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 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.