Profile of men randomized to the prostate cancer prevention trial: Baseline health-related quality of life, urinary and sexual functioning, and health behaviors

Purpose: To describe men who agreed ta be randomized ta the Prostate Cancer Prevention Trial (PCPT), a 7-year, double-blind placebo-controlled study o f the efficacy of finasteride in preventing prostate cancer. Methods: Comprehensive health-related quality-of-life data are presented fo r 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 maxi mum entry score of less than 19; existing urinary symptoms were generally n ot bothersome. The scores for two sexual functioning scales could range fro m 0 to 100, with higher scores reflecting worse sexual functioning. The mea n score for the Sexual Problem Scale was 19.2 aut of 100, and the mean Sexu al Activities Scale wets 44.1 out of 100. Scores for seven of the eight Med ical 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 po pulation sample and differed minimally by race but not by age. Previously r eported associations between sexual dysfunction and hypertension, diabetes, and depression were also observed. Men who never smoked reported less sexu al dysfunction than did those who either had quit or still smoked. Conclusion: Individuals who are likely to enroll in primary prevention tria ls have a high socioeconomic status, healthy lifestyle behaviors, and bette r health than the general population. These data help oncologists design ch emoprevention trials with respect to the selection of health-related qualit y-of-life assessments and recruitment strategies. (C) 2000 by American Soci ety of Clinical Oncology.