LAUSR

Experts’ summary: This prospective, double-blind, controlled study investigated the effect of combining antiandrogen therapy with salvage radiation therapy (sRT) for biochemical recurrence (prostatespecific antigen [PSA] between 0.2 and 4.0 ng/ml) on overall survival (OS). A total 760 eligible patients who were previously treated with radical prostatectomy (RP) and pelvic lymphadenectomy for localized prostate cancer were included. Median PSA at inclusion was 0.6 ng/ml. Patients were treated between 1998 and 2003 with 68.8 Gy on the prostate bed plus 150 mg of bicalutamide or placebo for 2 yr. The treatment arm showed a significant increase in 12-yr OS compared to the placebo arm (76.3% vs 71.3%; hazard ratio [HR] 0.77; p = 0.04; number needed to treat [NNT] 20). Moreover, at 12 yr the rated of death from prostate cancer (5.8% vs 13.4%, HR 0.49; p < 0.001; NNT 13), occurrence of metastasis (14.5% vs 23%, HR 0.48; p < 0.001; NNT 5) and second biochemical failure (44% vs 67.9%, HR 0.48; p < 0.001; NNT 4.2) were all lower in the bicalutamide group. Subgroup analyses showed that patients with aggressive disease experienced the most benefit from combination therapy. The most common adverse event reported was gynecomastia (69.7% in the bicalutamide arm vs 10.9% in the placebo arm).