Journal of the National Cancer Institute Advance Access published online on June 27, 2007
JNCI Journal of the National Cancer Institute, doi:10.1093/jnci/djm023
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© The Author 2007. Published by Oxford University Press.
ARTICLES |
Longitudinal Analysis of Sexual Function Reported by Men in the Prostate Cancer Prevention Trial
Affiliations of authors: Southwest Oncology Group Statistical Center (CMM, AKD) and Division of Public Health Sciences (DLP), Fred Hutchinson Cancer Research Center, Seattle, WA; Pain Research Center, Department of Anesthesiology, University of Utah, Salt Lake City, UT (GWD); Department of Urology, University of Texas Health Sciences Center at San Antonio, San Antonio, TX (IMT); Department of Urology, Wilford Hall Medical Center, Lackland Air Force Base, TX (CL); Institute for Medical Informatics, Biometry and Epidemiology, University of Munich, Munich, Germany (DPA); Department of Health Services, University of Washington, Seattle, WA (DLP); QualityMetric Incorporated, Lincoln, RI (JEW); Health Assessment Lab, Waltham, MA (JEW); Schools of Medicine and Public Health and Jonsson Comprehensive Cancer Center, University of California at Los Angeles, CA (PAG); Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC (SAS); Departments of Clinical Cancer Prevention and Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX (SML); Cancer Control and Prevention, Southwest Oncology Group, Operations Office, San Antonio, TX (CAC)
Correspondence to: Carol M. Moinpour, PhD, Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center/M3-C102, 1100 Fairview Ave North, Box 19024, Seattle, WA 98109-1024 (e-mail: cmoinpou{at}fhcrc.org).
Background: The Prostate Cancer Prevention Trial (PCPT) was a randomized, double-blind, placebo-controlled study of the efficacy of finasteride in preventing prostate cancer in 18882 men aged 55 years or older. The PCPT offered an opportunity to prospectively study the effects of finasteride and other covariates on sexual dysfunction.
Methods: We assessed sexual dysfunction in 17313 PCPT participants during a 7-year period. A battery of questionnaires assessed sexual dysfunction (Sexual Activity Scale score); age; race; SF-36 Mental Health Inventory-5, Physical Function, and Vitality scores; body mass index; smoking status; and the presence of diabetes and hypertension. Assessments began at month 6 after random assignment and included the Sexual Activity Scale score at randomization as a covariate. Two-sided general t tests, with a cutoff of P value less than .05, were used to determine the statistical significance for mixed model effects with correlated random time slopes and intercepts. The changing impact of covariates on sexual dysfunction was also assessed at 6 months, 3.5 years, and 6.5 years after randomization.
Results: Finasteride increased sexual dysfunction only slightly and its impact diminished over time; the increase in the Sexual Activity Scale score relative to placebo of 3.21 points (95% confidence interval [CI] = 2.83 to 3.59 points; P<.001) at the first assessment decreased to 2.11 points (95% CI = 1.44 to 2.81 points; P<.001) at the end of study. These Sexual Activity score values were small on a scale of 0–100, the range observed in the study, and in comparison with individual variation. After adjustment for all covariates, mean sexual dysfunction increased in both arms from baseline (6 months after randomization) by 1.26 Sexual Activity points (95% CI = 1.16 to 1.36 points; P<.001) per year, corresponding to a cumulative increase of 8.22 points (95% CI = 7.52 to 8.92 points; P<.001) over the study period.
Conclusions: The effect of finasteride on sexual functioning is minimal for most men and should not impact the decision to prescribe or take finasteride.
| CONTEXT AND CAVEATS Prior knowledge
The use of the 5 Study design PCTP participants completed questionnaires regularly throughout the 7 years of the study to quantify the effects of finasteride and other factors (e.g., age, medical conditions, smoking status) on sexual dysfunction over time. Contribution Finasteride caused a small average increase in sexual dysfunction that decreased over time. The effects of finasteride treatment on sexual dysfunction were clinically less relevant than natural sources of variability in the study population. Implications Finasteride would cause little or no sexual dysfunction for most men who might take it. Limitations Patient-reported outcomes were not collected from participants who temporarily or permanently discontinued taking the assigned study drug, and sexual dysfunction side effects were often cited as the reason for discontinuing. The scale used to measure sexual dysfunction was not an established psychometric measure before its use in the PCPT.
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-reductase inhibitor finasteride has been linked to sexual dysfunction in men. However, results from previous studies including the Prostate Cancer Prevention Trial (PCPT) have suggested that evaluations of the impact of finasteride on sexual dysfunction must take into account the amount of time on study and participant age, as well as individual variation among men.Manuscript received December 1, 2006; revised April 27, 2007; accepted May 22, 2007.
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J Natl Cancer Inst 2007 99: 981.
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