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Prevention with Finasteride

Prevention with Finasteride. Ian M. Thompson, MD October, 2009. The Prostate Cancer Prevention Trial. Enrollment. Randomization. Finasteride. Placebo. F/U q3mo x 7yr Annual DRE & PSA Biopsy for cause. End of Study Biopsy. End of Study Biopsy. PSA Index. X%. Placebo. X%. Finasteride.

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Prevention with Finasteride

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  1. Prevention with Finasteride Ian M. Thompson, MD October, 2009

  2. The Prostate Cancer Prevention Trial Enrollment Randomization Finasteride Placebo F/U q3mo x 7yrAnnual DRE & PSA Biopsy for cause End of Study Biopsy End of Study Biopsy

  3. PSA Index X% Placebo X% Finasteride PSA (ng/ml) 0 z 4.0 Finasteride Placebo Index Index

  4. Total Number of Cancers by Gleason Score 25% Risk Reduction Thompson et al, NEJM 349:215, 2003

  5. Concerns Regarding PCPT

  6. It now appears that increased sensitivity of detection may have led to increase in HG tumors Finasteride: Increases ability of PSA to detect cancer and aggressive cancer. Increases ability of DRE to detect cancer Improves ability of prostate biopsy to detect cancer and to detect aggressive cancer.

  7. Finasteride Placebo AUC finasteride = 0.757 AUC placebo = 0.681 p<.001 Thompson JNCI 2006;98:1128

  8. Finasteride Placebo AUC finasteride = 0.886 AUC placebo = 0.824 Thompson JNCI 2006;98:1128

  9. Finasteride improves sensitivity of PSA Journal of the National Cancer Institute, 2006;98

  10. Sensitivity FinasteridePlacebop-value Outcome Prostate CA 21.3% 16.7% 0.013 Gleason > 7 26.1% 21.7% 0.25 Gleason > 8 38.3% 36.4% 0.86 Finasteride improves sensitivity of DRE No decrease in specificity with finasteride. Journal of Urology 2007;177:1749-52.

  11. Impact of smaller prostate on sensitivity of biopsy for HG disease 70% 50% p = .01

  12. Redman Modeling of Actual Cancer rates Cancer RR=0.70 (0.64, 0.76) p < .0001 Gleason ≤ 6 RR=0.68 (0.57, 0.82) p < .0001 Gleason ≥ 7 RR=0.72 (0.55, 0.94) p < .02 8.2% 6.0% 12.9% 8.7%

  13. Conclusions • Finasteride significantly reduces risk of cancer. • High grade cancer detection may be increased through improved biomarkers and biopsy. (could be additional benefit) • Relative risk reduction - > 25% • Absolute risk reduction – depends on definition. As great as 7%, as low as 2%.

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