Benign prostate hyperplasia: thermotherapy/finasteride

良性前列腺增生：热疗/非那雄胺

• 批准号: 6439363
• 负责人: KEVIN T. MCVARY
• 金额: $ 10万
• 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 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6439363
• 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）是最常见的肿瘤性疾病 是影响男性健康的重要因素 美国男。微创手术治疗的目标 (MIST) BPH 联盟将设计并进行最多几个随机、 对照、多中心临床试验以确定长期疗效和 有症状 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 包括通过使用最低限度麻醉的诊室手术来缓解 LUTS 并迅速康复。 TUMT 已被广泛应用于患有以下疾病的患者 BPH，但报告缺乏统一的结果测量，而且很少 术后药物治疗的数据。中提出的目标之一 RFA旨在评估辅助药物治疗是否可以改善长期症状 MIST 的结果。有鉴于此，我们假设非那雄胺可以增强 TUMT 能够诱导前列腺组织坏死 TGF-β介导的细胞凋亡。我们建议非那雄胺的这种已知作用 当与 TUMT 一起用于新辅助治疗时，会增加“热杀伤” 并带来更好的结果。 这是一个真正令人兴奋的研究方向，具有巨大的潜力 对患者和医疗保健提供系统都有影响。我们 提出一项初步临床试验来解决是否有细胞凋亡作用 新辅助剂和辅助剂非那雄胺结合热效应 TUMT 协同作用，可破坏更多的 BPH 质量并改善结果 单独使用非那雄胺或单独使用 TUMT。我们提议使用 3 组安慰剂/假手术 使用症状变化作为主要指标的对照、随机临床试验