RTOG 9601 — Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer

Phase 3 · 2017 · Prostate Cancer

Design

Randomized double-blind phase 3 trial of salvage radiotherapy plus 24 months of bicalutamide (150 mg daily) versus salvage radiotherapy plus placebo after radical prostatectomy.

Population

760 men with pT2-T3 N0 prostate cancer and detectable/rising PSA (0.2-4.0 ng/mL) after radical prostatectomy.

Primary Endpoint

Overall survival

Key Result

Adding 24 months of bicalutamide to salvage radiotherapy improved 12-year overall survival from 71.3% to 76.3% (HR for death 0.77, 95% CI 0.59-0.99, P=0.04) and reduced prostate-cancer death (5.8% vs 13.4%).

Guideline Impact

Supports adding hormonal therapy to salvage radiotherapy (NCCN, AUA/ASTRO/SUO guidelines)