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