• Article

Economic analysis Randomized, placebo-controlled clinical trial of dutasteride in men at high risk for prostate cancer

Prostate cancer (PCa) is one of the most common cancers in American men and the second leading cause of cancer death [1]. An estimated 1 in 6 men will be diagnosed with PCa during their lifetime, and 1 in 36 men will die of PCa [1]. Medical expenditures for PCa were estimated to be $11.85 billion in 2010 and projected to reach $16.34 billion in 2020 (in 2010 dollars) [2].

Given this burden, medication to reduce the risk of PCa could provide economic and quality-of-life benefits. In recent years, the use of 5-alpha reductase inhibitors (5ARIs) has been studied for PCa risk reduction. Specifically, finasteride has been shown to reduce the incidence of PCa by 24.8% (95% confidence interval [CI]: 18.6%-30.6%; P < 0.001) in men with serum prostate-specific antigen (PSA) < 3.0 ng/ mL in the Prostate Cancer Prevention Trial [3]. In a recent clinical trial, the Reduction by Dutasteride of Prostatic Cancer Events (REDUCE), dutasteride (0.5 mg/day) was shown to reduce the risk of PCa by 22.8% (95% CI: 15.2%-29.8%; P < 0.001) compared with placebo in men with a negative biopsy and PSA > 2.5 ng/mL at baseline [4].

Previous analyses have examined the potential cost-effectiveness of a chemoprevention agent for prostate cancer. Because of incomplete information at the time, these analyses used decision analytic techniques, such as Markov models, to compile data from multiple sources and extrapolate the potential impact on costs and outcomes that might be seen over a man’s remaining lifetime [5-11]. Within the REDUCE study, data on resource use were collected along side of the clinical data. This study was an economic analysis of resource use data from the REDUCE clinical trial, comparing dutasteride with placebo in men at increased risk for PCa in the first 4 years of drug administration.


Chirila, C., Earnshaw, S., Black, L., McDade, C., Roskell, N., Shannon, P., ... Andriole, GL. (2011). Economic analysis: Randomized, placebo-controlled clinical trial of dutasteride in men at high risk for prostate cancer. Journal of Cancer Science & Therapy, S3, [004]. https://doi.org/10.4172/1948-5956.S3-004

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