Abstract | CONTEXT: OBJECTIVE: DESIGN, SETTING, AND PARTICIPANTS: A total of 35,533 men from 427 study sites in the United States, Canada, and Puerto Rico were randomized between August 22, 2001, and June 24, 2004. Eligibility criteria included a prostate-specific antigen (PSA) of 4.0 ng/mL or less, a digital rectal examination not suspicious for prostate cancer, and age 50 years or older for black men and 55 years or older for all others. The primary analysis included 34,887 men who were randomly assigned to 1 of 4 treatment groups: 8752 to receive selenium; 8737, vitamin E; 8702, both agents, and 8696, placebo. Analysis reflect the final data collected by the study sites on their participants through July 5, 2011. INTERVENTIONS: MAIN OUTCOME MEASURES: RESULTS: This report includes 54,464 additional person-years of follow-up and 521 additional cases of prostate cancer since the primary report. Compared with the placebo (referent group) in which 529 men developed prostate cancer, 620 men in the vitamin E group developed prostate cancer (hazard ratio [HR], 1.17; 99% CI, 1.004-1.36, P = .008); as did 575 in the selenium group (HR, 1.09; 99% CI, 0.93-1.27; P = .18), and 555 in the selenium plus vitamin E group (HR, 1.05; 99% CI, 0.89-1.22, P = .46). Compared with placebo, the absolute increase in risk of prostate cancer per 1000 person-years was 1.6 for vitamin E, 0.8 for selenium, and 0.4 for the combination. CONCLUSION: TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00006392.
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Authors | Eric A Klein, Ian M Thompson Jr, Catherine M Tangen, John J Crowley, M Scott Lucia, Phyllis J Goodman, Lori M Minasian, Leslie G Ford, Howard L Parnes, J Michael Gaziano, Daniel D Karp, Michael M Lieber, Philip J Walther, Laurence Klotz, J Kellogg Parsons, Joseph L Chin, Amy K Darke, Scott M Lippman, Gary E Goodman, Frank L Meyskens Jr, Laurence H Baker |
Journal | JAMA
(JAMA)
Vol. 306
Issue 14
Pg. 1549-56
(Oct 12 2011)
ISSN: 1538-3598 [Electronic] United States |
PMID | 21990298
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Chemical References |
- Antioxidants
- Vitamin E
- Selenium
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Topics |
- Aged
- Antioxidants
(administration & dosage, adverse effects)
- Dietary Supplements
(adverse effects)
- Follow-Up Studies
- Humans
- Incidence
- Male
- Middle Aged
- Prostatic Neoplasms
(epidemiology, prevention & control)
- Risk
- Selenium
(administration & dosage)
- Vitamin E
(administration & dosage, adverse effects)
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