AUA and ASCO to “archive” clinical guidance of use of 5-ARIs for prostate cancer prevention

According to a message to its members issued today by the American Urological Association (AUA), the AUA and the American Society of Clinical Oncology (ASCO) are archiving their collaborative 2008 guideline entitled Use of 5-alpha Reductase Inhibitors for Prostate Cancer Chemoprevention.

This guideline has now been removed from the “Clinical Guidance” section of the AUA’s website, but is still available in the “Archived Guidelines” section. According to the message sent to the AUA members, “This decision is in response to the U.S. Food and Drug Administration’s denial of the supplemental New Drug Application for dutasteride for prostate cancer chemoprevention” — a denial issued by the FDA in late January 2011.

The AUA further recommends to its members that using 5-alpha reductase inhibitors (5-ARIs) like dutasteride and finasteride for prostate cancer prevention “is not FDA-approved and should be performed with caution.” The message concludes by noting that 5-ARIs “maintain an FDA-approved indication to treat symptomatic benign prostatic hyperplasia.”

The “New” Prostate Cancer InfoLink believes that some urologists and urologist oncologists will continue to prescribe 5-ARIs for the prevention of clinically significant prostate cancer in carefully selected individuals who are at potentially high risk for prostate cancer, despite the fact that the FDA denied a formal approval of dutasteride for use in this indication. The “archiving” of the joint ASCO/AUA guidance document is probably (as much as anything else) a way for the two organizations to protect themselves legally from possible future accusations that they continue to “recommend” the use of 5-ARIs for chemoprevention of prostate cancer. We do, after all, live in a highly litigious society.

The evidence regarding the actual effect of 5-ARIs in the prevention of prostate cancer and the risk that this use of ARIs may actually increase risk for high-grade prostate cancer is still debatable and controversial, with strong opinions on either side of the issue.

4 Responses

  1. Why deprive some poor guy the joys of prostate cancer treatment when he can be denied access to efficacious prevention and need treatment for the rest of his life to manage incontinence, impotence, and the depression caused by both! A patient for life and a big ol’ “X” in the “cure” column vs. the tedium of writing a boring Rx (heck, even some uppity promary care physician might attempt to do that) and having to explain (admit) that some of what we currently call “cancer” goes away when it exposed to a low side-effect drug, so low in side effects that it’s actually used for cosmetic purposes.

    The FDA’s decision is a brutal, unethical crime.

  2. My rebuttal (to the FDA’s decision) can be reviewed here, and I will edit that paper to make note of the AUA and ASCO”s archiving that is obviously a case of “CYA.”

  3. Dear Tracy:

    I feel obliged to point out that the FDA’s decision in no way stops any physician from prescribing dutasteride as a means to prevent prostate cancer in appropriately selected patients … although it does have to be said that the data supported widespread use of dutasteride for prevention was always less than 100% compelling.

  4. I have been on Avodart for over 6 years. I firmly believe it has slowed the growth of my cancer and saved me from radical treatment.

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