Abstract
The Prostate Cancer Prevention Trial (PCPT) demonstrated that finasteride therapy significantly reduced the risk of prostate cancer by 24.8% ( p < 0.001) compared with placebo. Controversially, there was an increased incidence of high-grade (Gleason score ≥ 7) tumours in the finasteride arm compared with placebo. The increase in incidence of high-grade disease observed in finasteride-treated subjects does not appear to be a histopathologic effect. A number of potential biases have been identified, including increased detection rate due to prostate volume reduction and improved prostate-specific antigen specificity and sensitivity for detecting prostate cancer. This would suggest that there was an improved detection of overall prostate cancer as well as high-grade prostate cancer in men treated with finasteride, rather than an increase in risk compared with placebo. Further analyses of the data from the PCPT together with other clinical findings strongly suggest that the increase in high-grade tumours in the finasteride arm is an artefact.
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