There has been a lot of discussion about a number of “on the horizon” drugs that are designed to aggressively treat advanced prostate cancer, including MDV3100. MDV3100 is supposed to act as a “super” antiandrogen (Casodex is the currently most used antiandrogen in the treatment of advanced prostate cancer).
You may qualify to participate in this phase III trial called PREVAIL if you meet the following criteria:
1- If you have advanced prostate cancer (spread outside the prostate gland).
2- If you have become castrate resistant (your prostate cancer is no longer being controlled
by hormone therapy (ADT).
3- Your prostate cancer does not cause you any pain or just mild pain.
4- You have not yet had any chemotherapy (taxotere or Jevtana)
To find out more about this trial go to (in the United States and Canada)go to:
or call: 855-977-3825
If you live outside of the United States or Canada you should submit a request for more information at information.
If you do live outside the United States or Canada you still may be able to participate in the PREVAIL trial if you meet all the above requirements and are able to travel to one of these
clinical trial locations.
Joel T. Nowak, M.A., M.S.W.
Hi Joel, I found this story frustrating. I don’t understand the clinical trial process. Here’s a drug that has been through phase one and two trials. It is well tolerated and shows the possibility of helping men with advanced prostate cancer. Now it is going through more trials. Why can’t the approval of drugs be more like the process of developing computer programs. A beta version is released for public use. Users are advised it may not work perfectly, may cause problems and are asked to submit their experiences with the beta version. Why can’t drugs that have proven themselves to be basically safe be released for use by patients and their doctors. Clinical trials must be done, of course, but a lot of additional information could be collected from thousands of private trials and the drug companies could recover some of their costs before the drug is approved. Who is being protected by this trial process? The Government trial page says this MDV3100 trial will be finished in 2014. http://clinicaltrials.gov/ct2/show/NCT01212991 How many of us are going to die waiting for this approval? The panel charged with the responsibility of approving drugs should be 50% staffed with cancer patients. Thanks, Ted
Ted, I certainly understand your frustration and anger. You are not alone in your concern. The issue is that phase I and phase II trials are not designed to compare the investigational drug against either a placebo or the current standard of care, so we can not really know the efficacy of the drug. Additionally, the earlier trials have a much smaller sample so they are not adequately powered to be able to make good decisions about either the safety or the efficacy of a drug. What we really need are new bio-markers that would allow us to measure these important issues without having to actually wait for so many additional deaths. – Joel
Good points. I’ve read that Circulating Tumor Counts (CTCs) will possibly be the eventual alternative primary endpoint in clinical trials, instead of patient deaths. This might lead to trials that are much shorter in terms of length of time. Another redesign for prostate cancer trials, should be the re-conceptualization of metastatic disease states. Currently it is based on whether the patient has had treatment with chemotherapy. I’m sure there are much more rational alternatives to this framework.