MEDICAL THERAPY IN BPH--FULL SCALE TRIAL

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This proposal outlines our plan as a Clinical Center to implement the protocol developed by the Benign Prostatic Hyperplasia (BPH) steering committee for the clinical trial of medical therapy in BPH. The protocol is designed to evaluate men with moderate and severe symptoms of prostatism, randomized into one of 4 study arms consisting of doxazosin, finasteride, doxazosin and finasteride, and placebo. Specifically, we detail how we will coordinate efforts to recruit, evaluate, treat and follow up at least 200 patients in the time frame required. The investigators have extensive experience and expertise not only in the clinical and epidemiological aspects of BPH, but also in the design, conduct and implementation of collaborative clinical trials on the pharmacologic treatment of BPH. Over the pst three years, the HFHS/William Beaumont group has demonstrated the ability to successfully collaborate in an ongoing multicenter NIH U01 cooperative study. An objective of this study is to collaborate fully with other Clinical Centers. All the required data will be sent to the Data Coordinating Center and the appropriate specimens will be sent to the Diagnostic Center for proper processing. Another objective of this study is the timely recruitment of eligible patients including a representative number of minority patients. The Henry Ford/Beaumont Centers draw from a large population with unique demographics including an established relationship with a large minority population. In our ongoing NIH collaborative study we are leading in minority recruitment. In concert with public relations an intensive marketing plan has been developed. Additionally, we have established a relationship with local industry to promote accrual and to provide unique economic data on the direct and indirect costs of BPH treatment. The Henry Ford/Beaumont Center has the appropriate environment and physical facilities to perform as a clinical center. The clinical and laboratory space, ultrasound for prostate and post void residual, and complex urodynamic equipment are available. Significance experience with computers and appropriate data bases on an established system wide IBM compatible network will ensure consistent data collection throughout enrollment, intervention and follow up from the peripheral satellite facilities.