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Randomized Controlled Trial
. 2008 Aug;1(3):174-81.
doi: 10.1158/1940-6207.CAPR-08-0092. Epub 2008 May 18.

Finasteride does not increase the risk of high-grade prostate cancer: a bias-adjusted modeling approach

Mary W Redman  1 , Catherine M Tangen, Phyllis J Goodman, M Scott Lucia, Charles A Coltman Jr, Ian M Thompson
Affiliations
Randomized Controlled Trial

Finasteride does not increase the risk of high-grade prostate cancer: a bias-adjusted modeling approach

Mary W Redman et al. Cancer Prev Res (Phila). 2008 Aug.

Abstract

Finasteride taken for 7 years in the Prostate Cancer Prevention Trial (PCPT) reduced the risk of prostate cancer by 25%, but with an apparent increased risk of high-grade disease. Subsequent analyses found that finasteride biases toward improved prostate cancer detection and accuracy in prostate cancer grading at biopsy. In our first analysis of the present study, we accounted for these biases in estimating the effect of finasteride on the risk of overall and high-grade prostate cancer. This analysis used PCPT data that included 3-month longer collection of endpoints than in the original report with observed prostate cancer rates of 22.9% (4.8% with high grade; placebo) versus 16.6% (5.8% with high grade; finasteride). Based on these updated results, the bias-adjusted prostate cancer rates are estimated to be 21.1% (4.2% high grade; placebo) and 14.7% (4.8% high grade; finasteride), a 30% risk reduction in prostate cancer [relative risk (RR), 0.70; 95% confidence interval (95% CI), 0.64-0.76; P < 0.0001] and a nonsignificant 14% increase in high-grade cancer (RR, 1.14; 95% CI, 0.96-1.35; P = 0.12) with finasteride. We then estimated rates of high-grade prostate cancer based on an analysis that incorporated grading information from radical prostatectomies in 500 subjects diagnosed with cancer. The resulting estimates were high-grade cancer rates of 8.2% (placebo) versus 6.0% (finasteride), a 27% risk reduction (RR, 0.73; 95% CI, 0.56-0.96; P = 0.02) with finasteride. Our third analysis examined the impact of biopsy sensitivity on the relative risk of high-grade prostate cancer and found that differential sensitivity of biopsy between the treatment arms can have a significant impact on risk ratio estimates. These collective results suggest that the observed, unadjusted higher risk of high-grade disease with finasteride seems to have been due to facilitated diagnosis resulting primarily from increased biopsy sensitivity with finasteride. Therefore, men undergoing regular prostate cancer screening or who express an interest in cancer prevention should be informed of the opportunity to take finasteride for preventing prostate cancer.

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Figures

Figure 1
Figure 1
Low and high grade cancer status by treatment arm by prostatectomy Estimated actual fractions of total subjects with low and high-grade cancer
Figure 2
Figure 2
Risk ratios for high grade prostate cancer under imperfect sensitivity of biopsy to detect high grade cancer with placebo and finasteride
Figure 3
Figure 3
Risk ratios for sensitivity to biopsy incorporating the prostatectomy data
See this image and copyright information in PMC

Comment in

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