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

Study start date: October 1, 1994

Inclusion criteria: Histologically confirmed locally confined adenocarcinoma of the prostate with primary tumors confined to the prostate, clinical stage T1b,1c, 2a or 2b. Negative nodes evaluated by imaging methods (classified in the study as NX) or by surgical sampling (classified in the study as N0). Karnofsky performance status ≥ 70. PSA is mandatory, must be ≤ 20) No prior hormonal therapy, radiation or chemotherapy. Prior finasteride for prostate hypertrophy allowed if discontinued at least 60 days prior to randomization. Prior testosterone administration allowed if at least 90 days elapsed since last administration. No evidence of distant metastasis or other synchronous primary. Patients with prior invasive malignancy who were disease free for at least 5 years could be eligible with pre-randomization approval by the study chairman. Treatment begins within 21 days after randomization. Patients signs a study-specific informed consent form. Alanine Aminotransferase (ALT) within 2x upper normal limits. Exclusion criteria: Stage T1a or ≥ T2c disease. Lymph node involvement (N1 - N3). Evidence of distant metastasis. (M1) PSA > 20. Radical surgery or cryosurgery for carcinoma of the prostate, previous irradiation, antiandrogen therapy or chemotherapy. Previous or concurrent cancers other than basal cell or squamous cell skin carcinoma. Patients with squamous cell carcinomas required to be NED (no evidence of disease) for a minimum of two years prior to study entry. Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up. Karnofsky performance status of < 70.