The long-term objectives and specific aims of this proposal are to establish the University of Iowa Department of Urology and Preventive Medicine trials group as a Clinical Evaluation and Treatment Center (CETC) in a multi-institutional research consortium. The purpose of this consortium is to study the effect of phytotherapy using Sernoa repens (saw palmetto) and Pygeum africanum in men with benign prostatic hyperplasia (BPH). A large segment of the United States population uses phytotherapy for treatment of symptoms of BPH, yet there is little scientific data regarding long-term treatment with these agents. Our proposal here at the CETC will enroll 300 patients in this trial during the enrollment period and follow them for the duration of the trial for a minimum of four years and a maximum of six years. The primary outcome measure will be the clinical progression of BPH. The recruitment, marketing, and retention strategies outlined in the following sections will ensure this level of participation as well as maximize the center's ability to recruit minority populations. This center has all the clinical and laboratory support required as stated in the protocol. The following sections outline innovative methods to recruit a large number of men with BPH as well as multiple strategies to ensure long-term compliance and completion of all scheduled follow-up visits. In summary, this proposal outlines what we believe are the outstanding credentials of the University of Iowa Department of Urology and Preventive Medicine to serve as a Clinical Evaluation and Treatment Center for this multi-institutional clinical trial.
