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.
Conclusion: Finasteride did not negatively affect SF-36 Physical Functioning, Mental Health, or Vitality scores.
Written by:
Moinpour CM, Darke AK, Donaldson GW, Cespedes D, Johnson CR, Ganz PA, Patrick DL, Ware JE Jr, Shumaker SA, Meyskens FL, Thompson IM Jr. Are you the author?
Public Health Sciences Division, Fred Hutchinson Cancer Research Center, M3-C102 1100 Fairview Ave North, PO Box 19024 Seattle, WA 98109-1024.
Reference: J Natl Cancer Inst. 2012 Sep 19;104(18):1373-85.
doi: 10.1093/jnci/djs359
PubMed Abstract
PMID: 22972968
UroToday.com Prostate Cancer Section
