Radiation Oncology/RTOG Trials/9608

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  • Title: A Phase III Trial of Total Androgen Suppression vs. Total Androgen Suppression Plus Definitive External Beam Irradiation for Pathologic Lymph Node Positive (pN+) Adenocarcinoma of the Prostate
  • Objectives:
    • (1) To test the results of the addition of pelvic radiation therapy to TAS in patients with lymph-node positive adenocarcinoma of the prostate. Endpoints of overall survival, disease specific survival, and disease free survival will be addressed.
    • (2) To assess the differences in toxicity with the addition of pelvic radiation therapy to TAS. Endpoints of gastrointestinal toxicity and genitourinary toxicity will be utilized.
  • Protocol:
    • Arm 1: Total Androgen Suppression indefinitely
    • Arm 2: Total Androgen Suppression indefinitely + EBRT whole pelvis to 50.4 Gy with boost to prostate to 68.4 Gy - 70.2 Gy
  • Eligibility: pN+ and PSA >4
  • Enrollment Target: 750 patients
  • Activation: July 1, 1997
  • Closed: September 23, 1998