Interim analysis of a randomized phase III study of abiraterone acetate in chemotherapy-naive patients with metastatic castration resistant prostate cancer

In patients with asymptomatic or mildly symptomatic chemotherapy-naive metastatic castration resistant prostate cancer, abiraterone acetate plus prednisone produced a statistically significant benefit in radiographic progression-free survival over placebo plus prednisone, according to a planned interim analysis of the randomized, phase III, multicenter, COUAA-302 study. The results were presented by Dr Charles Ryan of the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, USA at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago (1 - 5 June 2012). With 43% of total events reported in the COUAA-302 study, the independent data monitoring committee concluded that the co-primary endpoints of overall survival and radiographic progression-free survival and secondary endpoints all favored the abiraterone acetate arm and unanimously recommended unblinding the study and crossing patients over from placebo to abiraterone acetate treatment. Read more here.