Through this application, Baylor College of Medicine responds to RFA: DK-O1-024, Minimally Invasive Surgical Therapies (MIST) Treatment Consortium for BPH. Under the leadership of investigators with a wide range of interests including clinical and basic research in BPH and prostate cancer, clinical trials recruitment and management, and minority health issues, the Baylor Prostate Center proposes to serve as a Prostate Evaluation and Treatment Center (PETC) within the MIST consortium which will work cooperatively with the other PEWS, the BCC, and the NIDDK Project Coordinator to design and conduct randomized, controlled clinical trials of the long-term efficacy and safety of the major """"""""minimally invasive"""""""" approaches for the treatment of symptomatic BPH. Drawing from a population of almost 3,000 men over the age of 50 with an AUA symptom score > 15 and not previously treated for BPH, the Baylor PETC pledges with reasonable assurance to randomize up to 200 patients, including a minimum of 10 percent minority participation, on an agreed upon clinical trials protocols over a 3-year recruitment phase due to the unique resources committed to the successful outcome of this trial. The Baylor PETC will build on the considerable experience and expertise gained from the MTOPS Trial, including expertise in study design, large-scale patient recruitment, patient retention and maintenance on study protocols, transrectal ultrasound and biopsy of the prostate, and cooperative study performance to help ensure the success of this Consortium. Furthermore, the experience gained by the Baylor Prostate Center?s participation as a SPORE in Prostate Cancer will further support our PETC. Through the efforts of this RFA proposal, the Baylor Prostate Evaluation and Treatment Center, along with the other centers and the NIDDK, hopes to answer important questions regarding the respective roles of medical therapy and minimally invasive surgical therapy in the treatment of patients with BPH, the identification of the most efficacious, durable, and cost-effective minimally invasive modalities, and to gain insight into the clinical, pathological, and molecular correlates that determine response to these therapies.
| Crawford, E David; Hirst, Kathryn; Kusek, John W et al. (2011) Effects of 100 and 300 units of onabotulinum toxin A on lower urinary tract symptoms of benign prostatic hyperplasia: a phase II randomized clinical trial. J Urol 186:965-70 |
