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Design and Progress of a Trial of Selenium to Prevent Prostate Cancer among Men with High-Grade Prostatic Intraepithelial Neoplasia

¹ Roswell Park Cancer Institute, Buffalo, New York; ² Wayne State University, Detroit; ³ University of Michigan, Ann Arbor, Michigan; ⁴ University of Washington; ⁵ Fred Hutchinson Cancer Research Center, Seattle, Washington; ⁶ University of Texas Health Science Center, San Antonio; ⁷ M.D. Anderson Cancer Center, Houston, Texas; ⁸ National Cancer Institute, Bethesda, Maryland; ⁹ Arizona Cancer Center, Tucson, Arizona; ¹⁰ University of Wisconsin, Madison, Wisconsin; ¹¹ Cancer Therapy and Research Center, San Antonio, Texas; and ¹² University of Colorado Health Sciences Center, Aurora, Colorado

Requests for reprints: James R. Marshall, Roswell Park Cancer Institute, Buffalo, NY 14263. Phone: 716-845-8444; Fax: 716-845-8487. E-mail: james.marshall{at}roswellpark.org

High-grade prostatic intraepithelial neoplasia (HGPIN) is generally regarded as a premalignant lesion that progresses toward prostate cancer. In light of the significant sequelae of prostate cancer treatment, prevention is desirable, and men with HGPIN would be suitable, high-risk subjects. There is in vitro, in vivo, epidemiologic, and human experimental evidence that selenium supplementation may protect against prostate cancer. This article introduces the rationale for, and progress to date, of a double-blind, randomized, placebo-controlled trial of selenium supplementation (200 µg/d in the form of selenomethionine), to prevent the development of prostate cancer among men with HGPIN. The trial, Southwest Oncology Group Protocol 9917, funded by a National Cancer Institute program supporting pivotal prevention trials has registered 537 patients and has randomized >380 to date. Subject accrual is expected to be completed by the fall of 2006, with trial completion in 2009. (Cancer Epidemiol Biomarkers Prev 2006;15(8):1479–84)

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