Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence

OBJECTIVES: * Determine the effect of one year of adjuvant hormonal ablation on disease-free survival at 5 years in node-negative radical prostatectomy patients at high risk for progression. * Determine the effect of this treatment on the incidence of androgen independent prostate cancer and on disease specific and overall survival. * Determine the impact of one year of total androgen ablation on quality of life and serum testosterone levels. * Assess differences in quality of life between wives of patients in the androgen ablation condition compared to wives of patients in the control condition. * Obtain blood samples from patients at high risk for failure post-prostatectomy to evaluate serum markers of prognosis. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. * Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year. * Arm II: Patients receive no initial treatment. Quality of life is assessed every 6 months for 5 years. Quality of life of wives/partners of patients is assessed every 6 months for two years. Patients are followed every 3 months for 1 year and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 496 patients (248 per treatment arm) will be accrued for this study within 3.5 years.