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-36Physical Functioning, Mental Health, or Vitality scores.
RCT Entities:
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.
Authors: J Kellogg Parsons; Jeannette M Schenk; Kathryn B Arnold; Karen Messer; Cathee Till; Ian M Thompson; Alan R Kristal Journal: Eur Urol Date: 2012-03-14 Impact factor: 20.096
Authors: C M Moinpour; L C Lovato; I M Thompson; J E Ware; P A Ganz; D L Patrick; S A Shumaker; G W Donaldson; A Ryan; C A Coltman Journal: J Clin Oncol Date: 2000-05 Impact factor: 44.544
Authors: Mary W Redman; Catherine M Tangen; Phyllis J Goodman; M Scott Lucia; Charles A Coltman; Ian M Thompson Journal: Cancer Prev Res (Phila) Date: 2008-05-18
Authors: Ian M Thompson; Phyllis J Goodman; Catherine M Tangen; M Scott Lucia; Gary J Miller; Leslie G Ford; Michael M Lieber; R Duane Cespedes; James N Atkins; Scott M Lippman; Susie M Carlin; Anne Ryan; Connie M Szczepanek; John J Crowley; Charles A Coltman Journal: N Engl J Med Date: 2003-06-24 Impact factor: 91.245
Authors: J Kellogg Parsons; Jolee Mougey; Lori Lambert; Timothy J Wilt; Howard A Fink; Mark Garzotto; Elizabeth Barrett-Connor; Lynn M Marshall Journal: BJU Int Date: 2009-01-19 Impact factor: 5.588
Authors: Blayne Welk; Eric McArthur; Michael Ordon; Kelly K Anderson; Jade Hayward; Stephanie Dixon Journal: JAMA Intern Med Date: 2017-05-01 Impact factor: 21.873
Authors: Joseph M Unger; Cathee Till; Ian M Thompson; Catherine M Tangen; Phyllis J Goodman; Jason D Wright; William E Barlow; Scott D Ramsey; Lori M Minasian; Dawn L Hershman Journal: J Natl Cancer Inst Date: 2016-08-26 Impact factor: 13.506
Authors: Antje Fahrig; T Koch; M Lenhart; P Rieckmann; R Fietkau; Luitpold Distel; B Schuster Journal: Strahlenther Onkol Date: 2017-09-08 Impact factor: 3.621
Authors: Benjamin A Toll; Thomas H Brandon; Ellen R Gritz; Graham W Warren; Roy S Herbst Journal: Clin Cancer Res Date: 2013-04-09 Impact factor: 12.531
Authors: Jae Heon Kim; Sung Ryul Shim; Yash Khandwala; Francesco Del Giudice; Simon Sorensen; Benjamin I Chung Journal: World J Mens Health Date: 2019-05-23 Impact factor: 5.400