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Implications of the Prostate Cancer Prevention Trial: A Decision Analysis Model of Survival Outcomes

From the Department of Urology, University of Texas Southwestern Medical Center, Dallas; and Departments of Biostatistics and Applied Mathematics, and Clinical Cancer Prevention, University of Texas M.D. Anderson Cancer Center, Houston, TX

Address reprint requests to Yair Lotan, MD, Department of Urology, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390-9110; e-mail: Yair.Lotan{at}UTSouthwestern.edu

PURPOSE: To assess the estimated effect of finasteride prevention of prostate cancer on overall survival.

METHODS: Data for our decision tree model came from men in the two arms (finasteride or placebo) of the Prostate Cancer Prevention Trial (PCPT) and from clinically localized prostate cancer patients studied for long-term survival outcomes. Our model compared survival outcomes for men treated with finasteride or placebo. Prostate cancer rates were based on the 7-year period prevalence of prostate cancer detected in the PCPT; survival probabilities were abstracted from the long-term outcome studies. We assessed variability in the PCPT and long-term survival studies to test the variability of our model.

RESULTS: Survival advantages for a finasteride-treated (v those not treated with finasteride) population include gains of 1.7 months in 15-year cause-specific survival (assuming finasteride-altered Gleason scores and prostate cancer prevalence rates in the PCPT), of up to 3 months for cancers treated conservatively or surgically (assuming finasteride does not alter Gleason scores), and of 0.35 months (assuming the rate of cancers detected by for-cause biopsies in the PCPT), which increased to 1.7 months when assuming a 30% rate of biopsy-detected cancer in the PCPT placebo group. Model-variability analyses support several survival benefits associated with finasteride (eg, the uniform benefits assuming finasteride does not alter Gleason scores) but question certain others (eg, in 15-year recurrence-free survivals assuming finasteride does alter Gleason scores).

CONCLUSION: Finasteride can impart survival benefits according to our model, especially when we assume that finasteride does not alter Gleason scores.

Supported in part by grant No. CA16672 (University of Texas M.D. Anderson Cancer Center Support Grant) from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services.

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

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