MEDICAL THERAPY IN BENIGN PROSTATIC HYPERPLASIA

在兴趣广泛的调查人员的带领下 包括BPH和前列腺癌的临床和基础研究，临床 试验招募和管理、少数民族健康问题和老年病 贝勒建议建立一个临床中心， 与其他临床中心合作， 临床试验、数据协调中心、诊断中心，以及 NIDDK项目协调员开发和实施一个全面的， 受试者招募和筛选、药物治疗的通用方案 干预、患者监测和随访以及数据和样本 收集和管理。从潜在的征聘人群中挑选人员 超过7200名50岁以上的男性，AUA症状评分等于或 大于8，贝勒临床中心承诺， 保证在24小时内随机分配200名患者参加本临床试验 一个月的时间，并跟踪他们长达六年的时间。贝勒 临床中心提供了一个独特的机会，招募一个重要的 本试验中少数民族和老年受试者的数量，因为 资源投入执行。我们的中心也有重要的 资源致力于照顾年轻的调查人员谁是准备 提出并开展新的发病机制基础研究 和BPH的治疗作为本临床试验的辅助。虽然 保持一个单独的组织结构和预算，贝勒 临床中心将利用以下方面的丰富经验和专业知识： 大规模患者数据管理、信息系统和 由于Baylor SPORE获得的组织和血清库 前列腺癌通过这项RFA提案的努力，贝勒 临床中心沿着与其他中心和NIDDK希望回答 关于药物治疗影响能力的重要问题 前列腺增生症的进展，并获得对临床的见解， 病理学和分子学与疾病反应相关， 进展

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.