title: Decision analysis of dutasteride use for patients with negative prostate biopsy.
abstract: OBJECTIVE
  To determine whether the additional benefits of improved prostate cancer detection associated with 5α-reductase inhibitors are sufficient to warrant chemoprevention in the case where the degree of prostate cancer risk reduction is deemed inadequate.
  
  
  METHODS
  We reanalyzed data from REDUCE, a randomized trial of dutasteride for prostate cancer chemoprevention in men with prior negative biopsy. We evaluated whether statistical models using prostate-specific antigen (PSA) and PSA velocity could help predict the result of repeat prostate biopsy separately for dutasteride and placebo groups. Area under the curve was evaluated by 10-fold cross-validation.
  
  
  RESULTS
  PSA velocity improved discrimination at 4 years in the dutasteride group but not at 2 years nor in the placebo group. At 2 years, dutasteride improved discrimination of PSA slightly (0.616 vs. 0.603 for any grade cancer; 0.681 vs. 0.676 for high-grade disease). Between-group differences in cancer rates at 4 years were small.
  
  
  CONCLUSIONS
  Clinicians who are willing to treat at least 23 patients with dutasteride for 2 years to avoid 1 prostate cancer diagnosis should offer dutasteride after initial negative biopsy. Clinicians not willing to do so might consider dutasteride for its additional benefit of reducing unnecessary biopsy, although this benefit is apparent only under very restrictive conditions. It is difficult to justify extending treatment with dutasteride for >2 years.
authors.affiliation: Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY. Electronic address: vickersa@mskcc.org.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Vickers
authors.affiliation: Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY.
authors.forename: Daniel D
authors.initials: DD
authors.lastname: Sjoberg
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000627:therapeutic use*; D000368:Aged; D001378:Azasteroids / Q000627:therapeutic use*; D001706:Biopsy; D003661:Decision Support Techniques; D000068538:Dutasteride; D006801:Humans; D008297:Male; D008875:Middle Aged; D011467:Prostate / Q000473:pathology; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000517:prevention & control*
chemical_list: D058891:5-alpha Reductase Inhibitors; D001378:Azasteroids; D017430:Prostate-Specific Antigen; D000068538:Dutasteride