title: Health-related quality-of-life findings for the prostate cancer prevention trial.
abstract: BACKGROUND
  The Prostate Cancer Prevention Trial (PCPT)-a randomized placebo-controlled study of the efficacy of finasteride in preventing prostate cancer-offered the opportunity to prospectively study effects of finasteride and other covariates on the health-related quality of life of participants in a multiyear trial.
  
  
  METHODS
  We assessed three health-related quality-of-life domains (measured with the Health Survey Short Form-36: Physical Functioning, Mental Health, and Vitality scales) via questionnaires completed by PCPT participants at enrollment (3 months before randomization), at 6 months after randomization, and annually for 7 years. Covariate data obtained at enrollment from patient-completed questionnaires were included in our model. Mixed-effects model analyses and a cross-sectional presentation at three time points began at 6 months after randomization. All statistical tests were two-sided.
  
  
  RESULTS
  For the physical function outcome (n = 16 077), neither the finasteride main effect nor the finasteride interaction with time were statistically significant. The effects of finasteride on physical function were minor and accounted for less than a 1-point difference over time in Physical Functioning scores (mixed-effect estimate = 0.07, 95% confidence interval [CI] = -0.28 to 0.42, P = .71). Comorbidities such as congestive heart failure (estimate = -5.64, 95% CI = -7.96 to -3.32, P < .001), leg pain (estimate = -2.57, 95% CI = -3.04 to -2.10, P < .001), and diabetes (estimate = -1.31, 95% CI = -2.04 to -0.57, P < .001) had statistically significant negative effects on physical function, as did current smoking (estimate = -2.34, 95% CI = -2.97 to -1.71, P < .001) and time on study (estimate = -1.20, 95% CI = -1.36 to -1.03, P < .001). Finasteride did not have a statistically significant effect on the other two dependent variables, mental health and vitality, either in the mixed-effects analyses or in the cross-sectional analysis at any of the three time points.
  
  
  CONCLUSIONS
  Finasteride did not negatively affect SF-36 Physical Functioning, Mental Health, or Vitality scores.
authors.affiliation: Public Health Sciences Division, Fred Hutchinson Cancer Research Center, M3-C102 1100 Fairview Ave North, PO Box 19024 Seattle, WA 98109-1024, USA. cmoinpou@fhcrc.org
authors.forename: Carol M
authors.initials: CM
authors.lastname: Moinpour
authors.forename: Amy K
authors.initials: AK
authors.lastname: Darke
authors.forename: Gary W
authors.initials: GW
authors.lastname: Donaldson
authors.forename: Duane
authors.initials: D
authors.lastname: Cespedes
authors.forename: Christine R
authors.initials: CR
authors.lastname: Johnson
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Ganz
authors.forename: Donald L
authors.initials: DL
authors.lastname: Patrick
authors.forename: John E
authors.initials: JE
authors.lastname: Ware
authors.forename: Sally A
authors.initials: SA
authors.lastname: Shumaker
authors.forename: Frank L
authors.initials: FL
authors.lastname: Meyskens
authors.forename: Ian M
authors.initials: IM
authors.lastname: Thompson
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D000203:Activities of Daily Living; D000368:Aged; D016588:Anticarcinogenic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D018120:Finasteride / Q000494:pharmacology / Q000627:therapeutic use*; D006304:Health Status; D006801:Humans; D008297:Male; D008603:Mental Health; D008875:Middle Aged; D015233:Models, Statistical; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000517:prevention & control*; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D058891:5-alpha Reductase Inhibitors; D016588:Anticarcinogenic Agents; D018120:Finasteride