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
- (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.
- 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