UroToday - In the Prostate Cancer Prevention Trial (PCPT), men randomized to 7 years of finasteride 5mg daily demonstrated a 24.8% reduction in the incidence of prostate cancer (CaP) relative to men on placebo. However, there was an increased prevalence of Gleason score 7-10 in the finasteride group compared to placebo (6.4% vs. 5.1%). In the online edition of Urology, Dr. Kaplan and associate investigators report on an analysis of the PCPT data, adjusted for prostate volume.

Men on finasteride had a 24% reduction in the prostate volume (PV) but the same number of biopsy cores taken. This computed to a 27% increase in the mean prostate biopsy sampling density for finasteride patients compared to placebo. Adjusting for biopsy sampling density, Cohen had reported that the CaP risk reduction was actually 45% relative to placebo and there was a significant reduction in the risk of low-grade cancer with no significant effect on the risk of high-grade cancer. However, these reports did not allow for determination of the individual Gleason scores for which finasteride had a beneficial effect on CAP risk after adjustment for the biopsy sampling density. This study used a post hoc generalization of the pre-specified biopsy sampling density-adjusted analysis to examine the effect of finasteride on CaP risk relative to placebo at each individual Gleason score in the PCPT.

Among the 8,827 men who had biopsy sampling density measurements, 1,739 had CaP diagnosed - 1,031 in the placebo group and 708 in the finasteride group. The most frequently detected CAP was Gleason score 5, 6, and 7 cancer. The mean PV was 33.5cc in the placebo group and 25.2cc in the finasteride group. Finasteride significantly reduced the risk of CaP relative to placebo across Gleason score groups 4 to 7 with a 64% reduction on Gleason score 4, 58% reduction for Gleason score 5, 52% reduction for Gleason score 6 and 22% reduction in Gleason score 7. Finasteride had no effect on the individual Gleason score 8 through 10 prostate cancers. Finasteride led to a significant reduction in the probability of detecting CAP with a clear separation at year 2 that continued to increase through year 7.

Kaplan SA, Roehrborn CG, Meehan AG, Liu KS, Carides AD, Binkowitz BS, Heyden NL, Vaughan ED Jr
Urology. 2009 Mar 26. Epub ahead of print.

UroToday Contributing Editor Christopher P. Evans, MD, FACS

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