Questions about Provenge

Hello,
I know many of you have been approved for Provenge. I'm considering it for my husband who is pT3bN1Mo. G9 Currently on HT waiting for aRT.

1. Is Provenge presently approved only for M1?
2. Is it possible to get Provenge if you pay out of pocket?
3. Any Canadians ever get Provenge? It is apparently not approved yet in Canada. I'm guessing that might be due to resources.

I looked at archived posts here and a couple of members who had early Provenge seems to be doing especially well.

Thank you.

In the US, it is only FDA-approved for metastatic castration-resistant prostate cancer. Both conditions must be met. I know of one man who got it for N1 M0. The cost for a set of 3 treatments is $93,000, and it adds a median of 4 months of life. It often has little effect on PSA, so the patient doesn't really know if it was effective - one has to just trust it worked.

The ProstVac trial at NIH excludes men with a positive bone scan or CT, and PSA must be over 0.8 after prostatectomy.

Thanks for your responses everyone. As TA mentioned, Provenge is extremely expensive but as Thomasjohn says, it provides hope. At a minimum, maybe there is a psychological benefit because the success of the treatment is not clear. One can hope.

Tn.Lee I'm sorry that you've recently been diagnosed with mets but great to get Provenge early.

The 4 month figure of prolonged survival is based on men with a predicted life span of 20 months. (ie toward end stage) according the the article in NEJM http://www.nejm.org/doi/full/10.1056/NEJMoa1001294#t=article


Is anyone aware of research that reports better outcomes if Provenge is given to men newly diagnosed with mets?

In an analysis of the IMPACT trial among men with metastatic castration-resistant PC, Provenge increased survival more than placebo among those who started treatment with lower PSA.

www.goldjournal.net/article/S0090-4295(13)00225-2/abstract

That led some to hypothesize that it might work better in men who are still hormone sensitive or who are not yet detectably metastatic.

The PROTECT trial evaluated Provenge among hormone-sensitive men. It did not meet its endpoint of significantly prolonging the time to biochemical failure, but they noticed that the PSADT slowed - whether that would have an impact on survival has not been determined.

clincancerres.aacrjournals.org/content/17/13/4558.long

The STAND trial among recurrent, non-metastatic hormone sensitive men, found that Provenge before ADT elicited a good immune response. But whether that will translate into improved survival is an open question

meetinglibrary.asco.org/content/146437-156

Most of the current trials involving Provenge are looking at combining it with other immunotherapies (checkpoint inhibitors), or with radiation or chemo to enhance the abscopal effect.

Other immunological agents (eg Prostvac, Keytruda) are getting a lot of attention, and are in trials now.

Annie said...
From all that I've read, it stands to reason that it's best to battle the beast early, when the burden is low and before it mutates.

Unfortunately, cancer is not reasonable. Some therapies don't do a thing until the cancer has mutated into a form that is susceptible to that therapy. For example, we just learned that docetaxel does nothing until after significant metastatic progression has occurred. Provenge also did not seem to do much for non-metastatic, hormone sensitive men. The timing and sequencing can make the difference between a therapy working or being a waste of money.

Mutation has already occurred, or his PSA would be undetectable under androgen deprivation,and would not be rising.

If you want to pay for something experimental, you might consider local treatment of the prostate (RP or RT). A recent clinical trial showed more benefit among men whose cancer is less progressed. If money is not an impediment, there are several therapies that are more promising than Provenge that would be available off label.