PURPOSE: We studied the long-term efficacy and tolerability of nilutamide, a nonsteroidal antiandrogen, combined with orchiectomy in patients with advanced prostate cancer. MATERIALS AND METHODS: A large double-blind trial was done on 457 patients randomized to receivenilutamide or placebo after orchiectomy. RESULTS: At 8.5 years of followup significant benefits were found for progression and survival in favor of patients receiving nilutamide and orchiectomy. In addition, normalized prostate 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 normal prostate specific antigen levels at 3 months. Nilutamide was well tolerated in the long term with no increase in the incidence of drug specific adverse events. CONCLUSIONS: With long-term followup of patients with advanced prostate cancer, the combination of nilutamide and orchiectomy has significant benefits in interval to progression and improved survival compared to orchiectomy and placebo.
RCT Entities:
PURPOSE: We studied the long-term efficacy and tolerability of nilutamide, a nonsteroidal antiandrogen, combined with orchiectomy in patients 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 significant benefits were found for progression and survival in favor of patients receiving nilutamide and orchiectomy. In addition, normalized prostate 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 normal prostate specific antigen levels at 3 months. Nilutamide was well tolerated in the long term with no increase in the incidence of drug specific adverse events. CONCLUSIONS: With long-term followup of patients with advanced prostate cancer, the combination of nilutamide and orchiectomy has significant benefits in interval to progression and improved survival compared to orchiectomy and placebo.
Authors: William D Figg; Michael E Franks; David Venzon; Paul Duray; Michael C Cox; W Marston Linehan; W Van Bingham; James A Eastham; Eddie Reed; Oliver Sartor Journal: World J Urol Date: 2004-12-08 Impact factor: 4.226
Authors: Evan Y Yu; Roman Gulati; Donatello Telesca; Peter Jiang; Stephen Tam; Kenneth J Russell; Peter S Nelson; Ruth D Etzioni; Celestia S Higano Journal: J Clin Oncol Date: 2010-04-26 Impact factor: 44.544