Progress in chemopreventive agent development for prostate cancer is guided by identification of new molecular targets through high throughput functional genomic screens and empirical evidence derived from epidemiologic studies, experimental models, and unexpected results from randomized primary prevention trials. More than a dozen agent classes with potential for prostate cancer prevention are in clinical development, including natural products, with many more novel classes expected in the near future (epidermal growth factor receptor inhibitors, proteosome inhibitors, etc.). Suitable study cohorts for definitive prevention trials can be identified and represent potential therapeutic niches for new agent registrations. However, the failure to identify and validate noninvasive surrogate endpoints that predict cancer incidence reduction is a major rate-limiting step thwarting the design and conduct of efficient clinical prevention trials for prostate cancer and the active participation of the pharmaceutical industry.
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