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Grant Abstract

Grant Number: 2U01DK063788-08
PI Name: WILLIAMS, O. DALE
Project Title: CONTINUING APPLICATION FOR THE DATA COORDINATING CENTER FOR (CAMUS) TRIAL (U01)

Abstract: 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.

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