Richard M. Hoffman, MD, MPH
In healthy middle-aged and older men, does supplementation with selenium, vitamin E, or both decrease risk for prostate cancer?
Randomized placebo-controlled trial. ClinicalTrials.gov NCT00006392.
Blinded (participants, clinicians, data collectors, and outcome assessors).*
Median 5.5 years (trial was stopped early for apparent lack of benefit).
427 sites in the USA, Canada, and Puerto Rico.
35 533 men ≥ 55 years of age (≥ 50 y if African American) (median age 62 y) who had no previous prostate cancer diagnosis, serum prostate-specific antigen level ≥ 4 ng/mL, negative digital rectal examination, no current use of anticoagulant therapy, no history of hemorrhagic stroke, and normal blood pressure.
Selenium, 200 µg/d, plus placebo for vitamin E (n = 8910); vitamin E, 400 IU/d, plus placebo for selenium (n = 8904); selenium plus vitamin E (n = 8863); or double placebo (n = 8856). Annual prostate cancer screening was recommended according to local standard of care and participant preference but was not mandatory.
Primary outcome was incidence of prostate cancer as determined by routine clinical management. Secondary outcomes included lung cancer, colorectal cancer, other primary cancers, new-onset diabetes, cardiovascular events, and death from all causes. The trial had 96% power to detect a 25% relative reduction in prostate cancer (1-sided α = 0.005).
94% (intention-to-treat analysis).
Adherence to study medications was 83% at 1 year and 65% at 5 years. The selenium, vitamin E, and selenium plus vitamin E groups did not differ from the placebo group for prostate cancer (Table) or any secondary outcome.
In healthy middle-aged and older men, supplementation with selenium, vitamin E, or their combination did not decrease risk for prostate cancer.
Selenium, vitamin E, or their combination vs placebo to prevent prostate cancer†
†Abbreviations defined in Glossary. RRI and CI calculated from hazard ratios in article.
Hoffman RM. Selenium and vitamin E, alone or together, did not prevent prostate cancer. Ann Intern Med. ;150:JC3–10. doi: 10.7326/0003-4819-150-6-200903170-02010
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Published: Ann Intern Med. 2009;150(6):JC3-10.
Hematology/Oncology, Prevention/Screening, Prostate Cancer.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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