Progression From High-Grade Prostatic Intraepithelial Neoplasia to Cancer: A Randomized Trial of Combination Vitamin-E, Soy, and Selenium

Fleshner, Neil; Kapusta, Linda; Donnelly, Bryan J.; Tanguay, Simon; Chin, Joseph L.; Hersey, Karen; Farley, A; Jansz, Ken; Siemens, D. Robert; Trpkov, Kiril; Lacombe, Louis; Gleave, Martin; Tu, Dongsheng; Parulekar, Wendy R.

doi:10.1200/jco.2010.32.0994

Cited by 67 publications

(54 citation statements)

References 22 publications

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“…Similar to this study, selenium, lycopene and soy have also not shown to reduce the risk of prostate cancer 1 2. However, the findings of the present study are inconsistent with two other contemporary studies.…”

Section: Commentarycontrasting

confidence: 59%

Vitamin E increases prostate cancer risk in middle-aged men relative to placebo: no significant association observed with selenium, either alone or in combination with vitamin E

Wyatt

2012

Evid Based Nurs

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Vitamin E increases prostate cancer risk in middle-aged men relative to placebo: no significant association observed with selenium, either alone or in combination with vitamin E Gwen Wyatt Implications for practice and researchClinicians should inform patients that vitamin E sig-■ nifi cantly increased the risk of prostate cancer among healthy men, and should be avoided. Extended follow-up of common doses of vitamins and ■ supplements may reveal new and critically signifi cant fi ndings.

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Section: Commentarycontrasting

confidence: 59%

Vitamin E increases prostate cancer risk in middle-aged men relative to placebo: no significant association observed with selenium, either alone or in combination with vitamin E

Wyatt

2012

Evid Based Nurs

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“…Other randomized studies have shown no benefit to dietary supplementation with selenium, lycopene, or soy in reducing the risk of risk of invasive cancer in men with high-grade prostatic intraepithelial neoplasia (HGPIN) on biopsy. 13,14 In this report we detail an observation of serious public health concern that has emerged with continued follow-up of SELECT participants. With primary endpoint ascertainment based on contemporary community practice across the US, Canada, and Puerto Rico using PSA and DRE as indications for biopsy, the risk of prostate cancer at 7 years of median follow-up was increased by 17% in men randomized to supplementation with vitamin E alone a difference which started to appear about two years post randomization.…”

Section: Commentmentioning

confidence: 99%

Vitamin E and the risk of prostate cancer: Updated results of the Selenium and Vitamin E Cancer Prevention Trial (SELECT).

Klein

Thompson

Tangen

et al. 2012

JCO

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124

154

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Context-The initial report of the Selenium and Vitamin E Cancer Prevention Trial (SELECT) found no reduction in risk of prostate cancer with either selenium or vitamin E supplements but a non-statistically significant increase in prostate cancer risk with vitamin E. Longer follow-up and more prostate cancer events provide further insight into the relationship of vitamin E and prostate cancer.Objective-To determine the long-term effect of vitamin E and selenium on risk of prostate cancer in relatively healthy men.Design, Setting and Participants-SELECT randomized 35,533 men from 427 study sites in the United States, Canada and Puerto Rico in a double-blind manner between August 22, 2001 and June 24, 2004. Eligible men were 50 years or older (African Americans) or 55 years or older (all others) with a PSA ≤4.0 ng/mL and a digital rectal examination not suspicious for prostate cancer. Included in the analysis are 34,887 men randomly assigned to one of four treatment groups: selenium (n=8752), vitamin E (n=8737), both agents (n=8702), or placebo (n=8696). Data reflect the final data collected by the study sites on their participants through July 5, 2011.Interventions-Oral selenium (200 μg/day from L-selenomethionine) with matched vitamin E placebo, vitamin E (400 IU/d of all rac-α-tocopheryl acetate) with matched selenium placebo, both agents, or both matched placebos for a planned follow-up of a minimum of 7 and maximum of 12 years. Main Outcome Measures-Prostate cancer incidence.Results-This report includes 54,464 additional person-years of follow-up since the primary report. Hazard ratios (99% confidence intervals [CI]) and numbers of prostate cancers were 1.17(99% CI 1.004-1.36, p=.008, n=620) for vitamin E, 1.09 (99% CI 0.93-1.27, p=.18, n=575) for selenium, 1.05 (99%CI 0.89-1.22, p=.46, n=555) for selenium + vitamin E vs. 1.00 (n=529) for placebo.The absolute increase in risk compared with placebo for vitamin E, selenium and the combination were 1.6, 0.9 and 0.4 cases of prostate cancer per 1,000 person-years.Conclusions-Dietary supplementation with Vitamin E significantly increases the risk of prostate cancer among healthy men. Trial registration-clinicaltrials.gov identifier: NCT00006392Lifetime risk of prostate cancer in the United Sates is currently estimated to be 16%. 1 While most cases are found at an early, curable stage, treatment is costly and urinary, sexual, and bowel-related side effects are common. 2 Even men who choose active surveillance as an initial management strategy face anxiety, uncertain prognosis, and a measurable risk of sepsis with follow-up biopsies 3 , and more than one-third of those who initially defer therapy are ultimately treated. 4,5 With such a high prevalence, risk of morbidity from treatment, and treatment-related costs, primary prevention of prostate cancer is an attractive option.With considerable preclinical and epidemiologic evidence that selenium and vitamin E may reduce prostate cancer risk, we conducted and reported the results of a prospective were not st...

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Section: Commentmentioning

confidence: 99%

Vitamin E and the Risk of Prostate Cancer

Klein¹,

Thompson²,

Tangen³

et al. 2011

JAMA

1,513

469

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Context The initial report of the Selenium and Vitamin E Cancer Prevention Trial (SELECT) found no reduction in risk of prostate cancer with either selenium or vitamin E supplements but a non-statistically significant increase in prostate cancer risk with vitamin E. Longer follow-up and more prostate cancer events provide further insight into the relationship of vitamin E and prostate cancer. Objective To determine the long-term effect of vitamin E and selenium on risk of prostate cancer in relatively healthy men. Design, Setting and Participants SELECT randomized 35,533 men from 427 study sites in the United States, Canada and Puerto Rico in a double-blind manner between August 22, 2001 and June 24, 2004. Eligible men were 50 years or older (African Americans) or 55 years or older (all others) with a PSA ≤4.0 ng/mL and a digital rectal examination not suspicious for prostate cancer. Included in the analysis are 34,887 men randomly assigned to one of four treatment groups: selenium (n=8752), vitamin E (n=8737), both agents (n=8702), or placebo (n=8696). Data reflect the final data collected by the study sites on their participants through July 5, 2011. Interventions Oral selenium (200 μg/day from L-selenomethionine) with matched vitamin E placebo, vitamin E (400 IU/d of all rac-α-tocopheryl acetate) with matched selenium placebo, both agents, or both matched placebos for a planned follow-up of a minimum of 7 and maximum of 12 years. Main Outcome Measures Prostate cancer incidence. Results This report includes 54,464 additional person-years of follow-up since the primary report. Hazard ratios (99% confidence intervals [CI]) and numbers of prostate cancers were 1.17(99% CI 1.004-1.36, p=.008, n=620) for vitamin E, 1.09 (99% CI 0.93-1.27, p=.18, n=575) for selenium, 1.05 (99%CI 0.89-1.22, p=.46, n=555) for selenium + vitamin E vs. 1.00 (n=529) for placebo.The absolute increase in risk compared with placebo for vitamin E, selenium and the combination were 1.6, 0.9 and 0.4 cases of prostate cancer per 1,000 person-years. Conclusions Dietary supplementation with Vitamin E significantly increases the risk of prostate cancer among healthy men. Trial registration clinicaltrials.gov identifier: NCT00006392

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Progression From High-Grade Prostatic Intraepithelial Neoplasia to Cancer: A Randomized Trial of Combination Vitamin-E, Soy, and Selenium

Abstract: This trial does not support the hypothesis that combination vitamin E, selenium, and soy prevents progression from HGPIN to PCa.

Cited by 67 publications

References 22 publications

Vitamin E increases prostate cancer risk in middle-aged men relative to placebo: no significant association observed with selenium, either alone or in combination with vitamin E

Vitamin E increases prostate cancer risk in middle-aged men relative to placebo: no significant association observed with selenium, either alone or in combination with vitamin E

Vitamin E and the risk of prostate cancer: Updated results of the Selenium and Vitamin E Cancer Prevention Trial (SELECT).

Vitamin E and the Risk of Prostate Cancer

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