Medical Versus Minimally Invasive Therapy for BPH

BPH 的药物治疗与微创治疗

• 批准号: 6659812
• 负责人: Kevin M Slawin
• 金额: $ 30.44万
• 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 2006-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6659812
• 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）： 通过这个应用程序，贝勒医学院回应RFA： DK-O 1 -024，微创外科治疗（MIST）治疗联盟 前列腺增生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 审判招募和管理，少数民族健康问题，贝勒 前列腺中心建议作为前列腺评估和治疗中心 （PETC）在MIST联盟内，将与其他 PEWS、BCC和NIDDK项目协调员设计和执行 长期有效性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名年龄在50岁以上的AUA男性中抽取 症状评分> 15，以前没有接受过BPH治疗，Baylor PETC承诺 有合理的保证随机化多达200名患者，包括最少 10%的少数民族参与，在商定的临床试验， 由于承诺的独特资源，协议需要3年的招聘阶段 这场审判的成功贝勒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 和维持研究方案，经直肠超声和活检的 前列腺，和合作研究的表现，以帮助确保这一成功 财团此外，贝勒前列腺中心获得的经验？S 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，沿着与其他中心和NIDDK，希望回答 关于药物治疗各自作用的重要问题， 微创手术治疗BPH患者， 确定最有效、最持久和最具成本效益的 侵入性方式，并深入了解临床，病理， 决定对这些疗法的反应的分子相关物。