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

Redman, MW and Tangen, CM and Goodman, PJ and Lucia, MS and Coltman, CA Jr and Thompson, IM (2008) Finasteride does not increase the risk of high-grade prostate cancer: a bias-adjusted modeling approach. Cancer prevention research, 1 (3). pp. 174-181. ISSN 1940-6207

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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.

Item Type: Article or Abstract
Additional Information: This article is freely available at the journal website.
DOI: 10.1158/1940-6207.CAPR-08-0092
PubMed ID: 19138953
PMCID: PMC2844801
Grant Numbers: U10 CA037429
Keywords or MeSH Headings: * Aged * Bias (Epidemiology) * Biological Markers/analysis * Biopsy * Finasteride/therapeutic use* * Follow-Up Studies * Humans * Male * Middle Aged * Models, Statistical* * Neoplasm Staging * Odds Ratio * Placebos * Prevalence * Prostatectomy * Prostatic Neoplasms/epidemiology* * Prostatic Neoplasms/pathology* * Prostatic Neoplasms/prevention & control* * Prostatic Neoplasms/surgery * Risk
Subjects: Health Care > Risk and Preventive Health Services > Preventive drugs
Research Methodologies > Epidemiology > Risk assessment
Diseases > Solid tumors > Prostate cancer
Depositing User: Library Staff
Date Deposited: 04 Mar 2010 23:11
Last Modified: 14 Feb 2012 14:43

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