Benign Prostatic Hyperplasia is the most prevalent of all pathologic entities in aging males. It is estimated that almost every man who lives long enough will develop BPH. Nodules of BPH begin to develop as early as the age of 30, with the prevalence of microscopic BPH rising to 100% in men in their eighties. Despite the high prevalence of BPH, there is a striking paucity of studies describing the natural history of this condition. Available studies to date do not conform to appropriate models by which to study the natural history of a disease. An ideal design should assemble cohorts of patients at a uniformly early stage near onset of disease, and follow these cohorts prospectively with a series of standardized evaluations. The proposal is to participate in such a designed study: a collaborative, multi-center randomized trial of medical therapy for BPH. Although there is enough evidence that the available pharmacologic agents can provide a measure of relief to many BPH patients, the exact role of these agents in the overall management of BPH is yet unknown. The main focus is on recruitment of sufficient patients in order to answer the following questions: whether combination therapy of 5-alpha- reductase and alpha-1-blockers is superior to either agent alone, whether there any correlations between histologic features of BPH and outcome measures of treatment, and which medication or combination of medications results in the best outcome measured by confidence interval rates. The research team assembled for this project demonstrates sufficient experience in urologic research and in accrual to BPH clinical trials (including the pilot phase of this study) to accomplish stated objectives of the trial. Clinical facilities that will provide access to suitable patient populations for the trial include public and private institutions: primary care and urology clinics on the Denver and Boulder campuses of the University of Colorado, the Denver and Cheyenne (WY) Veterans Administration Medical Centers, Denver General Hospital, and Kaiser- Permanente Health Plan. Monthly screening for this trial is anticipated at approximately 52 patients, or approximately 625 per year from the clinical facilities described below. Based upon previous experience in the pilot program, as many as 30% (equals approximately 200) of these could be enrolled. However, a likely enrollment midrange between past experience and the national experience (10%) is estimated, anticipating 125-150 patients randomized annually. Special recruitment efforts among the Latino and African-American communities will be instituted. Adherence strategies, critical to the ultimate success and complete evaluation of trial results, include behavioral, social, and educational interventions.
