage II Prostate Adenocarcinoma AJCC v7, run by NRG Oncology at 293 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Stage II Prostate Adenocarcinoma AJCC v7
What is being tested?
Intensity-Modulated Radiation Therapy, Quality-of-Life Assessment and Questionnaire Administration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
698 participants
Where
293 sitesin 6 countries
Study dates
1 Feb 2018to 1 Dec 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • > 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

293 sites in 6 countries.

293 sites in 6 countries

United States276 sites

  • Texas Cancer Center

    Abilene, Texas, 79606

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • Saint Peter's Health Partners

    Albany, New York, 12208

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Lovelace Radiation Oncology

    Albuquerque, New Mexico, 87109

  • New Mexico Oncology Hematology Consultants

    Albuquerque, New Mexico, 87109

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • Luminis Health Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Ascension Saint Elizabeth Hospital

    Appleton, Wisconsin, 54915

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • John Fitzgerald Kennedy Medical Center

    Atlantis, Florida, 33462

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • MaineHealth Coastal Cancer Treatment Center

    Bath, Maine, 04530

  • McLaren Cancer Institute-Bay City

    Bay City, Michigan, 48706

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Ascension Southeast Wisconsin Hospital - Elmbrook Campus

    Brookfield, Wisconsin, 53045

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Sands Cancer Center

    Canandiaqua, New York, 14424

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Mercy Cancer Center - Carmichael

    Carmichael, California, 95608

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Geauga Hospital

    Chardon, Ohio, 44024

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University Charleston Division

    Charleston, West Virginia, 25304

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • McLaren Cancer Institute-Clarkston

    Clarkston, Michigan, 48346

  • Michigan Healthcare Professionals Clarkston

    Clarkston, Michigan, 48346

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Mass General/North Shore Cancer Center

    Danvers, Massachusetts, 01923

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Broward Health North

    Deerfield Beach, Florida, 33064

  • AdventHealth Porter

    Denver, Colorado, 80210

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Kaiser Permanente Dublin

    Dublin, California, 94568

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Fox Chase Cancer Center - East Norriton Hospital Outpatient Center

    East Norriton, Pennsylvania, 19401

  • University of Maryland Shore Medical Center at Easton

    Easton, Maryland, 21601

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Mercy Cancer Center - Elk Grove

    Elk Grove, California, 95758

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • Exeter Hospital

    Exeter, New Hampshire, 03833

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Michigan Healthcare Professionals Farmington

    Farmington Hills, Michigan, 48334

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Corewell Health Farmington Hills Hospital

    Farmington Hills, Michigan, 48336

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • McLaren Cancer Institute-Flint

    Flint, Michigan, 48532

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805

  • Parkview Regional Medical Center

    Fort Wayne, Indiana, 46845

  • Ascension Saint Francis - Reiman Cancer Center

    Franklin, Wisconsin, 53132

  • Fresno Cancer Center

    Fresno, California, 93720

  • Fox Chase Cancer Center Buckingham

    Furlong, Pennsylvania, 18925

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Arizona Center for Cancer Care - Gilbert

    Gilbert, Arizona, 85297

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

  • Valley View Hospital Cancer Center

    Glenwood Springs, Colorado, 81601

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Marin General Hospital

    Greenbrae, California, 94904

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437

  • Sentara Cancer Institute at Sentara CarePlex Hospital

    Hampton, Virginia, 23666

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • The Radiation Oncology Center-Hilton Head/Bluffton

    Hilton Head Island, South Carolina, 29926

  • Edward Hines Jr VA Hospital

    Hines, Illinois, 60141

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • GenesisCare USA - Key West

    Key West, Florida, 33040

  • Covenant Health Cancer Centers

    Knoxville, Tennessee, 37916

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • GenesisCare USA - Lakewood Ranch

    Lakewood Rch, Florida, 34202

  • Karmanos Cancer Institute at McLaren Greater Lansing

    Lansing, Michigan, 48910

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • Scotland Memorial Hospital-Laurinburg Cancer Center

    Laurinburg, North Carolina, 28352

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • AdventHealth Littleton

    Littleton, Colorado, 80122

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Michigan Healthcare Professionals Macomb

    Macomb, Michigan, 48044

  • Michigan Healthcare Professionals Madison Heights

    Madison Heights, Michigan, 48071

  • Cleveland Clinic Cancer Center Mansfield

    Mansfield, Ohio, 44906

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Texas Oncology-McKinney

    McKinney, Texas, 75071

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • Ascension Columbia Saint Mary's Hospital Ozaukee

    Mequon, Wisconsin, 53097

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

  • LSU Healthcare Network / Metairie Multi-Specialty Clinic

    Metairie, Louisiana, 70006

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Garnet Health Medical Center

    Middletown, New York, 10940

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

  • Ascension Columbia Saint Mary's Hospital - Milwaukee

    Milwaukee, Wisconsin, 53211

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Zablocki Veterans Administration Medical Center

    Milwaukee, Wisconsin, 53295

  • Community Medical Center

    Missoula, Montana, 59804

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36607

  • Memorial Medical Center

    Modesto, California, 95355

  • Franciscan Health Mooresville

    Mooresville, Indiana, 46158

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • McLaren Cancer Institute-Macomb

    Mount Clemens, Michigan, 48043

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Carolina Regional Cancer Center

    Myrtle Beach, South Carolina, 29577

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

  • Yale University

    New Haven, Connecticut, 06520

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Bon Secours DePaul Medical Center

    Norfolk, Virginia, 23505

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

  • Kaiser Permanente Oakland-Broadway

    Oakland, California, 94611

  • TidalHealth Richard A Henson Cancer Institute

    Ocean Pines, Maryland, 21811

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Saint Joseph Hospital - Orange

    Orange, California, 92868

  • Ascension Mercy Hospital

    Oshkosh, Wisconsin, 54904

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • The Valley Hospital - Luckow Pavilion

    Paramus, New Jersey, 07652

  • AdventHealth Parker

    Parker, Colorado, 80138

  • Capital Health Medical Center-Hopewell

    Pennington, New Jersey, 08534

  • Arizona Center for Cancer Care-Peoria

    Peoria, Arizona, 85381

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • McLaren Cancer Institute-Northern Michigan

    Petoskey, Michigan, 49770

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Jefferson Torresdale Hospital

    Philadelphia, Pennsylvania, 19114

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Texas Oncology-Plano West

    Plano, Texas, 75093

  • GenesisCare USA - Plantation

    Plantation, Florida, 33324

  • McLaren-Port Huron

    Port Huron, Michigan, 48060

  • MaineHealth Maine Medical Center - Portland

    Portland, Maine, 04102

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania, 17901

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • Ascension All Saints Hospital

    Racine, Wisconsin, 53405

  • Duke Cancer Center Raleigh

    Raleigh, North Carolina, 27609

  • Kaiser Permanente-Rancho Cordova Cancer Center

    Rancho Cordova, California, 95670

  • University Hospitals Portage Medical Center

    Ravenna, Ohio, 44266

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Bon Secours Cancer Institute at Reynolds Crossing

    Richmond, Virginia, 23230

  • Oncology and Hematology Associates of Southwest Virginia

    Roanoke, Virginia, 24014

  • Highland Hospital

    Rochester, New York, 14620

  • University of Rochester

    Rochester, New York, 14642

  • Mercy Cancer Center - Rocklin

    Rocklin, California, 95765

  • Rohnert Park Cancer Center

    Rohnert Park, California, 94928

  • Phelps Health Delbert Day Cancer Institute

    Rolla, Missouri, 65401

  • The Permanente Medical Group-Roseville Radiation Oncology

    Roseville, California, 95678

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073

  • Mercy Cancer Center - Sacramento

    Sacramento, California, 95816

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Dartmouth Cancer Center - North

    Saint Johnsbury, Vermont, 05819

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Salinas Valley Memorial

    Salinas, California, 93901

  • TidalHealth Peninsula Regional

    Salisbury, Maryland, 21801

  • Stanford Cancer Center South Bay

    San Jose, California, 95124

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • MaineHealth Cancer Care Center of York County

    Sanford, Maine, 04073

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

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

    Savannah, Georgia, 31405

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074

  • Arizona Center for Cancer Care - Scottsdale

    Scottsdale, Arizona, 85258

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Kaiser Permanente Cancer Treatment Center

    South San Francisco, California, 94080

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • SSM Health Saint Louis University Hospital

    St Louis, Missouri, 63104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Saint George Regional Medical Center

    St. George, Utah, 84770

  • Sentara Obici Hospital

    Suffolk, Virginia, 23434

  • Texas Oncology Cancer Center Sugar Land

    Sugar Land, Texas, 77479

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • Novant Cancer Institute Radiation Oncology - Supply

    Supply, North Carolina, 28462

  • Arizona Center for Cancer Care-Surprise

    Surprise, Arizona, 85374

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Corewell Health Beaumont Troy Hospital

    Troy, Michigan, 48085

  • Michigan Healthcare Professionals Troy

    Troy, Michigan, 48098

  • Gene Upshaw Memorial Tahoe Forest Cancer Center

    Truckee, California, 96161

  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, 06611

  • Arizona Oncology Associates-West Orange Grove

    Tucson, Arizona, 85704

  • Lewis and Faye Manderson Cancer Center

    Tuscaloosa, Alabama, 35401

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Legacy Salmon Creek Hospital

    Vancouver, Washington, 98686

  • Providence Saint Mary Regional Cancer Center

    Walla Walla, Washington, 99362

  • Smilow Cancer Hospital Care Center - Waterford

    Waterford, Connecticut, 06385

  • Deke Slayton Cancer Center

    Webster, Texas, 77598

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    West Bend, Wisconsin, 53095

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • UHHS-Westlake Medical Center

    Westlake, Ohio, 44145

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67214

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090

  • Novant Health Cancer Institute Radiation Oncology - Wilmington

    Wilmington, North Carolina, 28401

  • Woodland Memorial Hospital

    Woodland, California, 95695

  • Cleveland Clinic Wooster Family Health and Surgery Center

    Wooster, Ohio, 44691

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • University of Michigan Health - West

    Wyoming, Michigan, 49519

  • WellSpan Health-York Cancer Center

    York, Pennsylvania, 17403

  • Midwestern Regional Medical Center

    Zion, Illinois, 60099

Other trials in United States

Canada12 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Centre De Sante Et De Services Sociaux De Chicoutimi

    Chicoutimi, Quebec, G7H 5H6

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • CIUSSSEMTL-Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

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

    Montreal, Quebec, H3H 2R9

  • Ottawa Hospital and Cancer Center-General Campus

    Ottawa, Ontario, K1H 8L6

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

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Ireland2 sites

  • Beacon Hospital

    Dublin, Co Dublin, 18

  • Saint Lukes Hospital

    Dublin, Co Dublin, 6

Other trials in Ireland

Hong Kong1 site

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan

Other trials in Hong Kong

India1 site

  • Tata Memorial Hospital

    Mumbai, 400 012

Other trials in India

Switzerland1 site

  • Kantonsspital Aarau

    Aarau, 5001

Other trials in Switzerland

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Being tested
Intensity-Modulated Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration, Stereotactic Body Radiation Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo IMRT

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Stereotactic Body Radiation TherapyRadiation

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo SBRT

Study groups in NCT03367702
Study groupRoleWhat they receive
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.
Receives: Radiation: Intensity-Modulated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (SBRT)ExperimentalPatients undergo SBRT at least every other day for 2-3 fractions per week over less than 17 business days.
Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Measured: Baseline and two years

  2. Number of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two Years

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Measured: Baseline and two years

  3. Percentage of Participants Alive Without Disease (Disease-free Survival [DSF])

    Disease is defined as biochemical failure (Phoenix definition), local failure, regional failure, distant metastasis, or death from any cause. Disease-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.

    Measured: Randomization to biochemical failure, local failure, regional failure, distant metastasis, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.

Secondary outcomes (17)

  1. Percentage of Participants With Biochemical Failure

    Biochemical failure is defined as a rise in prostate-specific antigen (PSA) of ≥2.0 ng/mL above the post-treatment PSA nadir following radiation therapy for prostate cancer (Phoenix definition). Biochemical failure rates were estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis,

    Measured: Randomization to biochemical failure, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.

  2. Percentage of Participants With Local Failure

    Local failure rates were estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis,

    Measured: Randomization to local failure, death, or last known follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.

  3. Percentage of Participants With Regional Failure

    Regional failure rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with ≤ 10 events overall, such as this one, only the count and raw percentage of participants with the event are provided.

    Measured: From randomization to regional failure, death, or last known follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years.

  4. Percentage of Participants With Distant Metastasis

    Distant metastasis rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with ≤ 10 events overall, such as this one, only the count and raw percentage of participants with the event are provided.

    Measured: Randomization to distant metastasis, death, or last known follow-up date, whichever occurs first. Median follow-up time at time of analysis was 3.2 years.

  5. Percentage of Participants Who Died Due to Prostate Cancer

    Prostate cancer death rates were to be estimated using the cumulative incidence method, treating death due to other causes as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with ≤ 10 events overall, such as this one, only the count and raw percentage of participants with the event are provided.

    Measured: Randomization to death or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years.

  6. Percentage of Particpants Alive (Overall Survival)

    Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.

    Measured: Randomization to death or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.

  7. Number of Participants With a Grade 3 or Higher Adverse Event

    Common Terminology Criteria for Adverse Events (version 5.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Adverse events reported as possibly, probably, or definitely related to treatment are considered to be treatment-related adverse events. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

    Measured: Randomization to death or last follow-up. Median follow-up at time of analysis was 3.2 years.

  8. Number of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at One Year

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Measured: Baseline and one year

  9. Number of Participants With a Decline of ≥4 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at One Year

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Measured: Baseline and one year

  10. Number of Participants With a Decline of ≥6 Points in the EPIC-26 Urinary Incontinence Domain (Minimal Clinically Important Difference) at One Year

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Measured: Baseline and one year

  11. Number of Participants With a Decline of ≥6 Points in the EPIC-26 Urinary Incontinence Domain (Minimal Clinically Important Difference) at Two Years

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Measured: Baseline and two years

  12. Number of Participants With a Decline of ≥4 Points in the EPIC-26 Hormonal Domain (Minimal Clinically Important Difference) at One Year

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Measured: Baseline and one year

  13. Number of Participants With a Decline of ≥4 Points in the EPIC-26 Hormonal Domain (Minimal Clinically Important Difference) at Two Years

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Measured: Baseline and two years

  14. Number of Participants With a Decline of ≥10 Points in the EPIC-26 Sexual Domain (Minimal Clinically Important Difference) at One Year

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Measured: Baseline and one year

  15. Number of Participants With a Decline of ≥10 Points in the EPIC-26 Sexual Domain (Minimal Clinically Important Difference) at Two Years

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Measured: Baseline and two years

  16. Presence of Prostate Imaging-Reporting and Data System Version (PIRADSv) 2 = 4/5 Disease

    Will be assessed by magnetic resonance imaging (MRI).

    Measured: Baseline

  17. Predictive Value of PIRADSv2 = 4/5 Disease for Biochemical Failure

    Predictive value of PIRADSv2 = 4/5 disease for biochemical failure

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2017
  2. Study start1 Feb 2018
  3. Primary completion15 Jan 2025
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
698 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03367702
Sponsor's protocol ID
NRG-GU005
Other IDs
NCI-2017-01398, NRG-GU005, NRG-GU005, U10CA180868
Status last verified
Oct 2026
First submitted
5 Dec 2017
Last updated
29 Oct 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Publications

  • Ellis RJ, Pugh SL, Yu JB, Feng FY, Konski AA, Grubb RL 3rd, Wallace RE, Gladstone DJ, Menard C, Miccio JA, Frazier AJ, Pennington JD, Michalski JM, Spratt DE, Martinez A, Morgan SC, Mihai A, Solanki AA, Amjad A, Straza MW, Delouya G, Schroeder TM, Marshall DT, Kapadia N, Patel AN, Cescon TP, El-Gayed A, Yoon HA, Paulus R, Sandler HM; NRG-GU005 Collaborative Authors. Stereotactic Body Radiotherapy vs Moderately Hypofractionated IMRT for Localized Intermediate-Risk Prostate Cancer: A Randomized Clinical Trial. JAMA. 2026 Aug 13:e2612627. doi: 10.1001/jama.2026.12627. Online ahead of print.

    PubMed 42593775

  • 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.

    PubMed 41063518

  • Alley 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.

    PubMed 36223780

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intensity-Modulated Radiation Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Stage II Prostate Adenocarcinoma AJCC v7, run by NRG Oncology at 293 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 293 sites in United States, Canada, Ireland, Hong Kong, India and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years (time frame: Baseline and two years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03367702, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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