An announcement from Market Watch claims that Cougar Biotechnology has come to an agreement with the US Food & Drug Administration (FDA) to conduct an additional Phase III trial of abiraterone acetate in prostate cancer.
The currently ongoing and much in demand Phase III trial of abiraterone acetate was designed for prostate cancer survivors who had already failed at least one docetaxel-containing drug regimen (chemotherapy). Many survivors who are not as progressed have been frustrated because this trial was restricted solely to late stage survivors.
This new trial will be enrolling approximately 1,000 chemotherapy-naïve and hormone resistant (castration resistant) survivors. Many of us feel that abiraterone might be able to provide a positive profile for earlier progressed disease than the current trial allows. If this new trial provides a positive result it would offer the potential for FDA approval of abiraterone acetate for use significantly earlier in the course of the disease.
The trial will be a randomized, double-blind, placebo-controlled trial (CB7630) plus prednisone in survivors with metastatic, castration-resistant prostate cancer who have not yet received treatment with chemotherapy. The trial will be randomized (1:1) so that subjects will receive abiraterone acetate plus prednisone or placebo plus prednisone.
Cougar plans on having approximately 150 trial sites in North America, Europe and Australia. Cougar and the FDA have agreed upon multi-primary endpoints of this new trial. The end points will be progression-free survival and overall survival.
The other good news is that according to the announcement, Cougar anticipates starting enrollment survivors into this trial before the end of March 2009.
Joel T Nowak MA, MSW