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JNCI Journal of the National Cancer Institute 2005 97(2):94-102; doi:10.1093/jnci/dji009
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© 2005 Oxford University Press

COMMENTARY

Designing the Selenium and Vitamin E Cancer Prevention Trial (SELECT)

Scott M. Lippman, Phyllis J. Goodman, Eric A. Klein, Howard L. Parnes, Ian M. Thompson, Jr, Alan R. Kristal, Regina M. Santella, Jeffrey L. Probstfield, Carol M. Moinpour, Demetrius Albanes, Philip R. Taylor, Lori M. Minasian, Ashraful Hoque, Sarah Moody Thomas, John J. Crowley, J. Michael Gaziano, Janet L. Stanford, Elise D. Cook, Neil E. Fleshner, Michael M. Lieber, Philip J. Walther, Fadlo R. Khuri, Daniel D. Karp, Gary G. Schwartz, Leslie G. Ford, Charles A. Coltman, Jr

Affiliation of authors: The University of Texas M.D. Anderson Cancer Center, Houston, TX (SML, AH, EDC); Southwest Oncology Group Statistical Center, Seattle, WA (PJG, CMM, JJC); Cleveland Clinic Foundation, Cleveland, OH (EAK); National Cancer Institute, Bethesda, MD (HLP, DA, PRT, LMM, LGF); University of Texas Health Science Center at San Antonio, San Antonio, TX (IMT); Fred Hutchinson Cancer Research Center, Seattle, WA (ARK, JLS); Columbia University College of Physicians and Surgeons, New York, NY (RMS); University of Washington, Seattle, WA (JLP); Louisiana State University Health Science Center, New Orleans, LA (SMT); Boston VA Healthcare System, Boston, MA (JMG); Canadian Urologic Oncology Group, Toronto, ON, Canada (NEF); North Central Cancer Treatment Group, Rochester, MN (MML); Cancer and Leukemia Group B, Chicago, IL (PJW); Radiation Therapy Oncology Group, Philadelphia, PA (FRK); Eastern Cooperative Oncology Group, Brookline, MA (DDK); Wake Forest University School of Medicine, Winston-Salem, NC (GGS); Southwest Oncology Group Operations Office, San Antonio, TX (CAC)

Correspondence to: Scott M. Lippman, MD, M. D. Anderson Cancer Center, Department of Clinical Cancer Prevention, Rm. HMB 11.192, Box 236, 1515 Holcombe Blvd., Houston, TX 77030-4009 (e-mail: slippman{at}mdanderson.org)

Prostate cancer continues to be a major health threat, especially among African American men. The Selenium and Vitamin E Cancer Prevention Trial (SELECT), which opened on July 25, 2001, was planned to study possible agents for the prevention of prostate cancer in a population of 32 400 men in the United States, including Puerto Rico, and Canada. SELECT is a phase III randomized, placebo-controlled trial of selenium (200 µg/day from L-selenomethionine) and/or vitamin E (400 IU/day of all rac {alpha}-tocopheryl acetate) supplementation for a minimum of 7 years (maximum of 12 years) in non–African American men at least 55 years of age and African American men at least 50 years of age. SELECT is a large, simple trial that conforms as closely as possible with community standards of care. This commentary discusses the design problems the SELECT investigators had to resolve in developing the trial, including the role of prostate cancer screening, the best forms and doses of the study agents, and estimation of the event (prostate cancer) rate of men on the placebo arm.


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