This study involved 140 patients with castrate resistant disease. The major focus was on side effects and PSA control over time. 57% of the patients, who had not had chemotherapy showed a >50% decrease in PSA, and 53% of those who had chemo showed a PSA decrease of similar magnitude. A quarter to a third of the patients in the two groups respectively showed PSA decreases of >90%. But the adverse effects were not inconsequential. The most common ones were fatigue (70%), nausea (40%) and constipation (32%). Half the patients had at least one side effect that was rated as severe. Fatigue was rates as such in 14% of the patients.
Higano CS, Beer TM, Taplin ME, Efstathiou E, Hirmand M, Forer D, Scher HI. 2015. Long-term safety and antitumor activity in the phase 1-2 Study of enzalutamide in pre- and post-docetaxel castration-resistant prostate cancer. Eur Urol 68(5):795-801. www.ncbi.nlm.nih.gov/pubmed/25698064