Medical Versus Minimally Invasive Therapy for BPH

BPH 的药物治疗与微创治疗

• 批准号: 6944703
• 负责人: Kevin M Slawin
• 金额: --
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6944703
• 关键词: alpha antiadrenergic agent; benign prostate hyperplasia; clinical trials; combination therapy; cooperative study; human subject; human therapy evaluation; hyperthermia therapy; male; microwave radiation; patient oriented research; reproductive system disorder chemotherapy

DESCRIPTION (provided by applicant): Through this application, Baylor College of Medicine responds to RFA: DK-O1-024, Minimally Invasive Surgical Therapies (MIST) Treatment Consortium for BPH. 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, and minority health issues, the Baylor Prostate Center proposes to serve as a Prostate Evaluation and Treatment Center (PETC) within the MIST consortium which will work cooperatively with the other PEWS, the BCC, and the NIDDK Project Coordinator to design and conduct randomized, controlled clinical trials of the long-term efficacy and safety of the major "minimally invasive" approaches for the treatment of symptomatic BPH. Drawing from a population of almost 3,000 men over the age of 50 with an AUA symptom score > 15 and not previously treated for BPH, the Baylor PETC pledges with reasonable assurance to randomize up to 200 patients, including a minimum of 10 percent minority participation, on an agreed upon clinical trials protocols over a 3-year recruitment phase due to the unique resources committed to the successful outcome of this trial. The Baylor PETC will build on the considerable experience and expertise gained from the MTOPS Trial, including expertise in study design, large-scale patient recruitment, patient retention and maintenance on study protocols, transrectal ultrasound and biopsy of the prostate, and cooperative study performance to help ensure the success of this Consortium. Furthermore, the experience gained by the Baylor Prostate Center?s participation as a SPORE in Prostate Cancer will further support our PETC. Through the efforts of this RFA proposal, the Baylor Prostate Evaluation and Treatment Center, along with the other centers and the NIDDK, hopes to answer important questions regarding the respective roles of medical therapy and minimally invasive surgical therapy in the treatment of patients with BPH, the identification of the most efficacious, durable, and cost-effective minimally invasive modalities, and to gain insight into the clinical, pathological, and molecular correlates that determine response to these therapies.

描述（由申请人提供）： 通过此申请，贝勒医学院对 RFA 做出回应： DK-O1-024，微创手术疗法 (MIST) 治疗联盟 对于前列腺增生症。在具有广泛兴趣的调查员的领导下 包括BPH和前列腺癌的临床和基础研究、临床 试验招募和管理以及少数族裔健康问题，贝勒 前列腺中心拟作为前列腺评估和治疗中心 (PETC) 在 MIST 联盟内，将与其他联盟合作 PEWS、BCC 和 NIDDK 项目协调员设计和实施 长期疗效和安全性的随机对照临床试验 治疗症状性 BPH 的主要“微创”方法。 从近 3,000 名 50 岁以上持有 AUA 的男性中抽取 贝勒 PETC 承诺症状评分 > 15 并且之前未接受过 BPH 治疗 有合理保证随机分配最多 200 名患者，包括最少 10% 少数族裔参与，在商定的临床试验中 由于承诺的独特资源，招聘阶段为期 3 年 以确保本次试验取得圆满成功。贝勒 PETC 将建立在 从 MTOPS 试验中获得的丰富经验和专业知识，包括 研究设计、大规模患者招募、患者保留方面的专业知识 以及研究方案、经直肠超声和活检的维护 前列腺和合作研究表现有助于确保这项研究的成功 财团。此外，贝勒前列腺中心获得的经验 作为 SPORE 参与前列腺癌将进一步支持我们的 PETC。 通过这项 RFA 提案的努力，贝勒前列腺评估和 治疗中心以及其他中心和 NIDDK 希望能够给出答案 关于药物治疗各自作用的重要问题和 微创手术治疗BPH患者的疗效 确定最有效、最持久、最具成本效益的最低限度 侵入方式，并深入了解临床、病理和 决定对这些疗法的反应的分子相关性。