Radiation Oncology/RTOG Trials/9601

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  • 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