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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK049954-05
Application #
2900300
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Kusek, John W
Project Start
1995-04-27
Project End
2002-03-31
Budget Start
1999-07-15
Budget End
2000-03-31
Support Year
5
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Washington University
Department
Surgery
Type
Schools of Medicine
DUNS #
062761671
City
Saint Louis
State
MO
Country
United States
Zip Code
63130
Kaplan, Steven A; Lee, Jeannette Y; O'Neill, Edward A et al. (2013) Prevalence of low testosterone and its relationship to body mass index in older men with lower urinary tract symptoms associated with benign prostatic hyperplasia. Aging Male 16:169-72
Kaplan, Steven A; Lee, Jeannette Y; Meehan, Alan G et al. (2011) Long-term treatment with finasteride improves clinical progression of benign prostatic hyperplasia in men with an enlarged versus a smaller prostate: data from the MTOPS trial. J Urol 185:1369-73
Kaplan, Steven A; Roehrborn, Claus G; McConnell, John D et al. (2008) Long-term treatment with finasteride results in a clinically significant reduction in total prostate volume compared to placebo over the full range of baseline prostate sizes in men enrolled in the MTOPS trial. J Urol 180:1030-2;discussion 1032-3
Johnson 2nd, Theodore M; Burrows, Pamela K; Kusek, John W et al. (2007) The effect of doxazosin, finasteride and combination therapy on nocturia in men with benign prostatic hyperplasia. J Urol 178:2045-50;discussion 2050-1
Crawford, E David; Wilson, Shandra S; McConnell, John D et al. (2006) Baseline factors as predictors of clinical progression of benign prostatic hyperplasia in men treated with placebo. J Urol 175:1422-6; discussion 1426-7
Kaplan, Steven A; McConnell, John D; Roehrborn, Claus G et al. (2006) Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater. J Urol 175:217-20; discussion 220-1
McConnell, John D; Roehrborn, Claus G; Bautista, Oliver M et al. (2003) The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med 349:2387-98