Prostvac trial for non-metastatic, hormone sensitive, recurrent PC

There are so few trials for this situation, I thought I'd promote it. It's a trial of a potentially good immunotherapy, Prostvac VF, among men who have recurrent PC after previous treatment (either surgery, radiation or both) with no detected mets and who still respond to hormone therapy. This is much earlier in PC progression than most immunotherapy trials. I suspect earlier is better. The other nice thing is that there's no placebo - everyone gets the Prostvac VF - some after a 6 month wait.

The definitions they're using for biochemical recurrence is a rising PSA (confirmed on 3 tests) ≥ 0.8 ng/ml if you had surgery, or nadir+2.0 ng/ml if you had radiation only. They also want to see a PSADT between 5 and 15 months.

The trial is at NIH in Bethesda. They are usually very good about picking up all travel and accommodation costs. They're taking only 80 guys, so if you're interested, call soon! Here's the link with the contact info:

Prostvac in Patients With Biochemically Recurrent Prostate Cancer

- Allen

Thanks Allen.

I've been in contact with them for the last year. There are also going to be other trials at Bethesda in the near future that use Prostvac on both metastatic-castrate resistant and metastatic-castrate sensitive PC. (The metastatic-castrate sensitive trial will include a combination of ADT, Docetaxel, and Prostvac).

As soon as I have info on these, I will update this thread...that is, unless you have info on them.

Jerry

Allen,

Are you sure it's only for newly diagnosed? I see this:

- May have had up to 24 months of ADT (in the nonmetastatic setting) and are at least 12 months removed from treatment"

I'm curious. Does the fact that all of these multi-faceted, combination trials are going on with Prostvac mean that this is going to a big new drug? I don't think Phase III results on Prostvac by itself are due to come out until beginning of 2017. It sounds like researchers are pretty excited by it.

It was developed by NIH in partnership with Bavarian Nordic (and licensed to Bristol Myers Squibb), and they are doing the clinical trials, so there is a lot of government and private money behind it. Most of the time, drug companies are in a rush to re-coup their investment. They often test new drugs among the most progressed men (i.e., symptomatic, post-docetaxel, metastatic, castrate-resistant) because it will be quicker to get the survival data necessary to get FDA approval. Later, they may start testing for earlier indications that take longer to prove. Because it has significant resources behind it, Prostvac is being tested for multiple indications.

That said, there are a lot of different approaches to immunotherapy in clinical trials, including new drugs and combinations (like Prostvac+Yervoy). Unfortunately, prostate cancer seems to be especially good at evading destruction by the immune system.

Jerry L,

He also clarified that what he means by "newly diagnosed" in the docetaxel+Prostvac trial is newly diagnosed as metastatic. He said, "Patient may have had previous RT and surgery, but ultimately developed metastasis with normal testosterone while in follow-up. Or they may have presented with newly diagnosed disease that was metastatic at presentation." He didn't say how new "newly" has to be.

- Allen

Allen,

When this becomes available, do you think that Yervoy will be something that will be approved to be used in combination. That was the really impressive data.

NIH does a great job! I completed a two year trial this past August, which included prostvac and xtandi. Yes, all travel is covered full and $50 toward your choice of hotel. Each month I chose to fly (early) from central Illinois to Chicago and then on to Reagan where I would catch the Metra to NIH (30 MINUTES) I would arrive around noon ,give my blood and then head to the 12th floor for a short app. I could usually then catch the NIH 2:30 schuttle back to Reagan, but if things were running late they would call me a taxie and pay for it. Anyway , I would arrive back home around 10:00pm. They have have a great travel office at NIH that schedules all your flights.---had only one cancelled flight over the two year period. I have to say, it was an enjoyable two years.
Wampuscats
Jim and Marie

Allen:

What is the difference between Provenge and Prostvac?

What are the SE of Prostvac?

I wonder if an abdominal lymph node "met" is considered a "met."

Mel

Mel
Good question. Because it's abdominal rather than pelvic, they might consider that a distant met, even though it's staged N1 M0. Call them and ask.

Provenge and Prostvac represent different strategies for activating an immune response. With Provenge, they take your own immune cells (dendritic cells) that already have been exposed to the cancer, they engineer them to target PAP, clone them, and add another immune stimulant (GM-CSF), and then infuse the amped up cells back into you. With Prostvac, they engineer two different crippled (not capable of infection) viruses (fowlpox and vaccinia) with an added genetic component that targets PSA. They add 3 co-stimulatory molecules along with it to beef up the response.

I think the major risk is the same with both - a runaway, potentially fatal immune reaction.

- Allen

Allen,

I got the impression that it's for those guys that are hormone sensitive, measurable metastatic, and not on HT for more than 120 days....and there are other criteria.

So even for me who is on IHT that really became metastatic 5 years ago, they are considering me.

You miss 100% of the shots you don't take. So, if anyone is interested, I think these trials are a great opportunity to get an immunotherapy early. It can't hurt to ask.

And it's especially a good opportunity for the newly diagnosed with or without mets where you can combine the proven benefit of chemo+HT and Prostvac. If you have to go down the chemo road anyways because it's becoming standard of care in this setting (at least for high volume met guys) why not add the immunotherapy.

Jerry