RTOG 9601

RTOG 9601 randomised 760 men with a rising PSA after radical prostatectomy to salvage radiotherapy (64.8 Gy) with 24 months of bicalutamide 150 mg or placebo. Twelve-year overall survival was 76.3 percent with bicalutamide and 71.3 percent with placebo (hazard ratio 0.77), with fewer prostate cancer deaths and metastases; the benefit was concentrated in men with PSA above 0.7 ng/mL, and gynaecomastia was common (Shipley and colleagues, New England Journal of Medicine 2017).