Finasteride saves men from prostate cancer, doesn’t increase risk of death

SAN ANTONIO (August 15, 2013) – A long-term follow-up to a groundbreaking study led by the director of the Cancer Therapy & Research Center confirms that a drug shown to reduce risk of prostate cancer by more than a third has no impact on lifespan but further reduces the risk of prostate cancer.

Reducing the risk of prostate tumors by about 30 percent – and low-grade tumors by 43 percent – means thousands of men can avoid a cancer diagnosis and subsequent treatments that significantly affect quality of life, said Ian M. Thompson Jr., M.D., director of the CTRC at The University of Texas Health Science Center at San Antonio.

The study was published today in the New England Journal of Medicine.

“If you look at the number of prostate cancers that are diagnosed annually and multiply that by 30 percent, that’s the number of cancers we might be able to prevent each year,” Dr. Thompson said.

“That’s more than 71,000 men. That’s more than 175 jumbo jets full of men who won’t get cancer, who won’t face treatments with side effects like sexual dysfunction.”

“There’s nothing like disease prevention. Nothing comes close.”

Finasteride is a generic drug developed and currently used by physicians to treat enlarged prostate and male pattern baldness. While it significantly reduces the risk of prostate cancer, during the trial of 19,000 men a slightly higher percentage of those on finasteride developed high-grade cancer than those taking a placebo (although this difference shrank in the follow-up analysis).

This caused concern and debate in the medical community, and doctors backed away from prescribing the drug. Multiple studies prompted by this concern ultimately concluded finasteride, by shrinking the prostate and making the PSA test work better, made the tumors easier to find. Nonetheless, in 2011, the Food and Drug Administration added a warning to the label about the increased risk of being diagnosed with high-grade prostate cancer.

The Prostate Cancer Prevention Trial, funded by a National Cancer Institute grant, began in 1993. It was coordinated by SWOG, an international network of research institutions, and led by Dr. Thompson. The men in the finasteride arm had a median age of 62 and took the drug for seven years.

The 18-year follow-up to the study examined survival in both study arms to see if there was an increased risk of death in men who took finasteride. The results show no impact on either overall survival or survival after prostate cancer diagnosis.

“What that tells us is that in men who take finasteride, a third fewer will be diagnosed with prostate cancer.” Dr. Thompson said. In today’s medical climate, many men with even low-grade tumors are treated unnecessarily, he noted, and those treatments carry a considerable burden for the patient and for society.

“If we can free thousands of men each year from that unnecessary burden,” he said, “we could use those resources for other important medical interventions, reducing death and suffering from disease.”

The Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at San Antonio is one of the elite academic cancer centers in the country to be named a National Cancer Institute (NCI) Designated Cancer Center, and is one of only four in Texas. A leader in developing new drugs to treat cancer, the CTRC Institute for Drug Development (IDD) conducts one of the largest oncology Phase I clinical drug programs in the world, and participates in development of cancer drugs approved by the U.S. Food & Drug Administration. For more information, visit

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