AzTrials
AzTrials

Prostate CancerPhase 3NCT00005044

Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

A Phase 3 study testing Casodex, Eulexin and LHRH agonist in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 261 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: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Casodex, Eulexin and LHRH agonist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,579 participants
Where
261 sitesin 2 countries
Study dates
Feb 2000to 20 May 2022
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 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adenocarcinoma of prostatic origin histologically-confirmed within 180 days of the randomization date.
  • Zubrod Performance Status 0-1 (Appendix II).
  • Prostatic biopsy tumor grading by the Gleason Score classification (Appendix VI) is mandatory prior to randomization.
  • Patients at intermediate risk for disease relapse as determined by any of the following combinations of factors (NOTE: tumor found in one or both lobes on biopsy, but not palpable, will not alter T stage):
  • Clinical stage T1b-4, Gleason score 2-6, and prostate-specific antigen >10 but ≤ 100.
  • Clinical stage T1b-4, Gleason score 7, and prostate-specific antigen < 20.
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  • Clinical stage T1b-1c, Gleason score 8-10, and prostate-specific antigen <20.
  • Clinically negative (N0) lymph nodes (LN) as established by imaging (pelvic ± abdominal CT, MRI or LAG), or negative LN by nodal sampling or dissection (laparoscopy or laparotomy). Patients with radiologic (e.g., CT, MRI or LAG) or radioimmunoscintigraphy (i.e., ProstaScint™) findings suggestive of regional nodal involvement are eligible if cytologic (e.g., needle aspiration) or histologic (e.g., surgical sampling) evaluation shows no evidence of a neoplastic process (i.e., prostatic or non-prostatic malignancy). Patients with equivocal radiologic findings (maximum nodal size ≤ 1.5 cm) are eligible.
  • No distant (M0) metastases. Patients with radionuclide imaging (e.g., bone scintigraphy, ProstaScint™) findings suggestive, but not diagnostic of metastatic disease are eligible if radiologic (e.g., standard or tomographic radiography, or CT/MRI) imaging does not confirm metastatic disease.
  • Pretherapy serum (total) prostate-specific antigen value performed with a Federal Drug Administration approved assay method, e.g. Abbott, Hybritech, etc.
  • Treatment must begin within 6 weeks after randomization.
  • Alanine aminotransferase (ALT) must be within 2 x upper normal limit.
  • Patients must sign a study-specific informed consent form (Appendix I) prior to randomization.

Who cannot join

  • Patients at high risk for disease relapse as determined by either:
  • Prostate-specific antigen ≥ 20 and Gleason score ≥ 7 (any T stage).
  • Clinical stage ≥T2 and Gleason score ≥ 8 (any prostate-specific antigen).
  • Patients at low risk for disease relapse as determined by:
  • Clinical stage ≤T2, Gleason score ≤ 6, and prostate-specific antigen ≤ 10.
  • Clinical stage Tx, T0, or T1a.
Show all 19Show fewer
  • Histologic or radiologic evidence of tumor involvement of regional lymph nodes (N1) or the presence of metastatic disease (M1).
  • Pretherapy serum prostate-specific antigen level > 100.
  • Co-morbid medical illness which in the opinion of the investigator is expected to result in a life expectancy of <10 years.
  • Any of the following prior therapies:
  • Pelvic external beam radiation therapy.
  • Radionuclide prostate brachytherapy.
  • Prostatectomy or prostatic cryosurgery.
  • Prior bilateral orchiectomy.
  • Prior androgen suppression therapy; however, patients begun on LHRH agonist therapy remain eligible if (1) LHRH agonists were started no more than 30 days before randomization, and (2) Casodex or Eulexin was (or will be) started no more than 14 days before or after the date that the LHRH agonist injection was given. Any finasteride therapy administered for prostatic hypertrophy must be discontinued.
  • Chemotherapy for prostatic carcinoma.
  • Previous or concomitant invasive cancer, other than localized basal cell or squamous cell skin carcinoma (AJCC Stage 0-II), unless continually disease free for at least 5 years.
  • Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up.
  • The patient's participation in another medical research study that involves prostate cancer treatment.

Trial locations and contacts

261 sites in 2 countries.

261 sites in 2 countries

United States241 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Akron General Medical Center

    Akron, Ohio, 44302

  • Akron City Hospital

    Akron, Ohio, 44304

  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • Radiation Oncology Associates of Albuquerque

    Albuquerque, New Mexico, 87109

  • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • St. John's Medical Center

    Anderson, Indiana, 46016

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0010

  • Anne Arundel Oncology Center

    Annapolis, Maryland, 21401

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center and Cancer Center

    Baltimore, Maryland, 21204

  • Harbor Hospital Center

    Baltimore, Maryland, 21215-1290

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • St. Agnes Cancer Center

    Baltimore, Maryland, 21229

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Bloomington Hospital

    Bloomington, Indiana, 47402

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02114

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York, 11203

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont, 05405-0075

  • Cooper Cancer Institute

    Camden, New Jersey, 01803

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Cancer Center at Christ Hospital

    Cincinnati, Ohio, 45219

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45219

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Finger Lakes Radiation Oncology Center

    Clifton Springs, New York, 14432

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Medical Center/John B. Amos Community Cancer Center

    Columbus, Georgia, 31901

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • Mount Diablo Medical Center

    Concord, California, 94524-4110

  • Batte Cancer Center at Northeast Medical Center

    Concord, North Carolina, 28025

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Denver, Colorado, 80010

  • CCOP - Colorado Cancer Research Program, Incorporated

    Denver, Colorado, 80224

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Wendt Regional Cancer Center of Finley Hospital

    Dubuque, Iowa, 52001

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07019

  • Pocono Cancer Center

    East Stroudsburg, Pennsylvania, 18301

  • St. Elizabeth Medical Center

    Edgewood, Kentucky, 41017

  • John F. Kennedy Medical Center

    Edison, New Jersey, 08818

  • Trinitas Hospital - Jersey Street Campus

    Elizabeth, New Jersey, 07201

  • Hurley Medical Center

    Flint, Michigan, 48503

  • McLaren Regional Cancer Center

    Flint, Michigan, 48532-3685

  • 21st Century Oncology - Fort Myers

    Fort Myers, Florida, 33901-8082

  • California Cancer Center

    Fresno, California, 93720

  • Saint Agnes Cancer Center

    Fresno, California, 93720

  • Shands Cancer Center at the University of Florida Health Science Center

    Gainesville, Florida, 32610-0385

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0209

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502-1628

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54301

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-3508

  • Sutter Health Western Division Cancer Research Group

    Greenbrae, California, 94904

  • Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina

    Greenville, North Carolina, 27835-6028

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • RMH Regional Cancer Center

    Harrisonburg, Virginia, 22801

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Comprehensive Cancer Institute

    Huntsville, Alabama, 35801

  • Huntsville Hospital

    Huntsville, Alabama, 35807

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202

  • Methodist Cancer Center at Methodist Hospital

    Indianapolis, Indiana, 46206-1367

  • Community Regional Cancer Care

    Indianapolis, Indiana, 46219

  • West Tennessee Cancer Center at Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • Florida Radiation Oncology Group

    Jacksonville, Florida, 32207

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts, 02130

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236-5300

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Norris Cotton Cancer Center at Dartmouth Medical School

    Lebanon, New Hampshire, 03756-0002

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0293

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Veterans Affairs Medical Center - Long Beach

    Long Beach, California, 90822

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1714

  • James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Louisville Radiation Oncology Center at Caritas Regional Cancer Center

    Louisville, Kentucky, 40215

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

  • Southern Wisconsin Radiotherapy Center

    Madison, Wisconsin, 53713

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • Merle M. Mahr Cancer Center

    Madisonville, Kentucky, 42431

  • Elliot Regional Cancer Center

    Manchester, New Hampshire, 03103

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Marquette General Hospital

    Marquette, Michigan, 49855

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Holmes Regional Medical Center

    Melbourne, Florida, 32901-3276

  • Community Memorial Hospital

    Menomonee Falls, Wisconsin, 53051

  • University of Miami Sylvester Cancer Center

    Miami, Florida, 33136

  • Baptist Hospital of Miami

    Miami, Florida, 33256-2110

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • MidMichigan Medical Center - Midland

    Midland, Michigan, 48670

  • South Jersey Regional Cancer Center

    Millville, New Jersey, 08332

  • Columbia Hospital

    Milwaukee, Wisconsin, 53211

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • Fairview University Medical Center - University Campus

    Minneapolis, Minnesota, 55455

  • Trinity Cancer Care Center

    Minot, North Dakota, 58701

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36607

  • Montgomery Cancer Center

    Montgomery, Alabama, 36106-3657

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital

    Mount Holly, New Jersey, 08060

  • Ball Memorial Hospital Cancer Center

    Muncie, Indiana, 47303-3499

  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

    Nashville, Tennessee, 37232-5671

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Hospital of St. Raphael

    New Haven, Connecticut, 06511

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8040

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112-2699

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Beth Israel Medical Center - Philipps Ambulatory Care Center

    New York, New York, 10003

  • Herbert Irving Comprehensive Cancer Center at Columbia University

    New York, New York, 10032

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • Frank C. Love Cancer Institute at St. Anthony Hospital

    Oklahoma City, Oklahoma, 73102

  • Oklahoma University Medical Center at University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

    Omaha, Nebraska, 68114-4199

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7521

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806-2134

  • Bay Medical Center

    Panama City, Florida, 32401

  • Gulf Coast Cancer Treatment Center

    Panama City, Florida, 32405-4587

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068

  • Parma Community General Hospital

    Parma, Ohio, 44129

  • Huntington Cancer Center at Huntington Hospital

    Pasadena, California, 91105

  • Bayshore Medical Center

    Pasadena, Texas, 77504

  • NSMC Cancer Center

    Peabody, Massachusetts, 01960

  • CCOP - Scott and White Hospital

    Peoria, Illinois, 61602

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Abramson Cancer Center at University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104-4283

  • Veterans Affairs Medical Center - Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141-3098

  • Foundation for Cancer Research and Education

    Phoenix, Arizona, 85013

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Mercy Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15219

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15236

  • Champlain Valley Physicians Hospital Medical Center

    Plattsburgh, New York, 12901-1490

  • Robert and Beverly Lewis Family Cancer Care Center

    Pomona, California, 91767

  • Atlantic City Medical Center

    Pomona, New Jersey, 08240

  • Maine Medical Center

    Portland, Maine, 04102

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Naval Medical Center, Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Medical Center of Princeton

    Princeton, New Jersey, 08540

  • Roger Williams Medical Center

    Providence, Rhode Island, 02908-4735

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • All Saints Cancer Center at All Saints Healthcare

    Racine, Wisconsin, 53405

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57709

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Bon Secours - St. Mary's Hospital

    Richmond, Virginia, 23226

  • Massey Cancer Center at Virginia Commonwealth University

    Richmond, Virginia, 23298-0058

  • Valley Hospital

    Ridgewood, New Jersey, 07450

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905-0001

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Regional Radiation Oncology Center at Rome

    Rome, Georgia, 30165

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • William Beaumont Hospital - Royal Oak

    Royal Oak, Michigan, 48073

  • Radiation Oncology Center - Sacramento

    Sacramento, California, 95816

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84132

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • Radiation Medical Group, Incorporated

    San Diego, California, 92101

  • Naval Medical Center - San Diego

    San Diego, California, 92134-3202

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • O'Connor Hospital

    San Jose, California, 95128

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • Sarasota Radiation and Medical Oncology Center

    Sarasota, Florida, 34233

  • Mercy Hospital Cancer Center - Scranton

    Scranton, Pennsylvania, 18501

  • Cancer Institute at Virginia Mason Medical Center

    Seattle, Washington, 98111

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • Somerset Medical Center

    Somerville, New Jersey, 08876

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Deaconess Medical Center

    Spokane, Washington, 99204

  • Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • St. Louis University Hospital Cancer Center

    St Louis, Missouri, 63110-0250

  • Mallinckrodt Institute of Radiology

    St Louis, Missouri, 63110

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13217

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43623-3456

  • Community Medical Center

    Toms River, New Jersey, 08755

  • Torrance Memorial Medical Center

    Torrance, California, 90505

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • Fox Chase Cancer Center at St. Francis Medical Center

    Trenton, New Jersey, 08629

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48085

  • St. John Health System

    Tulsa, Oklahoma, 74104

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • DCH Cancer Treatment Center

    Tuscaloosa, Alabama, 35401

  • Associated Radiologists, P.A.

    Warren Township, New Jersey, 07059

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Waukesha Memorial Hospital Regional Cancer Center

    Waukesha, Wisconsin, 53188

  • Schiffler Cancer Center

    Wheeling, West Virginia, 26003

  • Wilkes-Barre General Hospital

    Wilkes-Barre, Pennsylvania, 18764-0001

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

  • Riverhill Radiation Oncology

    Yonkers, New York, 10701

  • Wellspan Health - York Cancer Center

    York, Pennsylvania, 17403

Other trials in United States

Canada20 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Northeastern Ontario Regional Cancer Centre - Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Kingston Regional Cancer Centre

    Kingston, Ontario, K7L 5P9

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Doctor Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L 4MI

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Northwestern Ontario Regional Cancer Care

    Thunder Bay, Ontario, P7B 6V4

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer

RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of moderate-duration (28 weeks) neoadjuvant total androgen suppression (TAS) and radiotherapy (RT) with short-duration (8 weeks) neoadjuvant TAS and RT, as related to disease-specific survival, in patients with intermediate-risk adenocarcinoma of the prostate.
  • Compare these regimens, in terms of overall survival, disease-free survival, time to local tumor progression or distant failure, time to first biochemical failure, hormone-refractory state, and treatment-induced morbidity, in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prostate-specific antigen level (no greater than 10 ng/mL vs greater than 10 but no greater than 20 ng/mL vs greater than 20 ng/mL), tumor stage (T1b-2 vs T3-4), Gleason score (2-4 vs 5-6 vs 7-10), and prior hormonal therapy (yes vs no). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive total androgen suppression for 8 weeks prior to the initiation of radiotherapy and throughout radiotherapy. A luteinizing hormone-releasing hormone (LHRH) agonist is administered every 1-3 months AND bicalutamide OR flutamide is given orally daily for a total duration of 16 weeks. Beginning with week 9, patients undergo radiotherapy 5 days a week for 8 weeks.
  • Arm II: Patients receive total androgen suppression for 28 weeks prior to the initiation of radiotherapy and throughout radiotherapy. An LHRH agonist AND bicalutamide OR flutamide are administered as in arm I for a total duration of 36 weeks. Beginning with week 29, patients undergo radiotherapy as in arm I.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,540 patients (770 per treatment arm) will be accrued for this study within 4 years.

Conditions
Prostate Cancer
Being tested
Casodex, Eulexin, LHRH agonist, radiation therapy
Keywords
adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III 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.

  • CasodexDrug

    Also called bicalutamide

    Orally at a dose of one 50 mg tablet per day started within (before or after) 14 days of the first LHRH agonist injection.

  • EulexinDrug

    Also called flutamide

    Orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg (six capsules) started within (before or after) 14 days of the first LHRH agonist injection.

  • LHRH agonistDrug

    Also called Zoladex, Lupron, Eligard, Viadur

    LHRH agonist of choice. The manufacturer's instructions should be followed.

  • radiation therapyRadiation

    [Prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin receives 70.2 Gy (1.8 Gy/day x 39 fractions, five days/week)] OR [regional nodes, prostate and seminal vesicles + 1.0-1.5 cm margin will receive 46.8 Gy (1.8 Gy/day x 26 fractions, five days/week), followed by a 23.4 Gy (1.8 Gy/day x 13 fractions, five days/week) boost to the prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin]

Study groups in NCT00005044
Study groupRoleWhat they receive
TAS x 8 weeksExperimentalTotal Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
Receives: Drug: Casodex; Drug: Eulexin; Drug: LHRH agonist; Radiation: radiation therapy
TAS x 28 weeksExperimentalTAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
Receives: Drug: Casodex; Drug: Eulexin; Drug: LHRH agonist; Radiation: radiation therapy

What is being measured

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

  1. Disease-specific Survival (DSS) (10-year Rates Reported)

    Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy. Death due to other causes is considered a competing risk. All others are censored. DSS is estimated using the cumulative incidence method. Ten-year rate is reported.

    Measured: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

Secondary outcomes (6)

  1. Overall Survival (OS) (10-year Rates Reported)

    Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.

    Measured: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

  2. Disease-free Survival (DFS) (10-year Rates Reported)

    Disease-free survival time is defined as time from randomization to the date of disease progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.

    Measured: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

  3. Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported)

    Time to distant metastasis measured from date of randomization to date of documented distant metastasis; competing risks are BF, LRP, and death without DM; all others are censored. Time to locoregional progression measured from date of randomization to date of documented local or regional progression; competing risks are BF [protocol definition- first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy], DM, and death without LRP; all others are censored. LRP and DM are estimated using the cumulative incidence method. Ten -year rates are reported.

    Measured: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

  4. Time to First Biochemical Failure (BF) (10-year Rates Reported)

    Protocol definition: Time to BF measured from date of randomization to first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored.

    Phoenix definition: Time to BF measured from date of randomization to first of (1) the date of documented rise of 2 ng/ml above the post-treatment(RT end date) nadir or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. For both definitions BF is estimated using the cumulative incidence method. Ten year rates reported.

    Measured: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

  5. Time to Second Biochemical Failure (SBF) (10-year Rates Reported)

    Time to SBF measured from date of randomization to the date of PSA increase of ≥1.0 ng/mL (from the nadir PSA after completion of protocol-specified therapy) after salvage androgen suppression was started; competing risks LRP, DM, and death without SBF; all others are censored. SBF is estimated using the cumulative incidence method. Ten-year rates are reported.

    Measured: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

  6. Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)

    Acute drug therapy and radiation (<= 90 days from start of RT) toxicity was graded using the Common Toxicity Criteria (CTC) v.2.0 criteria; late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring schema. Grade refers to the severity of the toxicity. The CTC v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild toxicity, Grade 2 Moderate toxicity, Grade 3 Severe toxicity, Grade 4 Life-threatening or disabling toxicity, Grade 5 Death related to toxicity. The highest grade acute and late toxicity was determined for each patient.

    Measured: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2000
  3. Primary completionSep 2012
  4. Study completion20 May 2022

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
1,579 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005044
Sponsor's protocol ID
RTOG-9910
Other IDs
CDR0000067635
Status last verified
May 2022
First submitted
6 Apr 2000
Last updated
15 Jun 2022
Data monitoring committee
Yes

Publications

  • Pisansky TM, Hunt D, Gomella LG, Amin MB, Balogh AG, Chinn DM, Seider MJ, Duclos M, Rosenthal SA, Bauman GS, Gore EM, Rotman MZ, Lukka HR, Shipley WU, Dignam JJ, Sandler HM. Duration of androgen suppression before radiotherapy for localized prostate cancer: radiation therapy oncology group randomized clinical trial 9910. J Clin Oncol. 2015 Feb 1;33(4):332-9. doi: 10.1200/JCO.2014.58.0662. Epub 2014 Dec 22.

    PubMed 25534388

  • Spratt DE, Tang S, Sun Y, Huang HC, Chen E, Mohamad O, Armstrong AJ, Tward JD, Nguyen PL, Lang JM, Zhang J, Mitani A, Simko JP, DeVries S, van der Wal D, Pinckaers H, Monson JM, Campbell HA, Wallace J, Ferguson MJ, Bahary JP, Schaeffer EM, Sandler HM, Tran PT, Rodgers JP, Esteva A, Yamashita R, Feng FY. Artificial Intelligence Predictive Model for Hormone Therapy Use in Prostate Cancer. NEJM Evid. 2023 Aug;2(8):EVIDoa2300023. doi: 10.1056/EVIDoa2300023. Epub 2023 Jun 29.

    PubMed 38320143

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Casodex, Eulexin and LHRH agonist in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 261 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 13 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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 261 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 31 Oct 2017). 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?

Disease-specific Survival (DSS) (10-year Rates Reported) (time frame: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)). 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 NCT00005044, which also lists 2 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 15 Jun 2022.

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