Finasteride: No Survival Benefit

Gerald Chodak, MD


March 12, 2013

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Hello. I am Dr. Gerald Chodak for Medscape. At the ASCO (American Society of Clinical Oncology) Genitourinary Cancers Symposium in February 2013, Goodman and colleagues presented a paper that summarized the long-term follow-up outcomes from the Prostate Cancer Prevention Trial.[1] The original study[2] was conducted from 1993 to 1997 and randomly assigned men to receive either 5 mg of finasteride or placebo, with the hope of reducing the odds of developing prostate cancer.

Indeed, that study did show a statistically significant reduction in detection, but it also found that those men who were diagnosed with prostate cancer were more likely to be diagnosed with higher-grade disease. The US Food and Drug Administration (FDA) has not granted an approval for this new indication as a result of that finding. The concern is that somehow it might have made some men worse off.

The follow-up[1] of this study, now with 15 years of information, shows no statistically significant difference in survival between the men who received finasteride and the men who received placebo. Among the men who were diagnosed with prostate cancer [and had received finasteride], there was also no significant difference in survival [compared with those in the placebo group]. A subset analysis showed that men who had low-risk prostate cancer and had received finasteride had a better survival. But whether or not that was related to the finasteride or different ways in which patients were managed is unclear.


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