Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.
Drug: goserelin acetate
Drug: leuprolide acetate
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A PHASE III TRIAL OF THE STUDY OF ENDOCRINE THERAPY USED AS A CYTOREDUCTIVE AND CYTOSTATIC AGENT PRIOR TO RADIATION THERAPY IN GOOD PROGNOSIS LOCALLY CONFINED ADENOCARCINOMA OF THE PROSTATE|
- Overall survival [ Time Frame: From date of randomization to death due to any cause ] [ Designated as safety issue: No ]
|Study Start Date:||October 1994|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Neoadjuvant TAS 2 months before and during RT
Neoadjuvant Total Androgen Suppression (TAS) two months before and during radiation therapy
|Drug: flutamide Drug: goserelin acetate Drug: leuprolide acetate Radiation: radiation therapy|
Radiation therapy alone
Radiation therapy alone
|Radiation: radiation therapy|
OBJECTIVES: I. Compare the overall and disease-specific survival and local and/or distant clinical relapse rate in patients with locally confined carcinoma of the prostate treated with goserelin plus flutamide used as cytoreductive agents prior to definitive radiotherapy vs radiotherapy alone. II. Compare these regimens in terms of freedom from prostate specific antigen (PSA) failure, second clinical relapse, and second PSA relapse in these patients. III. Compare prostate rebiopsy results in these patients at 2 years. IV. Determine the effect of goserelin and flutamide therapy on sexual function in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by PSA level (less than 4 vs 4-20), tumor differentiation (good vs moderate vs poor), nodal status (N0 vs Nx), and participating center. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral flutamide 3 times a day and goserelin subcutaneously once every 4 weeks, or once as a time release injection (intramuscular leuprolide may be substituted for goserelin), beginning 2 months prior to radiotherapy and continuing until completion of radiotherapy. Patients undergo radiotherapy daily 4-5 days per week for almost 8 weeks. Arm II: Patients undergo radiotherapy only, as in arm I. Patients are followed every 3 months for the remainder of the first year, every 4 months for 1 year, every 6 months for 3 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 1980 patients will be accrued for this study within 5 years.