Minimally Invasive Surgical Therapies (MIST) Treatment Consortium for Benign Prostatic Hyperplasia (BPH)

• Background
• Clinical Trial
• Recruiting Soon: see www.clinicaltrials.gov (Key word: MIST)

Background

The Division of Kidney and Urologic and Hematologic Diseases of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has had a substantial and longstanding interest in evaluating the effectiveness of treatment strategies for the symptoms of benign prostatic hyperplasia (BPH). For many years, transurethral resection of the prostate (TURP) has been the standard surgical therapy for this condition. However, during the past decade, a number of technical innovations have allowed the development of new surgical treatments that aim to achieve the same long-term outcomes of TURP but with less morbidity, lower costs, office-based treatment or shorter length of hospital stay, and more rapid recovery. These new, "minimally-invasive" surgical approaches include laser therapy, hyperthermia and thermotherapy, transurethral electrovaporization, microwave therapy, and transurethral needle ablation. Newer techniques are appearing regularly. Published reports on the outcomes of these minimally-invasive therapies are highly variable in their quality, and rigorously conducted randomized clinical trials have only rarely been conducted.

To assess the long-term safety and effectiveness of these new therapies, the NIDDK has formed a consortium of seven Prostate Evaluation Treatment Centers and a Biostatistical Coordinating Center to develop and conduct randomized, controlled, clinical trials that will give a clearer picture of the benefits and risks of these methods. The seven clinical centers are Baylor College of Medicine, Columbia University, Mayo Clinic, Milwaukee College of Medicine, Northwestern University, University of Colorado Health Science Center, and Texas Southwestern Medical Center. The Data Coordinating Center is at George Washington University.

Clinical Trial

The first trial to be conducted by the MIST consortium will evaluate the safety and effectiveness of transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and combined medical therapy with afuzosin, an alpha blocker, and finasteride, an alpha-reductase inhibitor. The primary outcome is treatment failure, determined by an objective set of criteria, within 36 months. The recruitment goal is 714 patients (238 per treatment group), and recruitment is scheduled to begin in spring 2004 (www.clinicaltrials.gov ). The trial will end in July 2008 with the last yearly follow-up exam. The results of the first trial will provide both physicians and patients with the knowledge needed to make the most appropriate choices for long-term management of BPH.

Project Officers: Dr. Leroy Nyberg and Dr. John Kusek, 301-594-7717