title: Alcohol intake increases high-grade prostate cancer risk among men taking dutasteride in the REDUCE trial.
abstract: BACKGROUND
  Although most studies found no association between alcohol intake and prostate cancer (PCa) risk, an analysis of the Prostate Cancer Prevention Trial found that high alcohol intake significantly increased PCa risk among men randomized to the 5α-reductase inhibitor (5-ARI) finasteride.
  
  
  OBJECTIVE
  Determine whether alcohol affects PCa risk among men taking the 5-ARI dutasteride.
  
  
  METHODS
  Reduction by Dutasteride of Prostate Cancer Events was a 4-yr, multicenter, randomized, double-blind, placebo-controlled trial to compare PCa after dutasteride administration (0.5mg/d) with placebo. Participants had a baseline prostate-specific antigen between 2.5 and 10.0 ng/ml and a recent negative prostate biopsy. Alcohol intake was determined by baseline questionnaire, and participants underwent a prostate biopsy to determine PCa status at 2 yr and 4 yr of follow-up.
  
  
  METHODS
  Multivariable logistic regression was used to calculate odds ratios (ORs) and 95% confidence intervals (CIs) for the associations between alcohol intake and low-grade (Gleason <7) and high-grade (Gleason >7) PCa.
  
  
  CONCLUSIONS
  Of 6374 participants in our analysis, approximately 25% reported no alcohol consumption, 49% were moderate drinkers (one to seven drinks per week), and 26% were heavy drinkers (more than seven drinks per week). Alcohol intake was not associated with low- or high-grade PCa in the placebo arm and was not associated with low-grade PCa among men taking dutasteride. In contrast, men randomized to dutasteride and reporting more than seven drinks per week were 86% more likely to be diagnosed with high-grade PCa (p=0.01). Among alcohol abstainers, dutasteride was associated with significantly reduced risk of high-grade PCa (OR: 0.59; 95% CI, 0.38-0.90), but dutasteride was no longer associated with reduced high-grade PCa among men reporting high alcohol intake (OR: 0.99; 95% CI, 0.67-1.45).
  
  
  CONCLUSIONS
  Alcohol consumption negated a protective association between dutasteride and high-grade PCa.
  
  
  RESULTS
  We confirmed a prior study that alcohol affects PCa prevention in patients taking 5-ARIs. Patients taking 5-ARIs may wish to eliminate alcohol intake if they are concerned about PCa.
authors.affiliation: Division of Epidemiology, Departments of Medicine and Department of Surgical Urology, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: jay.fowke@vanderbilt.edu.
authors.forename: Jay H
authors.initials: JH
authors.lastname: Fowke
authors.affiliation: Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA; Urology Section, Veterans Affairs Medical Center, Durham, NC, USA.
authors.forename: Lauren
authors.initials: L
authors.lastname: Howard
authors.affiliation: Division of Urology, Washington University School of Medicine in St. Louis, St. Louis, MO, USA.
authors.forename: Gerald L
authors.initials: GL
authors.lastname: Andriole
authors.affiliation: Urology Section, Veterans Affairs Medical Center, Durham, NC, USA; Duke Prostate Center, Division of Urology, Department of Surgery and Pathology, Duke University School of Medicine, Durham, NC, USA.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Freedland
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000627:therapeutic use*; D000368:Aged; D000428:Alcohol Drinking / Q000009:adverse effects*; D001706:Biopsy; D004311:Double-Blind Method; D000068538:Dutasteride / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D011467:Prostate / Q000473:pathology*; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000473:pathology* / Q000517:prevention & control*; D012307:Risk Factors
chemical_list: D058891:5-alpha Reductase Inhibitors; D017430:Prostate-Specific Antigen; D000068538:Dutasteride
keywords: Alcohol trial; Dutasteride; Prostate cancer