Design considerations for efficient prostate cancer chemoprevention trials

J. Jack Lee, Ronald Lieberman, Jeff A. Sloan, Steven Piantadosi, Scott M. Lippman

    Research output: Contribution to journalArticle

    Abstract

    Prostate cancer, even with its substantial public health impact of 180,400 new cases and 31,900 deaths estimated for 2000, still has a very low annual incidence (0.27% for men 34.4 years and older), which makes designing and conducting efficient prostate cancer prevention trials a challenge. Definitive prevention trials with cancer endpoints, such as the Breast Cancer Prevention Trial (BCPT), Prostate Cancer Prevention Trial (PCPT), and Selenium and Vitamin E Cancer Prevention Trial (SELECT), require long trial duration (up to 12 years) and large sample size (up to 32,400 subjects) to accomplish their objectives. This article discusses design concepts for potential prostate cancer prevention trials that require fewer years, subjects, and resources to complete. Design elements, such as high-risk populations, randomization, surrogate endpoints, including quality-of-life endpoints, masking/blinding, and various clinical/statistical designs (including 1-way layout, all-versus-none, factorial, and adaptive designs), are discussed, along with the ultimate goal of gaining US Food and Drug Administration approval for prostate-cancer preventive agents that can improve public health by reducing prostate cancer incidence and mortality.

    Original languageEnglish (US)
    Pages (from-to)205-212
    Number of pages8
    JournalUrology
    Volume57
    Issue number4 SUPPL. 1
    DOIs
    StatePublished - Jan 1 2001

    ASJC Scopus subject areas

    • Urology

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  • Cite this

    Lee, J. J., Lieberman, R., Sloan, J. A., Piantadosi, S., & Lippman, S. M. (2001). Design considerations for efficient prostate cancer chemoprevention trials. Urology, 57(4 SUPPL. 1), 205-212. https://doi.org/10.1016/s0090-4295(00)00976-6