LONG-TERM EFFICACY AND SAFETY OF NILUTAMIDE PLUS CASTRATION IN ADVANCED PROSTATE-CANCER, AND THE SIGNIFICANCE OF EARLY PROSTATE-SPECIFIC ANTIGEN NORMALIZATION

Purpose: We studied the long-term efficacy and tolerability of nilutam ide, a nonsteroidal antiandrogen, combined with orchiectomy in patient s with advanced prostate cancer. Materials and Methods: A large double -blind trial was done on 457 patients randomized to receive nilutamide or placebo after orchiectomy. Results: At 8.5 years of followup signi ficant benefits were found for progression and survival in favor of pa tients receiving nilutamide and orchiectomy. In addition, normalized p rostate specific antigen levels at 3 months from the start of therapy were predictive of good long-term outcome. Moreover, combined androgen blockade with nilutamide increased the chance of patients having norm al prostate specific antigen levels at 3 months. Nilutamide was well t olerated in the long term with no increase in the incidence of drug sp ecific adverse events. Conclusions: With long-term followup of patient s with advanced prostate cancer, the combination of nilutamide and orc hiectomy has significant benefits in interval to progression and impro ved survival compared to orchiectomy and placebo.