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