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 (2/22/11): 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.

In December, 2010, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted against recommending dutasteride(Avodart, GlaxoSmithKline) for the indication to reduce prostate cancer risk because in the view of the ODAC members, the risk for more aggressive tumors outweighed the potential for chemoprevention. ODAC recommended against prostate cancer chemoprevention labeling for the 5-alpha reductase inhibitors - dutasteride (vote 14 (no) to 2 (yes), with 2 abstentions) and finasteride (vote 17 (no) to 0 (yes), with 1 abstention).

As part of ASCO's scheduled updates to its guidelines, an ASCO-AUA Update Panel for the Clinical Practice Guideline published in 2008, "Use of 5-alpha Reductase Inhibitors for Prostate Cancer Chemoprevention" will convene shortly and will consider all the evidence bearing on the question of 5-ARIs for chemoprevention of prostate cancer, including the data and discussions that occurred at the ODAC meeting


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.


ASCO’s practice guidelines reflect expert consensus based on clinical evidence and literature available at the time they are written and are intended to assist physicians in clinical decision-making and identify questions and settings for further research. Due to the rapid flow of scientific information in oncology, new evidence may have emerged since the time a guideline was submitted for publication. Guidelines are not continually updated and may not reflect the most recent evidence. Guidelines address only the topics specifically identified in the guideline and are not applicable to interventions, diseases or stages of disease not specifically identified. Guidelines cannot account for individual variation among patients and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It is the responsibility of the treating physician or other health care provider, relying on independent experience and knowledge of the patient, to determine the best course of treatment for the patient. Accordingly, adherence to any guideline is voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances and preferences. ASCO guidelines describe the use of procedures and therapies in clinical practice and cannot be assumed to apply to the use of these interventions in the context of clinical trials. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of ASCO's guidelines, or for any errors or omissions.

Last Updated: 2/22/11