The Food & Drug Administration recently approved a novel drug for treating men diagnosed with prostate cancer. Investigators from the University of Colorado now suggest that this drug treatment known as abiraterone acetate extends the lives of advanced prostate cancer patients by approximately four months. It may be generally very well tolerated, but leads to few side effects.
The multi-center Phase III clinical trial was conducted on 1195 prostate cancer patients. The study focused on examining the effectiveness of treating patients who had received prior chemotherapy with a combination of abiraterone acetate (Zytiga) and prednisone. Participants were randomly assigned to either receive abiraterone acetate and prednisone or a placebo plus prednisone each day. The treatment continued until the cancer progressed, there were unfavorable reactions, a new treatment was initiated or the patient withdrew from the trial.
Participants taking abiraterone acetate reportedly lived about four months longer than those on the placebo. Thomas W. Flaig, MD, medical oncologist at the University of Colorado Hospital’s Tony Grampsas Urologic Oncology Clinic and assistant professor at the University of Colorado School of Medicine and colleagues also mention that more patients receiving abiraterone acetate experienced a significant drop in the PSA blood level than those on the placebo. Although the tablet has few side effects, careful medical attention seems to be necessary for keeping a tab on specific potential side effects including liver blood test changes, low potassium levels, leg swelling and high blood pressure.
The study was published in the May 26, 2011 issue of the New England Journal of Medicine.