Medical Versus Minimally Invasive Therapy for BPH

BPH 的药物治疗与微创治疗

• 批准号: 6524646
• 负责人: Kevin M Slawin
• 金额: $ 31.94万
• 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/6524646
• 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）： 通过此应用，贝勒医学院对RFA做出了回应： DK-O1-024，微创手术疗法（雾）治疗联盟 对于BPH。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 试验招聘和管理以及少数民族健康问题，贝勒 前列腺中心建议用作前列腺评估和治疗中心 （PETC）在薄雾财团内将与另一个合作合作 Pews，BCC和NIDDK项目协调员设计和进行 长期疗效和安全性的随机对照临床试验 症状BPH治疗的主要“微创”方法。 从50岁以上的近3,000名男性中吸引 症状评分> 15，以前未接受BPH治疗，Baylor PETC承诺 合理的保证可以随机多达200名患者，包括最低 在商定的临床试验中，有10％的少数族裔参与 由于所做的独特资源，在3年招聘阶段的协议 为了成功的结果。 Baylor PETC将建立在 MTOPS试验获得的丰富经验和专业知识，包括 研究设计方面的专业知识，大规模的患者招聘，患者保留 并维持研究方案，超声超声和活检 前列腺和合作研究表现，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 作为孢子的前列腺癌参与将进一步支持我们的PETC。 通过该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希望回答 有关医疗疗法和各自作用的重要问题 在BPH患者治疗中，微创手术治疗 识别最有效，耐用且具有成本效益的最低限度 侵入性方式，并深入了解临床，病理和 分子相关，确定对这些疗法的反应。