The Efficacy of TUMT and Neoadjuvant Finasteride for BPH

描述(由申请人提供)： 良性前列腺增生症(BPH)是最常见的肿瘤。 并构成影响男性健康的一个主要因素 美国男性。微创外科治疗的目标 (MIST)良性前列腺增生症联盟是设计和进行最多几个随机、 多中心对照临床试验，以确定长期疗效和 症状性前列腺增生症的微创治疗的安全性包括 经尿路微波热疗(TUMT)。TUMT的潜在优势 包括通过使用最小麻醉的办公室内程序缓解LUT 并迅速恢复。TUMT已被热情地应用于患有 BPH，但报告缺乏统一的结果衡量标准，几乎没有 关于手术后药物治疗的数据。其中一项目标是 RFA是为了评估辅助药物治疗是否改善了长期 雾的结局。在这种情况下，我们假设非那雄胺可以增加 TUMT治疗中前列腺组织坏死的诱因 转化生长因子-β介导的细胞凋亡。我们认为非那雄胺的这种已知作用 在TUMT的新佐剂环境中使用时，将增加“热杀灭” 并带来更好的结果。 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，以解决是否有细胞凋亡效应 新佐剂和非那雄胺佐剂联合热效应 TUMT协同作用破坏更多的BPH肿块并改善预后 或单用非那雄胺或单用TUMT。我们提出了一种三臂安慰剂/假肢 以症状变化为主要指标的随机对照临床试验

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