Other prostate cancer news: Wednesday, December 8, 2010

Other prostate cancer news out today includes:

  • An article in the Wall Street Journal about the financial motives behind intensity-modulated radiation therapy (IMRT)
  • Approval from the FDA for a Phase III pivotal trial of PROSTVAC-VF

An “exposé” in today’s Wall Street Journal looks into the motivations behind investments in IMRT equipment by some urology practices. The article does rather more than suggest that some practices have invested heavily in IMRT as a means to recoup money they used to be able to make by prescribing androgen deprivation therapy. Medicare reimburses physicians at a rate of approximately $40,000 for each patient treated with IMRT. The appropriateness of “self-referrals” by physicians to testing, imaging, and treatment centers in which they have a financial interest has long been a problematic matter, and it certainly isn’t exclusive to the urology community.

A story on Bloomberg Businessweek states that Bavarian Nordic has received approval from the  U.S. Food & Drug Administration (FDA) to initiate a pivotal, randomized, Phase III clinical trial of its investigational vaccine PROSTVAC-VF under a special protocol assessment (an SPA). Additional information is also available in a media release from Barvarian Nordic. Such a trial could lead to approval of PROSTVAC-VF for the treatment of advanced forms of prostate cancer.

According to the media release, Barvarian Nordic plans a single multi-national, randomized, double-blind, placebo-controlled study with three study arms including about 1,200 patients. To be eligible to participate in the Phase III trial, patients must have metastatic, castration-resistant prostate cancer (mCRPC) but they must be chemotherapy-naïve. Patients in two study arms will receive either PROSTVAC-VF alone or PROSTVAC with adjuvant doses of granulocyte macrophage colony stimulating factor (GM-CSF).  Patients in the third study arm will receive a placebo. The primary study endpoint will be overall survival (OS), and for the trial to have a positive result either one or both of the active treatments must offer signifciantly better OS than the placebo.

When given in combination with GM-CSF in an earlier, randomized Phase II clinical trial, PROSTVAC-VF demonstrated an 8.5-month overall survival benefit compared to placebo.

As yet there is no information on the ClinicalTrials.gov web site (or in the company’s media release) about the actual study sites or when the trial might, in fact, start to enroll patients.

One Response

  1. I know it is not “fashionable” to quote Ralph Moss, who is considered a “conspiracy theorist” by many, but in his book The Cancer Industry, which I read many years ago, he had some revealing financial analyses of how to recoup the very high cost of MRI and CAT scanning equipment:

    Form a group, buy the equipment and make sure that all your patients and your partners’ patients are referred to the group facilities.

    Machinery paid off in 12 months: clear profit thereafter. Quite simple really.

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