Chronic Prostatitis Collaborative Clinical Trials

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DESCRIPTION (provided by applicant): This application reflects a proposal from the Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH) / Harvard Medical School to become one of the Clinical Centers of the Chronic Prostatitis Collaborative Research Network (CPCRN) to develop and conduct randomized clinical trials for evaluating novel therapies in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). The BWH/MGH Harvard clinical center has a history of successful recruitment and retention of CP/CPPS patients, including a substantial proportion of Latino patients, from the New England area for CPCRN 1997- 2003 - both for the Chronic Prostatitis Cohort Study and Randomized Clinical Trial. Drs. Mary McNaughton Collins and Michael O'Leary have advanced the field of CP/CPPS by helping to develop and validate the NIH-Chronic Prostatitis Symptom Index, translating the index to Spanish, evaluating the quality of life and resource utilization of men with CP/CPPS, as well as examining the epidemiology and natural history of the condition. Dr. McNaughton Collins has also performed several chronic prostatitis studies as a member of the Patient Outcomes Research Team (PORT) for Prostate Diseases and the Cochrane Collaboration. The BWH/MGH Harvard clinical center has expanded to include a multi-institutional and multi-disciplinary network of co-investigators and consultants with both content (i.e., chronic prostatitis, pain management) expertise and methodological (i.e., clinical trials, basic science, and outcomes research) training, as well as fresh sources of chronic prostatitis patients, especially newly diagnosed patients and minority patients. The new reservoirs of CP/CPPS patients include: 1) newly diagnosed CP/CPPS patients from primary care practices and medical walk-in units across the two large institutions and their neighborhood health centers, including the BWH internal medicine Spanish clinic; 2) both newly diagnosed and long-term CP/CPPS patients from the MGH Spanish urology clinic, and; 3) both newly diagnosed and long-term patients from Boston Medical Center, which is a large, inner-city academic health center providing care to a large proportion of African American patients. To assist in the recruitment and retention of Latino men, the site now includes 3 Spanish speaking medicine and urology investigators, and the Research Coordinator is taking Spanish classes to become proficient. This proposal includes a clinical trial design for consideration by the CPCRN. The multi-institutional, multi-disciplinary team from the BWH/MGH Harvard clinical center is eager to collaborate on treatment trials and ancillary studies with other CPCRN centers, the NIH/NIDDK scientific team, and the Interstitial Cystitis Clinical Trials Group.