Prostvac

Following up on Tall Allen's recent posting that began
"NCI just announced a new clinical trial for men on Active Surveillance. They give half the men a very promising new immunotherapy - Prostvac (the other half get a placebo). Prostvac is a modified virus vaccine that is attached to PSA and an immune booster, so it trains the immune system to seek out and destroy other cells that present PSA. The hope is that it will cause an immune attack against prostate cancer cells in the prostates of men on AS, thus allowing them to stay on AS longer."

On a previous Prostvac trial that recently closed, I was told by a nurse, when I called to enquire about eligibility, that the preliminary results were looking fantastic.

I have written to the maker, Bavarian-Nordic, inquiring about availability, in the world, for those in between the above-referenced trial (basically pre-treatment) and other trials (those CR), but maybe someone on this forum knows of some way to obtain this promising treatment for those not yet on ADT?

@Jerry L
Thanks, but with a name like Bavarian-Nordic one would think there should be a good chance of something being done in Europe--probably not approved there yet either, but who knows.
As Tall Allen said, there is a new trial coming, but it is not enrolling until March 2015, and then only for those pre-primary treatment.

As a comment about the original post, any nurse (?) who made a comment about the trial results "were fantastic" must have been talking about an early trial with no comparator. In other words no way to know if there was a real result or just statistical variation or placebo or an unknown action. Or mouse models or lab tests on cell lines and not humans. Or he/she had no idea what he/she was talking about.
I truly hope this is a breakthrough and since Prostvac is an off the shelf treatment without the lab mumbo-jumbo of Provenge it should be less expensive than Provenge. Which would be a double win.
The Phase III trial has a date for completion of data collection in December 2015, and with superb results could be earlier. This is a very short timeline in the scheme of clinical trials.

Question about Prostvac ---

If Prostvac ends up being approved, would it be also be administered to metastatic advanced prostate cancer patients, I wonder ?

Thanks for any knowledge on this,

Cyclone

The nurse was right. Phase II trials looked very good - 63% of men with CRPC (w/o mets) were progression free at 6 months. An earlier Phase II trial established its efficacy with mCRPC, demonstrating an 8.5 month increase in overall survival. In a Phase 1 trial of a combo of Prostvac, Yervoy & Leukine in men with mCRPC demonstrated that a quarter of the chemo-naive men had a decline in PSA of over 50%.

Cigafred, It hasn't been approved in Europe or anywhere else yet. Europe often, not always, waits for FDA approval. For liability reasons, it's unlikely that Bavarian Nordic would give you Prostvac, but if you can convince them, more power to you. Here's a link with the steps the FDA requires: Obtaining Investigational Drugs for Patients

Jerry L. - There's one at NIH combining Prostvac and Xtandi in non-metastatic hormone-sensitive men.

Cyclone - My guess is that it will be first approved for minimally symptomatic men with mCRPC because that has the earliest Phase III completion date. It is no longer recruiting, winmui.

There are lots of other immunotherapies in clinical trials. As I've said before, I think combo immunotherapy is the way to go (coupled with RT if possible), and the new PD-1 and PD-L1 blockers are smoking!

- Allen

Post Edited (Tall Allen) : 12/31/2014 9:29:47 PM (GMT-7)

Thank you Allen. I had seen the trial for which you provided a link, but went on when I read
"Key Eligibility:
•Men at least 18 years of age who have advanced castration-resistant prostate cancer."
But that may be a misprint, since under the detailed eligibility requirements I do not see any mention of castrate resistance, and the title says "Castration Sensitive". Or maybe I am once again abysmally unknowing about these technicalities.
I have e-mailed them for clarification

Yes, Allen is correct, in response to my e-mail the trial linked to above has responded:
I apologize for the incorrect web page.
The study is enrolling castration sensitive prostate cancer only.
(response came the evening of Jan. 1!)