MEDICAL THERAPY FOR BPH--DATA COORDINATING CENTER

乔治华盛顿大学生物统计中心建议 与美国国家糖尿病研究所达成合作协议 以及消化和肾脏疾病(NIDDK-NIH)作为数据 建议的多中心临床试验的协调中心(DCC) 良性前列腺增生症的内科治疗。其目的是 NIH-BPH临床试验的目的是确定该药的安全性和有效性 非那雄胺(5-α-还原酶抑制剂)和 多沙唑嗪(一种α-1肾上腺素受体阻滞剂)的临床应用 良性前列腺增生症的进展。 过渡阶段的目标是敲定议定书， 操作手册和数据收集表格将在6年内实施 全面临床试验。这项试验将需要2800人的随机分组 17名临床诊断为2年以上良性前列腺增生症的参与者 中锋。符合条件的参与者将被随机分配，双重掩饰， 四个治疗组之一：(1)活性非那雄胺(5毫克，每次1次) 和活性多沙唑嗪(4毫克或8毫克，每天一次)；(2)活性 非那雄胺和多沙唑嗪安慰剂；(3)非那雄胺安慰剂和活性 多沙唑嗪；或(4)非那雄胺安慰剂和多沙唑嗪安慰剂。随机化 参与者将被跟踪最少4年(最多6年 数年)，每季度进行一次后续访问。良性前列腺增生症的临床进展 定义为急性尿潴留、肾功能不全、 反复的尿路感染、大小便失禁或预先指定的 美国泌尿系协会(AUA)症状评分增加。 次要结果包括四种治疗方法随时间的差异。 AUA症状评分、生活质量和最高生活质量 尿流。组织活检将在20%的 参加者提供有关良性前列腺增生症的组织病理学及 检测现有生物标记物的预后能力 对药物治疗的反应。 DCC的具体目标是提供集中支持和 先导研究过渡中的生物统计学咨询 患者管理规程、操作手册、数据采集表 和随机化程序进行全面的临床试验； 一种包含数据质量的数据处理系统的实现 评估；协议性能、患者安全和 治疗效果；美国国立卫生研究院-前列腺增生症出版的最终分析 临床试验结果与临床研究人员合作。

The Biostatistics Center of The George Washington University proposes to work in cooperative agreement with the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK-NIH) to serve as the Data Coordinating Center (DCC) for a proposed multi-center clinical trial of the medical therapy of benign prostatic hyperplasia (BPH). the purpose of the NIH-BPH Clinical Trial is to determine the safety and efficacy of the pharmacotherapies finasteride (an inhibitor of 5-alpha-reductase) and doxazosin (a blocker of alpha-1 adrenoreceptors) on the clinical progression of BPH. The objective of the transition phase is to finalize the protocol, operations manual and data collection forms to be implemented in a 6 year full-scale clinical trial. The trial will require randomization of 2,800 participants with a diagnosis of BPH over a 2 year period in 17 clinical centers. Eligible participants will be randomly assigned, double-masked, to one of four treatment groups: (1) active finasteride (5 mg., once per day) and active doxazosin (4 mg or 8 mg, once per day); (2) active finasteride and doxazosin placebo; (3) finasteride placebo and active doxazosin; or (4) finasteride placebo and doxazosin placebo. Randomized participants will be followed for a minimum of 4 years (maximum of 6 years) with quarterly follow-up visits. Clinical progression of BPH is defined by the incidence of acute urinary retention, renal insufficiency, recurrent urinary tract infections, incontinence, or a pre-specified increase in the American Urological Association (AUA) symptom score. Secondary outcomes include differences over time among the four treatment groups with respect to AUA symptom score Quality of Life and maximal uroflow. Tissue biopsies will be obtained in 20 percent of the participants to provide information on the histopathobiology of BPH and to test existing biomarkers for their prognostic ability regarding response to medical therapy. The specific aims of the DCC are to provide centralized support and biostatistical consultation in the transition of the pilot study's patient management protocols, operations manual, data collection forms and randomization procedures to the full-scale clinical trial; implementation of a data processing system including data quality assessment; interim analysis of protocol performance, patient safety and treatment efficacy; ad final analysis for publication of the NIH-BPH Clinical Trial results in collaboration with the clinical investigators.