This is an application to serve as a clinical center for the full-scale trial of medical therapy of BPH. The NIH-BPH study protocol will be followed in order to answer the primary research question of whether medical therapy (Finasteride and/or Doxazosin) delays or prevents the progression of BPH. A minimum of 200 study participants will be enrolled from our clinical center, although the ability to accrue and enlist a larger number of patients is anticipated. The target population from which study participants will be derived consist of the existing patient populations of the Vanderbilt Clinic and the Department of Veterans Affairs Medical Center in Nashville, groups which have provided a large number of participants for similar studies of BPH in recent years. To increase enrollment of black and minority patients, the Chairman of Urology at Meharry Medical College will participate in the study as a Co- Investigator. This arrangement will allow access to the patient population at Meharry-Hubbard Hospital and Nashville General Hospital, both of which see a predominantly African American patient group. Ongoing prostate cancer screening clinics which have been developed at several large employers and affiliated hospitals in the Nashville area will serve as an additional potential source of study participants. Although subjects will be identified through these various sources, all enrollment and follow-up will be performed in the Urology Clinic at Vanderbilt to assure accuracy and completeness of data collection. The existing Clinical Research Team of the Department of Urology will be utilized for the study. This research team has extensive experience in clinical trials including studies similar to the NIH-BPH trial. The ability to accrue and follow patients long-term has been well demonstrated at our center. Within a three month period, we enrolled 84 men on a prospective, long-term multi-institutional trial of medical treatment of BPH. In addition, we served as the Statistical and Coordinating Center as well as a study site for an NIH funded cooperative clinical trial of the use of ultrasound for evaluation of the prostate. We entered 293 patients into the study. Currently, we are participating in the NIH sponsored study for chemoprevention of prostate cancer. Of the more than 90 participating sites, we are the second leading institution in accruing patients to this study and have enrolled over 300 subjects. Our large existing patient base, targeted patient referrals for clinical trials, access to prostate cancer screening clinics, and use of the print and TV media for informational stories have all contributed to our successful efforts enrolling patients on cooperative multi-institutional clinical trials. We have developed specific strategies which have proven successful for maintaining long-term follow-up and compliance on our clinical trials. Methods for periodic contract with participating subjects via telephone and mail have been developed and will be used in the NIH-BPH trial. Quarterly informational symposia are held by our department for subjects participating in clinical trials to maintain interest and compliance.
