The Efficacy of TUMT and Neoadjuvant Finasteride for BPH

TUMT 和新辅助非那雄胺治疗 BPH 的疗效

• 批准号: 6942456
• 负责人: KEVIN T. MCVARY
• 金额: --
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 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/6942456
• 关键词: adult human (21+); apoptosis; benign prostate hyperplasia; blood tests; clinical trials; combination therapy; cooperative study; disease /disorder prevention /control; finasteride; human subject; human therapy evaluation; hyperthermia therapy; longitudinal human study; male; microwave radiation; outcomes research; patient oriented research; physical chemical interaction; reproductive system disorder chemotherapy; statistics /biometry; transforming growth factors; ultrasound; urinary catheterization

DESCRIPTION (provided by applicant): Benign prostatic hyperplasia (BPH) is the most common neoplastic condition afflicting men and constitutes a major factor impacting the health of the American male. The objective of the Minimally Invasive Surgical Therapies (MIST) Consortium for BPH is to design and conduct up to several randomized, controlled, multicenter clinical trials to determine the long-term efficacy and safety of minimally invasive therapies for symptomatic BPH including Transurethral Microwave Thermotherapy (TUMT). The potential advantages of TUMT include the relief of LUTS with an in-office procedure using minimal anesthesia and a rapid recovery. TUMT has been enthusiastically applied to patients with BPH, but reports suffer from lack of uniform outcome measurements and little data on post-surgical pharmacological treatment. One of the goals stated in the RFA is to assess whether adjuvant medical therapy improves the long-term outcome of MIST. In this light, we hypothesize that finasteride can augment the necrosis of prostatic tissue undergoing TUMT by virtue of it ability to induce TGF-beta mediated apoptosis. We propose that this known effect of finasteride will increase the "thermal kill" when used in a neoadjuvant setting with TUMT and result in an improved outcome. This is a truly exciting research direction, with considerable potential ramifications for both the patient and the health care delivery system. We propose an initial clinical trial to address whether the apoptotic effect of neoadjuvant and adjuvant finasteride in combination with the thermal effect of TUMT act synergistically to destroy more BPH mass and improve outcome than either finasteride alone or TUMT alone. We are proposing a 3-arm, placebo/sham controlled, randomized clinical trial using changes in symptoms as the primary

描述（由申请人提供）： 良性前列腺增生（BPH）是最常见的肿瘤条件 影响男性健康的主要因素， 美国男性微创外科治疗的目的 （MIST）BPH联盟将设计和进行多个随机， 对照、多中心临床试验，以确定长期疗效， 症状性BPH微创治疗的安全性，包括 经尿道微波热疗（TUMT）。TUMT的潜在优势 包括通过使用最小麻醉的诊室手术缓解LUTS 并迅速恢复。TUMT已被热情地应用于患者， BPH，但报告缺乏统一的结果测量， 术后药物治疗数据。《世界人权宣言》所述的目标之一， RFA是为了评估辅助药物治疗是否改善了长期 的结果。在这种情况下，我们假设，financede可以增加 由于其诱导前列腺组织坏死的能力， TGF-β介导的细胞凋亡。我们认为，这种已知的影响financede 当在TUMT的新辅助治疗环境中使用时， 并导致改善的结果。 这是一个真正令人兴奋的研究方向，具有相当大的潜力 对患者和医疗保健提供系统的影响。我们 提出一项初步的临床试验，以解决是否凋亡的影响， 新辅助治疗和辅助治疗芬那肽联合热效应 TUMT协同作用，破坏更多的BPH质量，改善结果， 或者单独使用finaldade或者单独使用TUMT。我们提出了一个3组，安慰剂/假手术 以症状变化为主要指标的对照、随机临床试验

项目成果

Impact of phytotherapy on utility scores for 5 benign prostatic hyperplasia/lower urinary tract symptoms health states.

植物疗法对 5 种良性前列腺增生/下尿路症状健康状况效用评分的影响。

• DOI: 10.1016/j.juro.2007.08.152
• 发表时间: 2008
• 期刊: The Journal of urology
• 作者: Dedhia,RajC;Calhoun,Elizabeth;McVary,KevinT
• 通讯作者: McVary,KevinT

Variation in institutional review board responses to a standard protocol for a multicenter randomized, controlled surgical trial.

• DOI: 10.1016/j.juro.2009.02.032
• 发表时间: 2009-06
• 期刊: The Journal of urology
• 作者: Helfand BT;Mongiu AK;Roehrborn CG;Donnell RF;Bruskewitz R;Kaplan SA;Kusek JW;Coombs L;McVary KT;MIST Investigators
• 通讯作者: MIST Investigators

Editorial Comment.

编辑评论。

• DOI: 10.1097/ju.0000000000001640.01
• 发表时间: 2021
• 期刊: The Journal of urology
• 作者: Bauer,ScottR;Huang,Alison
• 通讯作者: Huang,Alison