Continuing Application for the Data Coordinating Center for (CAMUS) Trial (U01)

CAMUS是一项随机、双盲、双组试验，有369名患有良性前列腺增生（BPH）的参与者，在72周的时间内，大约平均分配给Serenoa repens（锯棕榈）提取物或安慰剂，在连续3个24周的时间内，剂量逐渐增加，从每天320毫克开始，然后是640毫克，然后是960毫克。参与者继续接受研究治疗，直到他们符合协议规定的停止治疗的原因或完成72周的治疗期。11个CAMUS临床中心于2008年6月5日开始招募，并于2009年4月17日成功完成369名受试者的随机化。这是一份为CAMUS数据协调中心（DCC）继续提供资金的申请，以确保完成所有参与者的后续工作、数据收集的输入和管理以及结果的准备和出版。此延续应用程序的具体目标是：1。完成CAMUS协议规定的治疗、随访和结束活动2。2 .准备最终的数据集；完成计划的出版物，包括最终结果和基于最终试验数据集的其他论文。在此持续申请期间，DCC在此方面的作用包括：在此资助期内预计的额外8000页等效数据的数据输入；数据编辑、查询生成和最终分析数据集的创建，具有数据字典和缺失数据报告；协调和主持执行委员会、指导委员会、小组委员会和研究协调员会议；编写DSMB和IND报告，分析数据，并为CAMUS准备摘要、手稿和演示文稿。

DESCRIPTION (provided by applicant): CAMUS is a randomized, double-blind, two arm trial with 369 participants with Benign Prostatic Hyperplasia (BPH), approximately equally allocated to either the Serenoa repens (saw palmetto) extract or placebo over a 72 week period in escalating doses over three consecutive 24 weeks periods, beginning with 320 mg, then 640 mg, and then 960 mg daily . Participants continue on study treatment until they meet a protocol defined reason for treatment discontinuation or complete the 72 week treatment period. The 11 CAMUS clinical centers initiated recruitment June 5, 2008 and successfully completed randomization of 369 subjects on April 17, 2009. This is an application for continued funding for the Data Coordinating Center (DCC) for CAMUS to ensure that follow up of all participants, data collection entry and management and preparation and publication of results is completed. Specific Aims for this continuation application are to: 1. Complete CAMUS the protocol-specified treatment, follow-up and close out activities 2. Prepare the final dataset, and 3. Complete planned publications, including final results and other papers based on the final trial dataset The DCC's role in this during the period of this continued application includes, data entry for the additional 8000 page equivalents of data expected in this funding period; data editing, query generation and creation of a final analysis data set with a data dictionary and missing data report; coordination and conduct of Executive Committee, Steering Committee, sub-committee and study coordinator meetings; preparation of DSMB and IND reports and the analysis of data and preparation of abstracts, manuscripts and presentations for CAMUS. PUBLIC HEALTH RELEVANCE: Serenoa Repens (sawpalmetto) is a widely used over the counter agent in the treatment of BPH. So far there is no evidence of its effectiveness in the treatment of BPH. If it is indeed effective at reducing lower urinary tract symptoms, it may well be preferred by many men based on the "natural therapy" appeal, its favorable side-effect profile, and its cost, relative to the prescription medications for BPH.