PREVAIL trial of MDV3100 now fully enrolled

According to information released today by Astellas Pharma and Medivation, the PREVAIL trial of MDV3100 (also now known as enzalutamide) in men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC) is fully enrolled.

The joint company media release states only that:

The randomized, double-blind, placebo-controlled, multi-national Phase 3 PREVAIL trial has enrolled 1,680 patients at sites in the United States, Canada, Europe, Australia, Asia and Israel. The trial enrolled patients with metastatic prostate cancer who progressed despite treatment with androgen deprivation therapy. The co-primary endpoints of the trial are overall survival and progression-free survival; secondary endpoints include time to first skeletal-related event and time to initiation of chemotherapy. The trial is designed to evaluate enzalutamide at a dose of 160 mg taken orally once daily plus standard of care versus placebo plus standard of care.

It also notes that study centers in some selected Asian areas will remain open “to gain additional information in these unique populations.”

There is no formal comment from the companies about when they might expect to have data based on overall survival allowing for breaking the blind on this study.

For the benefit of some readers, we note that the PREVAIL trial for enzaluamide is comparable to the so-called 302 study of abiraterone acetate from which data was just reported at the annual meeting of the American Society of Clinical Oncology (ASCO) in the past few days.

6 Responses

  1. Comparable, except Medivation enrolled 1,700 men compared to just over 1,000 for Cougar/Johnson & Johnson’s abiraterone/Zytiga. Medivation should have unequivocal results without issues of primary endpoint confounding.

  2. Within what time frame should we expect to see early results of the PREVAIL trial? The AFFIRM trial results were positive; I hope the PREVAIL results are even better.

  3. When will enzalutamide be released for treatment in the USA?

  4. Dear Geoff:

    It is impossible to make any really accurate guesstimate of when the results of the PREVAIL trial might be available because we don’t know whether the sponsors will decide they want to obtain the data from both co-primary endpoints of this trial (overall survival and progression-free survival) before they break the blind. I think that they will, but I can’t be sure. It would likely depend on how big the progression-free survival benefit is, and that endpoint will be the first to be reached.

    At the moment, my “best guess” is that we may know the results of PREVAIL some time in late 2013 or early 2014, but please don’t hold me to that because I really have no special insight. In fact, if the sponsors really do want this trial to achieve the overall survival endpoint, then the better enzalutamide works in these patients compared to the placebo, the longer it will take before we know the results (because it will take a longer time for enough men on the enzalutamide arem of the trial to die).

  5. Dear Mary:

    I think the manufacturers are hoping that the FDA will approve this drug in September or October this year. I am a little more conservative in my expectations, but I really do hope that it will occur before the end of the year. Of course it really depends on the quality of the new drug application submitted by Medivation, and I have no information about that.

  6. I will have been in this trial for a year on 29 September. Although I cannot be sure I am on it rather than Casodex, the results are great so I think so. PSA < 0.1 from 7 and bone lesions stable and reduced in one case. No really troubling side effects. I am 70, diagnosed in September 2010; Zoladex started to fail me after 6 months, as evidenced by a rising PSA.

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