MEDICAL THERAPY IN BENIGN PROSTATIC HYPERPLASIA

良性前列腺增生的药物治疗

• 批准号: 2391506
• 负责人: Kevin M Slawin
• 金额: $ 45.29万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-04-27 至 2002-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2391506
• 关键词: alpha antiadrenergic agent; benign prostate hyperplasia; clinical trials; cooperative study; enzyme inhibitors; human subject; human therapy evaluation; male; reproductive system disorder chemotherapy

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.

在具有广泛利益的调查人员的领导下 包括前列腺增生症和前列腺癌的临床和基础研究 试验招募和管理、少数民族健康问题和老年病 医学，贝勒建议建立一个临床中心，将工作 与参与此次活动的其他临床中心合作 临床试验、数据协调中心、诊断中心和 NIDDK项目协调员制定和实施全面的、 受试者招募和筛选、医学治疗的通用方案 干预、患者监测和随访，以及数据和样本 收集和管理。从潜在的招聘人群中抽取 在超过7200名50岁以上的男性中，AUA症状评分等于或等于 大于8，贝勒临床中心承诺以合理的 保证在24小时内随机选择200名患者参加这项临床试验 一个月的期限，并遵循它们长达六年的时间。贝勒酒店 临床中心提供了一个独特的机会来招聘重要的 少数族裔和老年受试者的数量由于独特的 致力于其执行的资源。我们中心也有重要的 致力于照顾年轻调查人员的资源 提出并开展新的发病机制基础研究 以及BPH的治疗作为这项临床试验的辅助手段。尽管 保持单独的组织结构和预算，贝勒 临床中心将借鉴以下方面的重要经验和专业知识 大规模患者数据管理、信息系统和 因贝勒孢子而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 临床中心与其他中心和NIDDK希望回答 关于药物治疗能力影响的重要问题 前列腺增生症的进展和对临床的洞察， 病理和分子与疾病反应和 进步。