Clinical trialNCT00002874CompletedPhase 3Interventional

Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy

SponsorRadiation Therapy Oncology GroupEnrollment840Prostate Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

David J Grignon, MD
Indiana University, Indianapolis
Study Chair
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Himanshu R Lukka, MD
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON
Study Chair
clinicaltrials.gov ↗
Niall M Heney, MD
Massachusetts General Hospital and Harvard Medical School, Boston
Study Chair
clinicaltrials.gov ↗
Pierre P Major, MD
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON
Study Chair
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William U. Shipley, MD
Massachusetts General Hospital and Harvard Medical School, Boston
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

240 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
Chus-Hopital Fleurimont
Fleurimont, Quebec, Canada
Centre Hospitalier de L'Universite de Montreal
Montreal, Quebec, Canada
Mcgill University
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada

United States

University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States
Huntsville Hospital System
Huntsville, Alabama, United States
Mbccop - Gulf Coast
Mobile, Alabama, United States
Alabama Oncology, Llc
Montgomery, Alabama, United States
Radiation Oncology Associates of West Alabama
Tuscaloosa, Alabama, United States
Foundation for Cancer Research and Education
Phoenix, Arizona, United States
Mount Diablo Medical Center
Concord, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
California Cancer Center
Fresno, California, United States
Saint Agnes Cancer Center
Fresno, California, United States
Sutter Health West Cancer Research Group
Greenbrae, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States
Jonsson Comprehensive Cancer Center, Ucla
Los Angeles, California, United States
Usc/norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Ccop - Bay Area Tumor Institute
Oakland, California, United States
Huntington Cancer Center
Pasadena, California, United States
Cancer Care Center
Pomona, California, United States
Radiation Oncology Center - Sacramento
Sacramento, California, United States
Radiation Medical Group, Inc.
San Diego, California, United States

200 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Bicalutamide →Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 28 Feb 1998
Primary completion: 31 Aug 2015
Completion: 20 May 2022
Last update posted: 15 Jun 2022
Registered enrollment: 840
Registry id: NCT00002874

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.