A Phase III Randomized Prospective 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.