Drug treatment extends lives of men with prostate cancer

(Medical Xpress) -- A drug recently approved by the Food & Drug Administration for the treatment of prostate cancer is proving to give some patients the gift of time.

A new study shows abiraterone acetate extends the lives of men with the most advanced form of the disease by about four months. The study in the May 26, 2011 issue of the New England Journal of Medicine was co-authored by 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.

“Abiraterone acetate is a new, life-extending pill for the treatment of advanced . Unlike the traditional chemotherapy drugs used in these situations, abiraterone is generally very well tolerated,” said Flaig.

The multi-center Phase III clinical trial of 1195 participants looked at the effectiveness of treating patients who had received prior chemotherapy with a combination of abiraterone acetate (Zytiga) and prednisone. When this trial was initiated, there were no treatments that clearly prolonged survival in this late phase of prostate cancer. The patients were randomized to receive abiraterone acetate plus prednisone or a placebo plus prednisone each day. Treatment continued until the cancer progressed, there were unfavorable reactions, a new treatment was initiated or the patient withdrew from the trial.

The study shows participants taking abiraterone acetate lived about four months longer than participants taking the placebo. In addition, more patients receiving abiraterone acetate experienced a significant drop in the PSA blood level than those on the placebo.

“The survival benefit observed in this study is especially notable, since this was seen in the most advanced cases of prostate cancer,” said Flaig. “Other studies are being done to examine the benefit of using abiraterone acetate earlier in the disease process, where it may be even more effective.”

The FDA approved abiraterone acetate at the end of April. The tablet has few side effects but careful medical attention is required to monitor for specific potential side effects including liver blood test changes, low potassium levels, leg swelling and high blood pressure.


Explore further

Phase 3 trial finds no benefit from atrasentan added to chemo for advanced prostate cancer

Provided by University of Colorado Denver
Citation: Drug treatment extends lives of men with prostate cancer (2011, May 26) retrieved 17 July 2019 from https://medicalxpress.com/news/2011-05-drug-treatment-men-prostate-cancer.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
 shares

Feedback to editors

User comments

May 26, 2011
It seems to me that all the people in the placebo group who died 4 months early died because of the FDA's overly cautious and cowardly policies.

And everyone in the world who died quicker than necessary of prostate cancer during the wait from phase 2 to phase 3 definitely died because of FDA policies.

It also seems to me to be unethical to give dying people placebos to further your scientific goals. After all, we have plenty of data on prostate cancer patients who do not get life extending drugs already. Do we really believe the placebo effect is going to extend the lives of advanced cancer patients by months or years?

A while back, I remember there was a proposal to move drugs treating fatal diseases to market after successful phase 2 trials, then extend testing with data collected during the initial market phase to basically have a live phase 3 test after the launch.

Seems sensible to me, but I guess not to the self serving, risk averse, and cowardly bureaucrats at the FDA.

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more