Investigational agent improves overall survival in men with metastatic PCa

October 28, 2010

Patients treated with the investigational agent abiraterone acetate plus low-dose prednisone/prednisolone showed a significant improvement in overall survival compared with those treated with prednisone/prednisolone plus placebo, according to results from an interim analysis of a randomized, placebo-controlled phase III study.

Patients treated with the investigational agent abiraterone acetate plus low-dose prednisone/prednisolone showed a significant improvement in overall survival compared with those treated with prednisone/prednisolone plus placebo, according to results from an interim analysis of a randomized, placebo-controlled phase III study.

The study included 1,195 patients with metastatic advanced prostate cancer previously treated with one or two chemotherapy regimens, at least one of which contained docetaxel (Taxotere). Results of the study were presented at the European Society for Medical Oncology annual congress in Milan, Italy.

Treatment with abiraterone resulted in a 35% reduction in the risk of death (HR=0.65; 95% CI: 0.54, 0.77; pppp

"Abiraterone acetate has the potential to meet a significant unmet need, so this news will be incredibly important to prostate cancer patients and their families," said Johann S. de Bono, MD, PhD, of the Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, and one of the study’s lead investigators. "We are very pleased with the definitive results of this rigorous study, which show that abiraterone acetate may extend survival for men with metastatic advanced prostate cancer that progressed after treatment with docetaxel."

Based on the results of the trial, manufacturer Centocor Ortho Biotech, Inc. plans to file marketing applications for abiraterone with regulatory authorities in the U.S. and Europe by the end of the year.

Dr. de Bono disclosed financial interest or other relationship with AstraZeneca, Genentech, Johnson & Johnson, Medivation, Merck, and Pfizer.

Look for more details on this study in an upcoming issue of Urology Times.