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Sponsors and Collaborators: |
National Cancer Institute of Canada National Cancer Institute (NCI) Eastern Cooperative Oncology Group Cancer and Leukemia Group B Southwest Oncology Group Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002633 |
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 whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer.
PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: bicalutamide Drug: buserelin Drug: flutamide Drug: goserelin Drug: leuprolide acetate Drug: nilutamide Procedure: orchiectomy Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3-4, N0, M0 Adenocarcinoma of the Prostate |
Estimated Enrollment: | 1200 |
Study Start Date: | March 1995 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This a randomized, multicenter study. Patients are stratified according to center, initial PSA level (less than 20 vs 20-50 vs greater than 50 ng/mL), method of node staging (clinical [no CT scan] vs radiological [CT scan negative] vs surgical), Gleason score (less than 8 vs 8-10), prior hormonal therapy (excluding orchiectomy) (yes vs no), and choice of hormonal therapy (bilateral orchiectomy with or without antiandrogen vs luteinizing hormone-releasing hormone [LHRH] with antiandrogen). Patients are randomized to 1 of 2 treatment arms.
Hormonal therapy on both arms continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on the last day of radiotherapy, at 6 months, and then every 6 months thereafter.
Patients are followed at 1, 2, and 6 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 1,200 patients will be accrued for this study within 7.5 years.
Ages Eligible for Study: | up to 79 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven locally advanced adenocarcinoma of the prostate, defined as 1 of the following:
Pelvic lymph nodes must be clinically negative
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Prior hormonal therapy within the past 12 weeks allowed provided the following conditions are met:
Radiotherapy:
Surgery:
Other:
United States, Alabama | |
East Alabama Medical Center | |
Opelika, Alabama, United States, 36801-5452 | |
United States, Hawaii | |
Tripler Army Medical Center | |
Honolulu, Hawaii, United States, 96859 | |
United States, Illinois | |
Good Samaritan Regional Health Center | |
Mt. Vernon, Illinois, United States, 62864 | |
Saint Anthony's Hospital at Saint Anthony's Health Center | |
Alton, Illinois, United States, 62002 | |
United States, Louisiana | |
Feist-Weiller Cancer Center at Louisiana State University Health Sciences | |
Shreveport, Louisiana, United States, 71130-3932 | |
Veterans Affairs Medical Center - Shreveport | |
Shreveport, Louisiana, United States, 71101 | |
United States, Missouri | |
CCOP - St. Louis-Cape Girardeau | |
St. Louis, Missouri, United States, 63141 | |
David C. Pratt Cancer Center at St. John's Mercy | |
Saint Louis, Missouri, United States, 63141 | |
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | |
Gape Girardeau, Missouri, United States, 63701 | |
St. Francis Medical Center | |
Cape Girardeau, Missouri, United States, 63701 | |
United States, Texas | |
Cancer Therapy and Research Center | |
San Antonio, Texas, United States, 78229 | |
University Hospital - San Antonio | |
San Antonio, Texas, United States, 78229 | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78284-7811 | |
Veterans Affairs Medical Center - San Antonio (Murphy) | |
San Antonio, Texas, United States, 78209 | |
United States, Virginia | |
Sentara Cancer Institute at Sentara Norfolk General Hospital | |
Norfolk, Virginia, United States, 23507 | |
United Kingdom, Wales | |
Velindre Cancer Center at Velindre Hospital | |
Cardiff, Wales, United Kingdom, CF14 2TL |
Study Chair: | Padraig R. Warde, MB, MRCPI, FRCPC | Princess Margaret Hospital, Canada |
Study Chair: | Richard R. Whittington, MD | University of Pennsylvania |
Study Chair: | Srinivasan Vijayakumar, MD | Michael Reese Hospital and Medical Center |
Study Chair: | Patricia Lillis-Hearne, MD | Brooke Army Medical Center |
Study Chair: | Malcolm D. Mason, MD | Velindre NHS Trust |
Study ID Numbers: | CDR0000064065, CAN-NCIC-PR3, CALGB-9593, ECOG-JPR03, MRC-PR07, SWOG-JPR3, EU-99013, NCI-T94-0110O, ISRCTN24991896 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002633 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
Buserelin Prostatic Diseases Genital Neoplasms, Male Nilutamide Leuprolide Goserelin |
Bicalutamide Urogenital Neoplasms Flutamide Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Pharmacologic Actions |
Neoplasms Androgen Antagonists Neoplasms by Site Fertility Agents, Female Therapeutic Uses Fertility Agents |