Minimally Invasive Surgical Therapies Consortium for BPH

描述(由申请人提供)： 乔治华盛顿大学生物统计中心建议在 与美国国家糖尿病和消化研究所的合作协议 和肾脏疾病(NIDDK)担任生物统计协调中心 (BCC)微创外科治疗(MIST)联盟 良性前列腺增生症(BPH)最小标签的前列腺手术 侵入性提供了黄金标准的令人兴奋的治疗替代方案， 经尿道前列腺电切术(TURP)。拟议中的财团--S 目标是设计和实施最多四个随机、对照、 多中心临床试验以确定阿司匹林的长期疗效和安全性 症状性良性前列腺增生症的微创治疗 (BPH)。来自15个前列腺评估和治疗的研究人员和研究人员 NIDDK肾脏、泌尿外科和血液科中心(PETC) 疾病，而BCC将组成该财团并在 合作协议机制。 指导和规划委员会，由主要调查员组成 来自BCC和每个PETS和NIDDK项目官员，将设计和 开展每一项临床试验。BCC将提供集中支持 和生物统计学咨询：制定方案，手册 程序、数据收集表格和随机化程序；实施 包括数据质量评估的数据管理系统.中期分析 方案性能、患者安全性和治疗效果；以及最终 与临床医学合作发表成果的分析 调查人员。密件抄送将建立安全的加密和密码保护 为学习人员提供的网站，以加强学习的开发、分发和使用 文件。 该应用程序包括一项建议的三臂安慰剂/假手术方案 对照、随机、双盲临床试验，以解决 新佐剂与非那雄胺联合应用对细胞凋亡的影响 高能经尿道微波热疗的热效应 协同行动，摧毁更多的BPH肿块并改善结果 单用非那雄胺或单用TUMT。成功的定义是至少30% AUA症状评分的改善。

DESCRIPTION (provided by applicant): The George Washington University Biostatistics Center proposes to work in cooperative agreement with the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) to serve as the Biostatistical Coordinating Center (BCC) for the Minimally Invasive Surgical Therapies (MIST) Consortium for Benign Prostatic Hyperplasia (BPH). The prostate surgeries labeled minimally invasive offer exciting treatment alternatives to the gold standard, transurethral resection of the prostate (TURP). The proposed consortium?s objective is to design and conduct up to four randomized, controlled, multi-center clinical trials to determine the long-term efficacy and safety of minimally invasive therapies for symptomatic benign prostatic hyperplasia (BPH). Researchers and investigators from 15 prostate evaluation and treatment centers (PETC), the NIDDK Division of Kidney, Urologic, and Hematologic Diseases, and the BCC will comprise the consortium and collaborate under a cooperative agreement mechanism. The Steering and Planning Committee, composed of the principal investigators from the BCC and each PETC and the NIDDK project officer, will design and develop each of the clinical trials. The BCC will provide centralized support and biostatistical consultation in: the development of protocols, manuals of procedures, data collection forms, and randomization procedures; implementation of a data management system including data quality assessment; interim analysis of protocol performance, patient safety, and treatment efficacy; and final analysis for publication of results in collaboration with the clinical investigators. The BCC will establish a secure encrypted and password protected web site for study staff to enhance development, distribution, and use of study documents. The application includes a proposed protocol for a 3-arm, placebo/sham controlled, randomized, double-blind clinical trial to address whether the apoptotic effect of neoadjuvant and adjuvant finasteride in combination with the thermal effect of high-energy transurethral microwave thermotherapy (TUMT) act synergistically to destroy more BPH mass and improve outcome than either finasteride alone or TUMT alone. Success is defined as at least 30 percent improvement in AUA symptom score.