In an article published in New Eng J Med (2012) the authors describe a placebo controlled trial using enzalutamide in castrate resistant prostate cancer. 1199 men were recruited; two thirds received 160 mg enzalutamide daily while the rest took placebo. The trial was stopped early, after 520 men had died, because a pre-planned analysis showed the drug’s superiority over placebo. Median survival with enzalutamide was 18.4 months, whereas with placebo this was 13.6 months. All the secondary outcomes also favoured the drug. These included the proportion of men in whom levels of prostate specific antigen (PSA) at least halved during the study (54% with enzalutamide v 2% with placebo), quality of life, and time to progression of the disease accompanied by a predefined rise in PSA (8.3 months v 3.0 months).
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