Radiation Oncology/RTOG Trials/9608

RTOG 96-08 (PROSTATE) 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