Total androgen blockade with the use of orchiectomy and nilutamide (Anandron) or placebo as treatment of metastatic prostate cancer. Anandron International Study Group.

The efficacy of total androgen blockade using orchiectomy and nilutamide was compared with orchiectomy with placebo in a large double-blind clinical trial with 457 patients. The median interval to objective progression was 20.8 months for total androgen blockade and 14.7 months for orchiectomy alone (P = 0.0041). The median interval to death for all patients was 37.1 months versus 29.8 months (P = 0.041). Decrease in pain was seen at months 1, 3, and 6 in a significant percentage for the total androgen blockade group. A significant difference in prostate specific antigen levels was seen at months 3 and 6, with normalization of 75% and 28%, respectively, in both groups at both times. The tolerance of the nonsteroidal antiandrogen nilutamide showed visual disturbances as a side-effect, resulting in the withdrawal of five patients from treatment. Liver and lung disturbances were transient. Total androgen blockade is a more effective treatment for metastatic prostate cancer than orchiectomy alone in this study population.

RCT Entities:   Population Interventions Outcomes