Radiation Oncology/RTOG Trials/9601

RTOG 96-01 (PROSTATE) Title: A Phase III Trial of Radiation Therapy with or without Casodex in Patients with PSA Elevation Following Radical Prostatectomy For pT3N0 Carcinoma of the Prostate Objectives: (1) To compare overall survival outcome of radiation therapy plus Casodex to radiation therapy plus placebo by a randomized trial for patients who, following radical prostatectomy demonstrating pathologic T3 disease and pathologic N0 disease status, have an elevated PSA (either as persistence or as a relapse) and have no evidence of metastatic disease. (2) To compare the treatment with respect to time to second PSA-based progression, time to distant failure, and disease-specific survival. (3) To compare the treatment with respect to time to third PSA failure (or PSA progression on hormonal therapy for second PSA failure) as a potential predictor for impending cancer death. Protocol: Arm 1: 64.8 Gy RT + Casodex x2 years Arm 2: 64.8 Gy RT Eligibility: Status post RP pT3 or (pT2 with +SM) AND post-op PSA 0.2-4 M0 Enrollment Target: 810 patients Activation: March 17, 1998 Closed: March 7, 2003