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Original Contribution
January 7, 2009

Effect of Selenium and Vitamin E on Risk of Prostate Cancer and Other Cancers: The Selenium and Vitamin E Cancer Prevention Trial (SELECT)

Author Affiliations

Author Affiliations: Divisions of Cancer Medicine (Drs Lippman and Karp) and Cancer Prevention and Population Sciences (Drs Lippman and Cook), University of Texas M. D. Anderson Cancer Center, Houston; Glickman Urological and Kidney Institute and Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio (Dr Klein); Southwest Oncology Group Statistical Center, Seattle, Washington (Dr Crowley and Mss P. Goodman, Hartline, Darke, and Arnold); Department of Pathology (Dr Lucia) and Division of Urologic Oncology (Dr Crawford), University of Colorado Health Sciences Center, Denver; Departments of Urology (Dr Thompson) and Medicine/Hematology and Medical Oncology (Dr Coltman), University of Texas Health Sciences Center, San Antonio; Division of Cancer Prevention (Drs Ford, Parnes, and Minasian) and Division of Cancer Epidemiology and Genetics (Drs Albanes and Taylor), National Cancer Institute, Bethesda, Maryland; Veterans Affairs Cooperative Studies Program and Massachusetts Veterans Epidemiology Research and Information Center, Boston VA Healthcare Center, Boston, Massachusetts (Dr Gaziano); Moores Cancer Center, La Jolla, California (Dr Parsons); Upstate Carolina CCOP, Spartanburg, South Carolina (Dr Bearden); Division of Hematology and Oncology, Swedish Cancer Institute, Seattle, Washington (Dr G. Goodman); Altamira Family Medicine, Rio Piedras, Puerto Rico (Dr Claudio); London Regional Cancer Program, London Health Sciences Center, London, Ontario, Canada (Dr Winquist); Department of Urologic Surgery, Duke University Medical Center, Durham, North Carolina (Dr Walther); Department of Urology, Mayo Clinic, Rochester, Minnesota (Dr Lieber); Departments of Epidemiology (Dr Kristal) and Medicine and Cardiology (Dr Probstfield), University of Washington, Seattle; Division of Cancer Prevention and Control Research, Jonsson Comprehensive Cancer Center, University of California, Los Angeles (Dr Ganz); Mailman School of Public Health, Columbia University, New York, New York (Dr Santella); Center for Clinical Epidemiology and Evaluation, University of British Columbia, Vancouver, Canada (Mr Jagpal); Chao Family Comprehensive Cancer Center, University of California at Irvine, Orange (Dr Meyskens); and Division of Hematology and Oncology, University of Michigan (Dr Baker), and Southwest Oncology Group (Drs Baker and Coltman), Ann Arbor, Michigan.

JAMA. 2009;301(1):39-51. doi:10.1001/jama.2008.864
Abstract

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 μg/d from L-selenomethionine) and matched vitamin E placebo, vitamin E (400 IU/d of all rac-α-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

Trial Registration Published online December 9, 2008 (doi:10.1001/jama.2008.864).

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