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提议在 与美国国立糖尿病和消化研究所的合作协议 和肾脏疾病（NIDDK）作为生物统计协调中心 (BCC)微创外科治疗（MIST）联盟 良性前列腺增生（BPH）。前列腺手术标记为最小 侵入性提供了令人兴奋的治疗替代金标准， 经尿道前列腺切除术（TURP）。拟议中的财团？S 目的是设计并进行多达四个随机，对照， 多中心临床试验，以确定长期疗效和安全性 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调查人员 NIDDK肾脏、泌尿和血液科分部 疾病，BCC将组成该财团，并在一个 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PETC以及NIDDK项目官员的设计和 开展每一项临床试验。BCC将提供集中支持 和生物统计咨询：制定协议，手册， 程序、数据收集表和随机化程序;实施 数据管理系统，包括数据质量评估;中期分析 方案性能、患者安全性和治疗有效性;以及最终 与临床研究机构合作分析结果以供发表 investigators. BCC将建立一个安全的加密和密码保护 研究人员网站，以加强研究的开发，分发和使用 证件 该申请包括3组安慰剂/假手术的拟定方案 对照，随机，双盲临床试验，以解决是否 新辅助剂和辅助芬鲁肽联合的凋亡作用 高能经尿道微波热疗的热效应 协同作用，比任何一种都能摧毁更多的前列腺增生肿块并改善结果 单独使用financial de或TUMT。成功被定义为至少30% AUA症状评分改善。

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.