Finasteride reduced risk for prostate cancer and did not increase the risk for prostate cancer death, according to a presenter at the Annual American Urological Association Meeting in San Francisco.
Previously, the Prostate Cancer Prevention Trial showed finasteride increased the number of high-grade prostate cancers, even as it reduced patients’ overall risk for prostate cancer by 25%. The FDA added a black box warning to the drug as a result.
“What we can now say is that finasteride not only significantly reduces a man’s risk [for] prostate cancer, it is safe to use based on very long-term follow-up in our study,” Ian Thompson, MD, president of CHRISTUS Santa Rosa Hospital Medical Center in San Antonio, Texas, said in a press release. “In [the Prostate Cancer Prevention Trial], we found no increased risk [for] prostate cancer death [among] men who took finasteride compared with men who did not. These results are transformational. Prostate cancer is the most common cancer diagnosed in American men, and we have found an inexpensive, effective drug that can prevent it. I’m pleased to report that we’ve answered the questions and closed the book.”
In the Prostate Cancer Prevention Trial, researchers randomly assigned 18,882 men to receive finasteride or placebo from 1993 to 1997. The intervention ended in 2003.
Thompson and colleagues matched participants from the Prostate Cancer Prevention Trial with records from the National Death Index — a CDC-run database of death records — reviewing approximately 300,000 person-years of data over a median follow-up of 18.4 years.
Among participants in the trial, 42 died of prostate cancer in the finasteride group compared with 56 deaths in the placebo group.
“This discovery could benefit tens of thousands of men each year in the United States by identifying a drug that can safely and effectively prevent prostate cancer,” Thompson said.
Thompson added that prostate cancer treatment can have such side effects as urinary incontinence and erectile dysfunction.
“My hope is that the visionary decision of our NCI colleagues to conduct this study, and the scientific evidence it produced these last 25 years, will provide a lasting benefit for patients,” Thompson said. – by Andy Polhamus
Thompson I. Presented at: American Urological Association Annual Meeting; May 18-21, 2018; San Francisco.
Disclosures: Thompson reports no relevant financial disclosures.