The Biostatistics Center of The George Washington University proposes to work in cooperative agreement with NIDDK to serve as the Data Coordinating Center for a proposed limited multicenter trial to determine the impact of different modes of drug treatment in reducing progression to surgery in men with benign prostatic hyperplasia (BPH). The objective of the nine month planning phase is to develop a protocol, case report forms, operations manual and data processing system to be implemented in a limited clinical trial. The trial will require the recruitment and randomization of at least 100 BPH patients over a one year period in four clinical centers. Eligible patients will be randomized either to a placebo or to one of three treatment groups (an alpha-1 adrenoceptor blocker, a 5-alpha reductase inhibitor, or both). Randomized patients will be followed for an average of 6 months (range: 2 to 12 months). The results of the limited clinical trial will be used to determine the feasibility of conducting a full-scale clinical trial by evaluation of patient recruitment, patient tolerance to and compliance with treatment regimens, and the usefulness of various serum and urodynamic measurements as markers of disease progression.
The specific aims of the Data Coordination Center during the BPH pilot study are to provide centralized biostatistical support and consultation in the areas of design (study protocol, case report forms, operations manual, randomization procedures, distributed data entry system, quality control procedures), execution (data processing support, data quality assessment, performance monitoring, interim analysis), and close-out, final analysis, and publication of pilot study data.
