It has just been announced that there are now two new additional sites added to the Early/Expanded Access Program for Enzalutamide (MDV3100). The program is technically a clinical trial designed to monitor MDV-3100’s safety in men with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.
This means that there are now a total of 16 states which have an Early/Expanded Acess Program and additional sites are still expected.
In this trial there are no placebos and no cost for the MDV3100/enzalutamide Please check with the trial site for any other costs which you might be required to pay.
Basic Eligibility Criteria:
CRPC/HRPC – on hormone therapy with progressive disease
3 weeks since Zytiga (abiraterone)
NO small cell or neuroendocrine features
Previously treated with Taxotere (docetaxel)
No brain metastases
HGB 9.0 or higher
No history of stroke or seizure
No significant cardiovascular disease
If you think you fit the above Criteria, contact one of the sites. below for further criteria and screening.
The two new sites are:
Stanford University Cancer Center
Contact: Denise Haas (650) 736-1252
Pal Alto, CA 94304
Tulsa Cancer Institute
Contact: Sharon Franklin (918) 292-8085
Tulsa, OK 74136
For a complete listing of all sites (other than the recently added sites described in this post) go to:
Joel T. Nowak, M.A., M.S.W.
What have you heard anout PSAs after Provenge. I have been told they go all over the map. I had Provenge Dec ’11 and my PSA has gone from 5 to 61.
How does one finally determine if Provenge is working or a failure?
There is no way of knowing if Provenge is going to extend our life (working). From a statistical point of view (group trend) it extends life , but from an individual perspective there is no way to know if you will receive the benefit, or if you do how much (some people will receive a survival benefit that far exceeds the statistically predicted benefit while others will not receive the benefit).
Most men will have their PSA number increase while receiving Provenge despite the fact that it does extend life. We have been trained to rely on our PSA numbers, but PSA is not a predictor for survival. Our goal should be to live longer (have a survival advantage) with a good quality of life. Provenge does not have a lasting negative impact on our quality of life and it may extend it.
As I have said in this blog, I will move immediately to Provenge the moment I become castrate resistant, while I still have a low PSA. It will not hurt me and it might help me.