Barvarian Nordic starts multi-center, Phase III trial of Prostvac

Barvarian Nordic has initiated the expected, randomized, multi-center Phase III trial of Prostvac® in men with asymptomatic and minimally symptomatic, metastatic, castration-resistant prostate cancer (mCRPC).

The full corporate media release about this trial is available on line. The trial is actually being carried out by BN ImmunoTherapeutics  — a wholly owned division of Barvarian Nordic. Prostvac is a subcutaneously administered  therapeutic “vaccine” that stimulates an immune response to prostate cancer cells.

This pivotal Phase III trial is expected to enroll about 1,200 patients in three study arms over the next 2 years at 300 study centers in 20 different countries. Eligible patients must have evident, metastatic prostate cancer and a rising PSA after prior hormonal therapy. The primary endpoint for the study will be overall survival. The summary protocol for the trial is available on the web site.

Results of this trial are not expected until at least mid 2015. The three arms of the trial will include:

  • Prostvac V/F + TRICOM + GM-CSF
  • Prostvac V/F + TRICOM + GM-SCF placebo
  • Prostvac V/F placebo + GM-CSF placebo

As previously reported, a small, randomized, Phase II trial showed a 44 percent reduction in mortality rate with an 8.5-month improvement in median overall survival compared to a placebo. Repetition of a result of this magnitude in a large, three-arm trial would be highly significant.

6 Responses

  1. Prostvac V/F has TRICOM in it (i.e., both active vaccine treatment arms have TRICOM).

    Trial is testing: Prostvac V/F + GM-CSF vs. Prostvac V/F + GM-CSF placebo vs Prostvac V/F placebo + GM-CSF placebo.

  2. Dear Dr. Godfrey:

    Thank you for this clarification. You may wish to note that that is not clearly evident in the initial table in the information about the trial on the web site. It is, however, evident in the main, three-part table.

  3. I am a medical doctor, a pulmonologist, living and working in Brazil. I was diagnosed with prostate cancer 4 years ago, without an opportunity for prostatectomy. I did hormonal therapy but it is not effective at this moment and I began with Docetaxel. I have bone metastases but I am working normally. I will visit USA on January 19. As a medical doctor I have a scientific and open mind. I would like to enroll in this trial of Prostvac. Please contact me.

  4. Dear Dr. Perez:

    If you click here you will be able to find a complete list of all of the centers that are enrolling patients into the Prostvac Phase III trial, with e-mail addresses and telephone numbers for contact information. Prostate Cancer International and The “New” Prostate Cancer InfoLink have no direct involvement in the conduct of this trial.

  5. I wonder if “vaccines” such as Prostvac or Provenge could be used in men with early stage, low- to mid- grade prostate cancer, as a non-invasive alternative to other forms of therapy (with a goal to decrease tumor size or preventing it from spreading). I don’t think such approach is being tested now and I’m not even sure if there are grounds to believe such approach might work. But it would be great if there was a vaccine-based therapy to address early cancer, that wouldn’t have the side effects of standard invasive therapies and wouldn’t carry the risk of the cancer spreading (or would minimize it) that active surveillance carries.

  6. Pawel:

    There are actually very good reasons to believe that such an approach is at least feasible in men with clinically significant, low- and intermediate-risk prostate cancer. The problem is going to be proving that it is effective because appropriate studies are likely to take years to mature.

    Having said that, I do think that we will see such trials within the next decade. They will need to be carried out with very careful patient enrollment and stratification criteria if they are to show us who will benefit. It would of course help if we were able to find some marker (other than PSA levels) for progression of prostate cancer in patients being so treated.

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