title: Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT).
abstract: BACKGROUND
  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 statistically nonsignificant 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.
  
  
  METHODS
  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.
  
  
  METHODS
  Oral selenium (200 μg/d 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.
  
  
  METHODS
  Prostate cancer incidence.
  
  
  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.
  
  
  CONCLUSIONS
  Dietary supplementation with vitamin E significantly increased the risk of prostate cancer among healthy men.
  
  
  BACKGROUND
  Clinicaltrials.gov Identifier: NCT00006392.
authors: Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio 44195, USA. kleine@ccf.org
authors: Eric A
authors: EA
authors: Klein
authors: Ian M
authors: IM
authors: Thompson
authors: Catherine M
authors: CM
authors: Tangen
authors: John J
authors: JJ
authors: Crowley
authors: M Scott
authors: MS
authors: Lucia
authors: Phyllis J
authors: PJ
authors: Goodman
authors: Lori M
authors: LM
authors: Minasian
authors: Leslie G
authors: LG
authors: Ford
authors: Howard L
authors: HL
authors: Parnes
authors: J Michael
authors: JM
authors: Gaziano
authors: Daniel D
authors: DD
authors: Karp
authors: Michael M
authors: MM
authors: Lieber
authors: Philip J
authors: PJ
authors: Walther
authors: Laurence
authors: L
authors: Klotz
authors: J Kellogg
authors: JK
authors: Parsons
authors: Joseph L
authors: JL
authors: Chin
authors: Amy K
authors: AK
authors: Darke
authors: Scott M
authors: SM
authors: Lippman
authors: Gary E
authors: GE
authors: Goodman
authors: Frank L
authors: FL
authors: Meyskens
authors: Laurence H
authors: LH
authors: Baker
mesh_terms: D000368:Aged; D000975:Antioxidants / Q000008:administration & dosage / Q000009:adverse effects*; D019587:Dietary Supplements / Q000009:adverse effects*; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000453:epidemiology* / Q000517:prevention & control; D012306:Risk; D012643:Selenium / Q000008:administration & dosage*; D014810:Vitamin E / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D000975:Antioxidants; D014810:Vitamin E; D012643:Selenium