Under the leadership of investigators with a wide range of interests including clinical and basic research in BPH and prostate cancer, clinical trials recruitment and management, minority health issues, and geriatric medicine, Baylor proposes to establish a Clinical Center which will work cooperatively with the other clinical centers participating in this clinical trial, the data coordinating center, the diagnostic center, and the NIDDK Project Coordinator to develop and implement a full scale, common protocol for subject recruitment and screening, medical therapy intervention, patient monitoring and follow-up, and data and specimen collection and management. Drawing from a potential recruitment population of over 7200 men over the age of 50 with an AUA symptom score equal to or greater than 8, the Baylor Clinical Center pledges with reasonable assurance to randomize 200 patients on this clinical trial within a 24 month period, and follow them for a period of up to six years. The Baylor Clinical Center offers a unique opportunity to recruit a significant number of minority and geriatric subjects to this trial due to the unique resources committed to its execution. Our center also has significant resources committed to a care of young investigators who are poised to propose and carry out novel basic research studies into the pathogenesis and therapy of BPH as an adjunct to this clinical trial. Though maintaining a separate organizational structure and budget, the Baylor Clinical Center will draw from the significant experience and expertise in the areas of large scale patient data management, information systems, and tissue and serum banking acquired as a consequence of the Baylor SPORE in prostate cancer. Through the efforts of this RFA proposal, the Baylor Clinical Center along with the other centers and the NIDDK hopes to answer important questions regarding the ability of medical therapy to impact on the progression of BPH and to gain insights into the clinical, pathological, and molecular correlates to disease response and progression.
