USRF Research


Role of Finasteride (Proscar) Clarified by New Information

Leonard S. Marks, M.D.

Medical Director, USRF

March, 1998 -Finasteride (Proscar), the first FDA-approved medication for treatment of symptomatic BPH,was introduced in 1992 amidst much media fanfare. However, many physicians and patients have felt that the drug did not live up to its early promise, since many men failed to respond and in those that did, the response might not be seen for three - six months or longer.

Finasteride research has continued following release of the drug, and two recent articles indicate that the drug does indeed have a valuable role in the treatment of symptomatic BPH. That role was first clarified by Peter Boyle and associates, writing in the September, 1996 issue of Urology. These authors showed that a favorable response to finasteride was most likely to be seen in men with large prostate glands, especially in men with prostate volumes greater than 40 grams. Men with small prostates were less likely to gain symptomatic relief than men with large prostates.

A second publication, featured in the February 26, 1998 issue of the New England Journal of Medicine, demonstrated that finasteride reduced the need for surgery and the incidence of acute urinary retention. In a large (3040 men), randomized, placebo-controlled study, Dr. John McConnell and associates found that during four years of observation, placebo-treated men were more than twice as likely to require surgery or to experience acute urinary retention as finasteride-treated men. The study is known as the PLES (Proscar Long-term Efficacy and Safety ) study, and it is the first to show that any of the medications for symptomatic BPH can actually reduce the need for prostate surgery. The only side-effect of the drug, which was persistent and statistically significant, was a decrease in volume of ejaculate, seen beyond one year of treatment in 1.5% of men.

Key data from the PLESS study are shown in the following graphic:

We conclude that finasteride (Proscar) is an important treatment option for men with symptomatic BPH, who wish to reduce the symptoms and complications of this disorder, who have large prostate glands, who can wait several months for relief, and who can accept the small chance of an adverse sexual side-effect.

At USRF, we have been studying Proscar for more than 5 years.

1. Boyle, P., Gould, A.L., and Roehrborn, C.G. Prostate volume predicts outcome of treatment of benign prostatic hyperplasia with finasteride.
Urology 48: 398, 1996. Read the abstract.

2. McConnell,J.D., Bruskewitz, R., Walsh, P., et al. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia.
N.Engl.J.Med. 338: 557, 1998. Read the abstract.


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