AzTrials
AzTrials

Prostate CancerPhase 3NCT00936390

Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer

A Phase 3 study testing bicalutamide, flutamide and LHRH agonist (antagonist) therapy in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 518 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
bicalutamide, flutamide and LHRH agonist (antagonist) therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,538 participants
Where
518 sitesin 2 countries
Study dates
Sep 2009to 4 Sep 2025
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

  • Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma, at intermediate risk for recurrence, within 180 days prior to registration as determined by having one or more of the following intermediate-risk features: Gleason score 7; prostate-specific antigen (PSA) >10 but ≤20; clinical stage T2b-T2c.
  • Patients previously diagnosed with low risk (Gleason score ≤ 6, clinical stage < T2a, and PSA < 10) prostate cancer undergoing active surveillance who are re-biopsied and found to have intermediate risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure.
  • Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal CT or MRI), nodal sampling, or dissection within 60 days prior to registration, except as noted immediately below:
  • Patients with a single intermediate risk factor only do not require abdominopelvic imaging, but these studies may be obtained at the discretion of the treating physician. Patients with 2 or 3 risk factors are required to undergo pelvic +/- abdominal CT or MRI.
  • Patients with lymph nodes equivocal or questionable by imaging are eligible without biopsy if the nodes are ≤1.5 cm; any node larger than this on imaging will require negative biopsy for eligibility.
  • No evidence of bone metastases (M0) on bone scan within 60 days prior to registration.
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  • Bone scan is not required for patients enrolled with a single intermediate risk factor only, but this scan may be obtained at the discretion of the treating physician. Patients with 2 or 3 risk factors will require a negative bone scan for eligibility.
  • Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis.
  • History/physical examination (to include, at a minimum, digital rectal examination of the prostate and examination of the skeletal system and abdomen, and formal comorbidity assessment via the ACE-27 instrument) within 60 days prior to registration.
  • Zubrod Performance Status 0-1
  • Age ≥ 18
  • Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 60 days prior to registration
  • Study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of ADT; (3) within 30 days after discontinuation of finasteride; or (4) within 90 days after discontinuation of dutasteride.
  • For patients undergoing brachytherapy only: complete blood count (CBC)/differential obtained within 60 days prior to registration, with adequate bone marrow function defined as follows:
  • Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
  • Platelets ≥ 100,000 cells/mm3
  • Hemoglobin (Hgb) ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
  • Patient must be able to provide study-specific informed consent prior to study entry.

Who cannot join

  • Patients with Gleason Score ≥ 8; PSA > 20; OR Clinical Stage ≥ T3 are ineligible for this trial.
  • Should findings of extracapsular extension or seminal vesicle invasion be noted on prostate MRI, this study, if used, will not render patients ineligible for accrual to this protocol. Primary tumor staging for eligibility purposes is to be based on palpable or core biopsy evidence only with respect to extracapsular extension or seminal vesicle involvement.
  • Patients with all three intermediate risk factors who also have ≥ 50% of the number of their biopsy cores positive for cancer are ineligible for this trial.
  • Prior invasive malignancy (except non-melanomatous skin cancer) or hematological (e.g., leukemia, lymphoma, myeloma) malignancy unless disease free for a minimum of 5 years (prior diagnoses of carcinoma in situ are permitted)
  • Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer
  • Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy
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  • Use of finasteride within 30 days prior to registration
  • Use of dutasteride within 90 days prior to registration
  • Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted.
  • Prior RT, including brachytherapy, to the region of the study cancer that would result in overlap of RT fields
  • Any patient undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume <60 cc, American Urological Association Symptom Index (AUA-SI) score ≤15 within 60 days of registration, and no history of prior transurethral resection of the prostate (TURP); prior TURP is permitted for patients who receive EBRT only)
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
  • 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.
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. While the treatment employed in this study is not significantly immunosuppressive, it is felt that a diagnosis of AIDS associated with prostate cancer is likely to impact this study's primary endpoint of overall survival. Patients who are HIV seropositive but do not meet criteria for diagnosis of AIDS are eligible for study participation.
  • Men who are sexually active with a woman of child-bearing potential and not willing/able to use medically acceptable forms of contraception (e.g., surgical, barrier, medicinal) during protocol treatment and during the first 3 months after cessation of protocol treatment; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

Trial locations and contacts

518 sites in 2 countries.

319 sites in 2 countries

United States300 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • Akron General Medical Center

    Akron, Ohio, 44307

  • New York Oncology Hematology PC - Albany

    Albany, New York, 12206

  • Saint Peters Hospital-Albany

    Albany, New York, 12208

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota, 56007

  • Lovelace Medical Center-Downtown

    Albuquerque, New Mexico, 87102

  • University of New Mexico

    Albuquerque, New Mexico, 87102

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Radiation Oncology Associates

    Albuquerque, New Mexico, 87109

  • Inova Alexandria Hospital

    Alexandria, Virginia, 22304

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • Saint Vincent Anderson Regional Hospital/Cancer Center

    Anderson, Indiana, 46016

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Veteran's Administration Medical Center - Ann Arbor

    Ann Arbor, Michigan, 48105

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Appleton Medical Center

    Appleton, Wisconsin, 54911

  • Texas Oncology-Arlington South

    Arlington, Texas, 76014

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Grady Health System

    Atlanta, Georgia, 30303

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Texas Oncology-Austin Midtown

    Austin, Texas, 78705

  • Texas Oncology - Central Austin Cancer Center

    Austin, Texas, 78731

  • Texas Oncology - South Austin Cancer Center

    Austin, Texas, 78745

  • IU Health West Hospital

    Avon, Indiana, 46123

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Summa Barberton Hospital

    Barberton, Ohio, 44203

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • McLaren-Bay Region

    Bay City, Michigan, 48708

  • Southside Hospital

    Bay Shore, New York, 11706

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • Texas Oncology Bedford

    Bedford, Texas, 76022

  • Upper Chesapeake Medical Center

    Bel Air, Maryland, 21015

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Sanford Clinic North-Bemidgi

    Bemidji, Minnesota, 56601

  • Southwestern Vermont Medical Center

    Bennington, Vermont, 05201

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Montana Cancer Consortium CCOP

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Billings Clinic Cancer Center

    Billings, Montana, 59107

  • Lourdes Hospital

    Binghamton, New York, 13905

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Saint Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • IU Health Bloomington

    Bloomington, Indiana, 47403

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Ocean Medical Center

    Brick, New Jersey, 08724

  • State University of New York Downstate Medical Center

    Brooklyn, New York, 11203

  • Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus

    Brooklyn, New York, 11209

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Sands Cancer Center

    Canandiaqua, New York, 14424

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Geaugra Hospital

    Chardon, Ohio, 44024

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612-3785

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Enloe Medical Center

    Chico, California, 95926

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Siteman Cancer Center - Saint Peters

    City of Saint Peters, Missouri, 63376

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Henry Ford Macomb Hospital

    Clinton Township, Michigan, 48038

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Columbus CCOP

    Columbus, Ohio, 43215

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Huron Valley-Sinai Hospital

    Commerce, Michigan, 48382

  • Concord Hospital

    Concord, New Hampshire, 03301

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Northside Hospital-Forsyth

    Cumming, Georgia, 30041

  • Texas Cancer Center - Medical City Dallas

    Dallas, Texas, 75230

  • Texas Oncology Methodist Charlton Cancer Center

    Dallas, Texas, 75237

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Mass General/North Shore Cancer Center

    Danvers, Massachusetts, 01923

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023-1291

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Texas Oncology-Denton South

    Denton, Texas, 76210

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa Oncology Research Association CCOP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Finley Hospital

    Dubuque, Iowa, 52001

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Saint Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Veterans Adminstration New Jersey Health Care System

    East Orange, New Jersey, 07018-1095

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • The Shaw Regional Cancer Center

    Edwards, Colorado, 81632

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • 21st Century Oncology - El Segundo

    El Segundo, California, 90245

  • Arnot Ogden Medical Center/Falck Cancer Center

    Elmira, New York, 14905

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • The Regional Cancer Center

    Erie, Pennsylvania, 16505

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49431

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Exeter Hospital

    Exeter, New Hampshire, 03833

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Saint Anne's Hospital

    Fall River, Massachusetts, 02721

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58122

  • Sanford Medical Center-Fargo

    Fargo, North Dakota, 58122

  • Botsford General Hospital

    Farmington, Michigan, 48334

  • 21st Century Oncology-Farmington Hills

    Farmington Hills, Michigan, 48334

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Augusta Health Cancer Center

    Fishersville, Virginia, 22939

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • McLaren-Flint

    Flint, Michigan, 48532

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Radiation Oncology Associates PC

    Fort Wayne, Indiana, 46804

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805

  • The Klabzuba Cancer Center

    Fort Worth, Texas, 76104

  • CentraState Medical Center

    Freehold, New Jersey, 07728

  • Fresno Cancer Center

    Fresno, California, 93720

  • Saint Agnes Medical Center

    Fresno, California, 93720

  • Fox Chase Cancer Center Buckingham

    Furlong, Pennsylvania, 18925

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Tate Cancer Center

    Glen Burnie, Maryland, 21061

  • IU Health Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81502

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Three Rivers Community Hospital

    Grants Pass, Oregon, 97527

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311-6519

  • Marin General Hospital

    Greenbrae, California, 94904

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Greenville Health System Cancer Institute-Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Sentara Cancer Institute at Sentara CarePlex Hospital

    Hampton, Virginia, 23666

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • Sentara Rockingham Memorial Hospital Hahn Cancer Center

    Harrisonburg, Virginia, 22801

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Yale-New Haven Hospital Saint Raphael Campus

    Hew Haven, Connecticut, 06511

  • Hines Veterans Administration Hospital

    Hines, Illinois, 60141

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Mercy Cancer Center-Hot Springs

    Hot Springs, Arkansas, 71913

  • Memorial Hermann Memorial City Medical Center

    Houston, Texas, 77024

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Richard L. Roudebush Veterans Affairs Medical Center

    Indianapolis, Indiana, 46202

  • IU Health Central Indiana Cancer Centers-East

    Indianapolis, Indiana, 46219

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • UW Cancer Center Johnson Creek

    Johnson Creek, Wisconsin, 53038

  • Mercy Hospital-Joplin

    Joplin, Missouri, 64804

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Kansas City Cancer Center - South

    Kansas City, Missouri, 64131

  • Kansas City Cancer Centers - North

    Kansas City, Missouri, 64154

  • Cheshire Medical Center-Dartmouth-Hitchcock Keene

    Keene, New Hampshire, 03431

  • Academic Urology Prostate Center

    King of Prussia, Pennsylvania, 19406

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Florida Hospital Kissimmee

    Kissimmee, Florida, 34744

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • The Watson Clinic

    Lakeland, Florida, 33805

  • Saint Mary Medical and Regional Cancer Center

    Langhorne, Pennsylvania, 19047

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Great Lakes Cancer Institute-Lapeer Campus

    Lapeer, Michigan, 48446

  • Memorial Medical Center - Las Cruces

    Las Cruces, New Mexico, 88011

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • UTMB Cancer Center at Victory Lakes

    League City, Texas, 77573

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Kansas City Cancer Center-Lee's Summit

    Lee's Summit, Missouri, 64064

  • Central Maine Medical Center

    Lewiston, Maine, 04240

  • Texas Oncology - Lewisville

    Lewisville, Texas, 75067

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Veterans Administration Long Beach Medical Center

    Long Beach, California, 90822

  • Texas Oncology-Longview Cancer Center

    Longview, Texas, 75601

  • Los Angeles County-USC 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

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Elliot Hospital

    Manchester, New Hampshire, 03103

  • North Shore University Hospital

    Manhasset, New York, 11030

  • North Shore-LIJ Health System NCORP

    Manhasset, New York, 11030

  • Mayo Clinic Health Systems-Mankato

    Mankato, Minnesota, 56001

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Vince Lombardi Cancer Clinic-Marinette

    Marinette, Wisconsin, 54143

  • Blount Memorial Hospital

    Maryville, Tennessee, 37804

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Asante Health System

    Medford, Oregon, 97504

  • Providence Medford Medical Center

    Medford, Oregon, 97504

  • Rogue Valley Medical Center

    Medford, Oregon, 97504

  • Summa Health Center at Lake Medina

    Medina, Ohio, 44256

  • Community Memorial Hospital

    Menomonee Falls, Wisconsin, 53051

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Columbia Saint Mary's Hospital - Ozaukee

    Mequon, Wisconsin, 53097

  • Midstate Medical Center

    Meriden, Connecticut, 06451

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

  • Jackson Memorial Hospital-Holtz Children's Hospital

    Miami, Florida, 33136

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • South Miami Hospital

    Miami, Florida, 33143

  • Southwest General Health Center Ireland Cancer Center

    Middleburg Heights, Ohio, 44130

  • Upper Delaware Valley Cancer Center

    Milford, Pennsylvania, 18337

  • Columbia Saint Mary's Water Tower Medical Commons

    Milwaukee, Wisconsin, 53211

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Zablocki Veterans Administration Medical Center

    Milwaukee, Wisconsin, 53295

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Trinity Cancer Care Center

    Minot, North Dakota, 58701

  • Memorial Medical Center

    Modesto, California, 95355

  • Princeton Radiation Oncology Center

    Monroe, New Jersey, 08831

  • The Coleman Radiation Center-Carteret General Hospital

    Morehead City, North Carolina, 28557

  • McLaren-Macomb

    Mount Clemens, Michigan, 48043

  • Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

    Mount Holly, New Jersey, 08060

  • McLaren-Central Michigan

    Mount Pleasant, Michigan, 48858

  • Intermountain Medical Center

    Murray, Utah, 84157

  • Mercy Health Mercy Campus

    Muskegon, Michigan, 49444

  • Carolina Regional Cancer Center

    Myrtle Beach, South Carolina, 29577

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07753

  • CarolinaEast Health System-Medical Center

    New Bern, North Carolina, 28560

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • UMDNJ - Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08903

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • North Shore-LIJ Health System/Center for Advanced Medicine

    New Hyde Park, New York, 11040

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

Other trials in United States

Canada19 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • QEII Health Sciences Centre/Capital District Health Authority

    Halifax, Nova Scotia, B3H 1V8

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • BCCA-Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • Ottawa Health Research Institute-General Division

    Ottawa, Ontario, K1H 1C4

  • Irving Greenberg Family Cancer Centre

    Ottawa, Ontario, K2H 8P4

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

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Atlantic Health Sciences Corporation-Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • Thunder Bay Regional Health Science Centre

    Thunder Bay, Ontario, P7B 6V4

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • BCCA-Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

About this study

Official title: A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Demonstrate an overall survival (OS) advantage in patients with intermediate-risk prostate cancer treated with dose-escalated radiotherapy (RT) with versus without short-term androgen-deprivation therapy (ADT).

Secondary

  • Determine whether the addition of ADT to dose-escalated RT versus RT alone improves clinical failures, biochemical failure by the "nadir +2", freedom from failure, rate of salvage ADT, and prostate cancer-specific mortality in these patients.
  • Estimate the magnitude of benefit of ADT with respect to OS in patients treated with different RT modalities (i.e., external-beam radiation therapy alone vs low-dose rate brachytherapy boost vs high-dose rate brachytherapy boost).
  • Compare acute and late treatment adverse events of these regimens and correlate these events with the presence or absence of pre-existing comorbidity as documented by the Adult Comorbidity Evaluation 27 assessment.

OUTLINE: This is a multicenter, dose-escalation study of radiotherapy. Patients are stratified according to number of risk factors (1 vs 2-3), comorbidity (ACE-27 grade ≥ 2 vs < 2), and radiotherapy (RT) modality (dose-escalated external-beam RT [EBRT] vs EBRT and low-dose rate brachytherapy boost vs EBRT and high-dose rate brachytherapy boost). Patients are randomized to 1 of 2 treatment arms. After completion of study therapy, patients are followed up periodically.

Conditions
Prostate Cancer
Being tested
bicalutamide, flutamide, LHRH agonist (antagonist) therapy, Dose-Escalated Radiation Therapy
Keywords
adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • bicalutamideDrug

    Administered orally at a dose of one 50 mg tablet per day, beginning within (before, same day as, or after) 10 days of the date of the first LHRH agonist (antagonist) therapy administration and continuing for a total duration of 6 months.

  • flutamideDrug

    Also called anti-androgen therapy

    Administered orally at a dose of 250 mg (two 125-mg capsules) three times a day for a total daily dose of 750 mg, beginning within (before, same day as, or after) 10 days of with the date of the first LHRH agonist (antagonist) therapy administration and continuing for a total duration of 6 months.

  • LHRH agonist (antagonist) therapyDrug

    Also called leuprolide, goserelin, buserelin, triptorelin

    LHRH agonist (antagonist) therapy consists of leuprolide, goserelin, buserelin, triptorelin, or degarelix. The manufacturer's instructions should be followed. The first administration occurs with the start of anti-androgen treatment 8 weeks prior to the start of RT. The total duration of LHRH agonist (antagonist) therapy is 6 months.

  • Dose-Escalated Radiation TherapyRadiation

    External beam radiotherapy (EBRT) as 3D Conformal Radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT). Brachytherapy is optional, at the discretion of the treating physician. Patients treated entirely via EBRT receive 79.2 Gy delivered in 1.8 Gy fractions. Patients who receive brachytherapy as a component of their RT receive 45 Gy EBRT in 1.8 Gy fractions. Low-dose brachytherapy boost occurs following the EBRT portion of treatment no more than 4 weeks following its completion.High-dose rate brachytherapy boost is delivered in 2 fractions separated by a minimum time span of 6 hours and the implant(s) may be performed during the EBRT portion of the treatment or within 1 week prior to its initiation or following its completion.

Study groups in NCT00936390
Study groupRoleWhat they receive
Dose-Escalated Radiation Therapy AloneActive comparatorRadiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions.
Receives: Radiation: Dose-Escalated Radiation Therapy
Dose-Escalated Radiation Therapy and Short-Term Androgen-DeprivationExperimentalRadiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions. Six months of androgen-deprivation therapy starts 8 weeks prior to start of radiation therapy and consists of luteinizing-hormone releasing-hormone (LHRH) agonist (antagonist) therapy (leuprolide, goserelin, buserelin. triptorelin, or degarelix) and anti-androgen therapy (bicalutamide or flutamide).
Receives: Drug: bicalutamide; Drug: flutamide; Drug: LHRH agonist (antagonist) therapy; Radiation: Dose-Escalated Radiation Therapy

What is being measured

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

  1. Percentage of Participants Alive (Overall Survival)

    Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

    Measured: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.

Secondary outcomes (18)

  1. Percentage of Participants With Biochemical Failure

    Biochemical failure is defined as an increase of at least 2 ng/ml above the nadir PSA. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

    Measured: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.

  2. Percentage of Participants With Local Recurrence

    Local recurrence (failure) is defined as clinical (palpable) suspicion of local recurrence [this date is used] confirmed by biopsy. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

    Measured: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.

  3. Percentage of Participants With Regional Recurrence

    Regional recurrence is defined as the documented progression in pelvic lymph nodes. If discovered on image of the pelvis prompted by a biochemical failure, then the event date would be the date of documented biochemical failure.

    Measured: From randomization to last follow-up. Maximum follow-up at time of analysis was 10.3 years.

  4. Percentage of Participants With Distant Metastasis

    Distant metastasis (failure) is defined as metastatic disease documented by any method. If diagnosed on diagnostic imaging prompted by biochemical failure, then the event date will be the date of biochemical progression.

    Failure time is defined as time from randomization to the date of first failure, last known follow-up (competing risk), or death without failure (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

    Measured: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.

  5. Percentage of Participants Dead Due to Prostate Cancer (Prostate Cancer-specific Mortality)

    Prostate cancer specific mortality (failure) is defined as death due to prostate cancer or a complication from treatment. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

    Measured: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.

  6. Percentage of Participants Dead Due to Cause Other Than Prostate Cancer (Non-Prostate Cancer-specific Mortality)

    Non-prostate cancer specific mortality is defined as a death without evidence of prostate cancer or a complication from treatment. . Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

    Measured: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.

  7. Percentage of Participants Receiving Salvage Androgen Deprivation Therapy (ADT)

    Salvage (non-protocol) ADT administration is defined as the first administration of subsequent ADT (either LHRH agonist or anti-androgen) Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Salvage ADT rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of salvage ADT times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

    Measured: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.

  8. Percentage of Participants Alive (Overall Survival) by Radiation Therapy Modality

    Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

    Measured: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.

  9. Number of Participants With Acute Adverse Events

    Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Acute adverse events are defined as occuring within 30 days of completion of radiation therapy.

    Measured: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years.

  10. Percentage of Participants With Late Grade 3+ Adverse Events

    Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Late adverse events are defined as occurring more than 30 days after the end of radiation therapy. Failure is defined as grade 3 or higher late adverse event. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

    Measured: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates are reported here.

  11. Percentage of Participants Failed (Freedom From Failure)

    Failure is defined as biochemical failure, local failure, or distant metastasis. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

    Measured: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates are reported here.

  12. Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Urinary Domain Score

    The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement.

    Measured: Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT.

  13. Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score

    The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement.

    Measured: Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT.

  14. Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Score

    The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement.

    Measured: Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT.

  15. Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score

    The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement.

    Measured: Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT.

  16. Change From Baseline in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Domain Score

    The PROMIS Fatigue short form 8a contains 8 questions, each with 5 responses ranging from 1 to 5, evaluating self-reported fatigue symptoms over the past 7 days. The total score is the sum of all questions which is then converted into a pro-rated T-score with a mean of 50 and standard deviation of 10, with a possible range of 33.1 to 77.8. Higher scores indicate more fatigue. Change is defined as value at one year - value at baseline. Positive change from baseline indicates increased fatigue at one year.

    Measured: Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT.

  17. Quality Adjusted Life Years (QALYs)

    Measured: Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT.

  18. Correlation Between PROMIS Fatigue Score Change and Plasma Cytokine Change

    Measured: From date of randomization to 3 weeks from start of RT.

Timeline

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

  1. First posted10 Jul 2009 (estimated)
  2. Study startSep 2009
  3. Primary completion3 Oct 2020
  4. Study completion4 Sep 2025

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
1,538 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00936390
Sponsor's protocol ID
RTOG 0815
Other IDs
CDR0000648194, NCI-2011-01948
Status last verified
Sep 2025
First submitted
8 Jul 2009
Last updated
6 Mar 2026
Data monitoring committee
Yes

Publications

  • Krauss DJ, Karrison T, Martinez AA, Morton G, Yan D, Bruner DW, Movsas B, Elshaikh M, Citrin D, Hershatter B, Michalski JM, Efstathiou JA, Currey A, Kavadi VS, Cury FL, Lock M, Raben A, Seaward SA, El-Gayed A, Rodgers JP, Sandler HM. Dose-Escalated Radiotherapy Alone or in Combination With Short-Term Androgen Deprivation for Intermediate-Risk Prostate Cancer: Results of a Phase III Multi-Institutional Trial. J Clin Oncol. 2023 Jun 10;41(17):3203-3216. doi: 10.1200/JCO.22.02390. Epub 2023 Apr 27.

    PubMed 37104748

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bicalutamide, flutamide and LHRH agonist (antagonist) therapy in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 518 sites in 2 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 18 inclusion and 19 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: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 518 sites in United States, Canada. 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 6 Oct 2022). 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?

Percentage of Participants Alive (Overall Survival) (time frame: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.). 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 NCT00936390, which also lists 1 linked publication.

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 6 Mar 2026.

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