Effect of Selenium and Vitamin E on Risk of Prostate Cancer and Other Cancers: The Selenium and Vitamin E Cancer Prevention Trial (SELECT).
Lippman, Scott M. MD; Klein, Eric A. MD; Goodman, Phyllis J. MS; Lucia, M. Scott MD; Thompson, Ian M. MD; Ford, Leslie G. MD; Parnes, Howard L. MD; Minasian, Lori M. MD; Gaziano, J. Michael MD, MPH; Hartline, Jo Ann MPH; Parsons, J. Kellogg MD, MHS; Bearden, James D. III MD; Crawford, E. David MD; Goodman, Gary E. MD; Claudio, Jaime MD; Winquist, Eric MD, MSc; Cook, Elise D. MD; Karp, Daniel D. MD; Walther, Philip MD; Lieber, Michael M. MD; Kristal, Alan R. DrPH; Darke, Amy K. MS; Arnold, Kathryn B. MS; Ganz, Patricia A. MD; Santella, Regina M. PhD; Albanes, Demetrius MD; Taylor, Philip R. MD, ScD; Probstfield, Jeffrey L. MD; Jagpal, T. J. CCRP; Crowley, John J. PhD; Meyskens, Frank L. Jr MD; Baker, Laurence H. DO; Coltman, Charles A. Jr MD
[Article]
JAMA.
301(1):39-51, January 7, 2009.
(Format: HTML, PDF)
Context: Secondary analyses of 2 randomized controlled trials and supportive epidemiologic and preclinical data indicated the potential of selenium and vitamin E for preventing prostate cancer.
Objective: To determine whether selenium, vitamin E, or both could prevent prostate cancer and other diseases with little or no toxicity in relatively healthy men.
Design, Setting, and Participants: A randomized, placebo-controlled trial (Selenium and Vitamin E Cancer Prevention Trial [SELECT]) of 35 533 men from 427 participating sites in the United States, Canada, and Puerto Rico randomly assigned to 4 groups (selenium, vitamin E, selenium vitamin E, and placebo) in a double-blind fashion between August 22, 2001, and June 24, 2004. Baseline eligibility included age 50 years or older (African American men) or 55 years or older (all other men), a serum prostate-specific antigen level of 4 ng/mL or less, and a digital rectal examination not suspicious for prostate cancer.
Interventions: Oral selenium (200 [mu]g/d from L-selenomethionine) and matched vitamin E placebo, vitamin E (400 IU/d of all rac-[alpha]-tocopheryl acetate) and matched selenium placebo, selenium vitamin E, or placebo placebo for a planned follow-up of minimum of 7 years and a maximum of 12 years.
Main Outcome Measures: Prostate cancer and prespecified secondary outcomes, including lung, colorectal, and overall primary cancer.
Results: As of October 23, 2008, median overall follow-up was 5.46 years (range, 4.17-7.33 years). Hazard ratios (99% confidence intervals [CIs]) for prostate cancer were 1.13 (99% CI, 0.95-1.35; n = 473) for vitamin E, 1.04 (99% CI, 0.87-1.24; n = 432) for selenium, and 1.05 (99% CI, 0.88-1.25; n = 437) for selenium vitamin E vs 1.00 (n = 416) for placebo. There were no significant differences (all P>.15) in any other prespecified cancer end points. There were statistically nonsignificant increased risks of prostate cancer in the vitamin E group (P = .06) and type 2 diabetes mellitus in the selenium group (relative risk, 1.07; 99% CI, 0.94-1.22; P = .16) but not in the selenium vitamin E group.
Conclusion: Selenium or vitamin E, alone or in combination at the doses and formulations used, did not prevent prostate cancer in this population of relatively healthy men.
Trial Registration: clinicaltrials.gov identifier: NCT00006392
Published online December 9, 2008 (doi:10.1001/jama.2008.864).
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