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Profile of Men Randomized to the Prostate Cancer Prevention Trial: Baseline Health-Related Quality of Life, Urinary and Sexual Functioning, and Health Behaviors

From the Southwest Oncology Group Statistical Center, Division of Public Health Sciences, and Clinical Division, Fred Hutchinson Cancer Research Center, Seattle, WA; Department of Surgery, Brooke Army Medical Center, and Southwest Oncology Group, Operations Office, San Antonio, TX; QualityMetric, Lincoln, RI; New England Medical Center, Boston, MA; Schools of Medicine and Public Health and Jonsson Comprehensive Cancer Center, University of California at Los Angeles, Los Angeles, CA; Department of Health Services, University of Washington, Seattle, WA; and Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC.

Address correspondence to Carol M. Moinpour, PhD, Southwest Oncology Group Statistical Center/MP557, 1100 Fairview Ave North, Box 19024, Seattle, WA 98109-1024; email carolm{at}swog.fhcrc.org

PURPOSE: To describe men who agreed to be randomized to the Prostate Cancer Prevention Trial (PCPT), a 7-year, double-blind placebo-controlled study of the efficacy of finasteride in preventing prostate cancer.

METHODS: Comprehensive health-related quality-of-life data are presented for 18,882 randomized PCPT participants.

RESULTS: PCPT participants are highly educated, middle to upper income, and primarily white (92%). Participants reported healthy lifestyles. The mean American Urological Association Symptom Index score was well below the maximum entry score of less than 19; existing urinary symptoms were generally not bothersome. The scores for two sexual functioning scales could range from 0 to 100, with higher scores reflecting worse sexual functioning. The mean score for the Sexual Problem Scale was 19.2 out of 100, and the mean Sexual Activities Scale was 44.1 out of 100. Scores for seven of the eight Medical Outcomes Study 36-item Short-Form Health Survey scales (higher scores are better) were 10 to 20 points higher than those reported by a general population sample and differed minimally by race but not by age. Previously reported associations between sexual dysfunction and hypertension, diabetes, and depression were also observed. Men who never smoked reported less sexual dysfunction than did those who either had quit or still smoked.

CONCLUSION: Individuals who are likely to enroll in primary prevention trials have a high socioeconomic status, healthy lifestyle behaviors, and better health than the general population. These data help oncologists design chemoprevention trials with respect to the selection of health-related quality-of-life assessments and recruitment strategies.

Funding for active drug and placebo and small grants for recruitment and adherence activities provided by Merck & Company.

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