Do 5-ARIs prevent prostate cancer in patients with benign prostatic hyperplasia (BPH)?

Updated: Feb 19, 2021
  • Author: Levi A Deters, MD; Chief Editor: Edward David Kim, MD, FACS  more...
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On June 9, 2011, the US Food and Drug Administration (FDA) announced revisions to the prescribing information for 5-ARIs. The FDA advised that prior to initiating therapy with 5-ARIs, clinicians should perform appropriate evaluations to rule out other urological conditions, including prostate cancer, that might mimic BPH.

The FDA's action was based on findings from 2 large, randomized, controlled trials of 5-ARIs for prostate cancer prevention, which reported that trial participants taking 5-ARIs had an increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer). Both trials—the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial—observed a decreased incidence of prostate cancer overall when preventive treatment included 5-ARIs, but an increased incidence of high-grade prostate cancer in men taking dutasteride or finasteride compared with placebo. [21, 22]

In contrast, a 2015 retrospective cohort study conducted in 13,892 men with a new diagnosis of prostate cancer found that use of 5-ARIs before prostate cancer diagnosis was not associated with an increased risk of prostate cancer-specific mortality (adjusted hazard ratio, [aHR] 0.86) or all-cause mortality (aHR, 0.87). The researchers cite the need for additional studies to replicate these findings. [23]

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