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February 22, 2007

Effect Of 1 Mg/day Finasteride On Concentrations Of Serum Prostate-Specific Antigen In Men With Androgenic Alopecia: A Randomized Controlled Trial

UroToday.com- Daily finasteride therapy at the prescribed dose for benign prostatic hyperplasia (5 mg) is known to result in a decrease in serum PSA by 50 percent. The impact of finasteride on serum PSA at the lower dose (1 mg/day) prescribed for male-pattern hair loss is unknown.

In the January issue of Lancet Oncology, D'Amico and Roehrborn report on a placebo-controlled, double-blind, prospective study designed to evaluate this issue. Over a period of 2 years, 355 men with a history of hair loss ages 40 to 60 years were randomized to finasteride (1 mg/day) or placebo on a 4:1 ratio. The main objective of the study was to evaluate differences in serum PSA after 48 weeks of therapy.

At completion of the study, 1mg/day finasteride resulted in a median serum PSA decrease of 40% (95% CI 34 to 46) in men ages 40-49 years (mean PSA 0.8 ng/ml) and 50% in men ages 50 to 60 years (mean PSA 1.1 ng/ml). These were statistically significantly different from decreases in PSA in men taking placebo for both age groups [0% (mean PSA 1.0 ng/ml) and +13% (mean PSA 1.2 ng/ml) respectively].

This well-conducted study supported by Merck conclusively supports adjusting the serum PSA concentration (x2) in patients receiving Propecia therapy for male-pattern baldness. The fact that 1 mg of finasteride resulted in the same PSA reduction as the 5 mg dose raises important questions and concerns. What happens to serum PSA in men taking Propecia after 48 weeks? Are patients taking Propecia at an increased risk for high-grade prostate cancer? Should patients with an extensive family history of prostate cancer avoid Propecia?

D'Amico A, Roehrborn, CG
Lancet Oncol. 2007 Jan; 8(1):21-5

Reviewed by UroToday.com Ricardo F. SГЎnchez-Ortiz, MD

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