Minimally Invasive Surgical Therapies Consortium for BPH

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DESCRIPTION (provided by applicant): The George Washington University Biostatistics Center proposes to work in cooperative agreement with the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) to serve as the Biostatistical Coordinating Center (BCC) for the Minimally Invasive Surgical Therapies (MIST) Consortium for Benign Prostatic Hyperplasia (BPH). The prostate surgeries labeled minimally invasive offer exciting treatment alternatives to the gold standard, transurethral resection of the prostate (TURP). The proposed consortium?s objective is to design and conduct up to four randomized, controlled, multi-center clinical trials to determine the long-term efficacy and safety of minimally invasive therapies for symptomatic benign prostatic hyperplasia (BPH). Researchers and investigators from 15 prostate evaluation and treatment centers (PETC), the NIDDK Division of Kidney, Urologic, and Hematologic Diseases, and the BCC will comprise the consortium and collaborate under a cooperative agreement mechanism. The Steering and Planning Committee, composed of the principal investigators from the BCC and each PETC and the NIDDK project officer, will design and develop each of the clinical trials. The BCC will provide centralized support and biostatistical consultation in: the development of protocols, manuals of procedures, data collection forms, and randomization procedures; implementation of a data management system including data quality assessment; interim analysis of protocol performance, patient safety, and treatment efficacy; and final analysis for publication of results in collaboration with the clinical investigators. The BCC will establish a secure encrypted and password protected web site for study staff to enhance development, distribution, and use of study documents. The application includes a proposed protocol for a 3-arm, placebo/sham controlled, randomized, double-blind clinical trial to address whether the apoptotic effect of neoadjuvant and adjuvant finasteride in combination with the thermal effect of high-energy transurethral microwave thermotherapy (TUMT) act synergistically to destroy more BPH mass and improve outcome than either finasteride alone or TUMT alone. Success is defined as at least 30 percent improvement in AUA symptom score.