This Clinical Center will recruit at least 200 appropriate participants for this study over the 24 month period of recruitment. Patients for this study will be solicited by direct mail with an """"""""eligibility screener"""""""" from an """"""""enriched"""""""" list of approximately 10,000 men known to have symptoms of BPH and/or to be interested in participating in clinical trials. This """"""""enriched"""""""" list is derived from 3 general sources: men who have completed a prostate cancer screening study, those who have been ineligible but interested in prior prostatic studies performed at our center, and untreated patients with BPH who are followed by faculty members of the Division of Urologic Surgery with the diagnosis of BPH. If other sources of patients for this trial are necessary, they will be derived by referrals from the BJC Network of 2,000 primary care physicians in the St. Louis Metropolitan area and through appropriate media announcements. This study will be performed at the Prostate Study Center at Barnes West County Hospital. The Prostate Study Center is a fully staffed suite devoted to clinical investigation. It is located in the suburbs, near the population center of the St. Louis Metropolitan area. There is a complete infra-structure of appropriate space, personnel, and equipment for performance of this trial. Eighteen collaborative multi-center placebo- controlled trials have been completed or are ongoing at this site. The Principal Investigator has considerable experience with multi- institutional, prospective trials; the Division of Urologic Surgery at Washington University School of Medicine, and Barnes West County Hospital will provide the appropriate intellectual background and support for this study. This Clinical Center will be a significant contributor to completion of all aspects of the trial: recruitment, protocol refinement, and development, evaluation and performance of potential correlative science investigations.
