Use of 5-alpha Reductase Inhibitors for Prostate Cancer Chemoprevention: American Society of Clinical Oncology-American Urological Association 2008 Clinical Practice Guideline

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Use of 5-alpha Reductase Inhibitors for Prostate Cancer Chemoprevention: American Society of Clinical Oncology-American Urological Association 2008 Clinical Practice Guideline

Published in Journal of Clinical Oncology, Vol 27, No 9 (March 20), 2009: pp. 1502-1516

Barnett S. Kramer, Karen L. Hagerty, Stewart Justman, Mark R. Somerfield, Peter C. Albertsen, William J. Blot, H. Ballentine Carter, Joseph P. Costantino, Jonathan I. Epstein, Paul A. Godley, Russell P. Harris, Timothy J. Wilt, Janet Wittes, Robin Zon, and Paul Schellhammer

Special Announcement (Update 3/15/12): On January 26, 2011 FDA issued a Complete Response letter for the supplemental New Drug Application for dutasteride for prostate cancer chemoprevention. A Complete Response letter is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and it cannot be approved in its present form. The notification refers only to the supplemental file regarding an indication to reduce prostate cancer risk and not the existing FDA-approved uses. Dutasteride is currently approved to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

The ASCO-AUA Update Panel for the guideline “Use of 5-alpha Reductase Inhibitors for Prostate Cancer Chemoprevention: American Society of Clinical Oncology-American Urological Association 2008 Clinical Practice Guideline,” in consultation with the ASCO Clinical Practice Guideline Committee, is considering when to update this Guideline, if at all.

In 2011, the FDA notified healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs [finasteride and dutasteride] has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).

Purpose: To develop an evidence-based guideline on the use of 5-alpha reductase inhibitors (5-ARIs) for prostate cancer chemoprevention.

Methods: The American Society of Clinical Oncology (ASCO) Health Services Committee (HSC), ASCO Cancer Prevention Committee, and the American Urological Association Practice Guidelines Committee jointly convened a Panel of experts, who used the results from a systematic review of the literature to develop evidence-based recommendations on the use of 5-ARIs for prostate cancer chemoprevention.

Results: The systematic review completed for this guideline identified 15 randomized clinical trials that met the inclusion criteria, nine of which reported prostate cancer period prevalence.

Conclusion: Asymptomatic men with a prostate-specific antigen (PSA) 3.0 ng/mL who are regularly screened with PSA or are anticipating undergoing annual PSA screening for early detection of prostate cancer may benefit from a discussion of both the benefits of 5-ARIs for 7 years for the prevention of prostate cancer and the potential risks (including the possibility of high-grade prostate cancer). Men who are taking 5-ARIs for benign conditions such as lower urinary tract [obstructive] symptoms (LUTS) may benefit from a similar discussion, understanding that the improvement of LUTS relief should be weighed with the potential risks of high-grade prostate cancer from 5-ARIs (although the majority of the Panel members judged the latter risk to be unlikely). A reduction of approximately 50% in PSA by 12 months is expected in men taking a 5-ARI; however, because these changes in PSA may vary across men, and within individual men over time, the Panel cannot recommend a specific cut point to trigger a biopsy for men taking a 5-ARI. No specific cut point or change in PSA has been prospectively validated in men taking a 5-ARI.

The practice guideline is not intended to substitute for the independent professional judgment of the treating physician. Practice guidelines do not account for individual variation among patients and may not reflect the most recent evidence. The guideline does not recommend any particular product or course of medical treatment. Use of the practice guideline and summary is voluntary.

Last Updated: 3/15/12