The Efficacy of TUMT and Neoadjuvant Finasteride for BPH

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DESCRIPTION (provided by applicant): Benign prostatic hyperplasia (BPH) is the most common neoplastic condition afflicting men and constitutes a major factor impacting the health of the American male. The objective of the Minimally Invasive Surgical Therapies (MIST) Consortium for BPH is to design and conduct up to several randomized, controlled, multicenter clinical trials to determine the long-term efficacy and safety of minimally invasive therapies for symptomatic BPH including Transurethral Microwave Thermotherapy (TUMT). The potential advantages of TUMT include the relief of LUTS with an in-office procedure using minimal anesthesia and a rapid recovery. TUMT has been enthusiastically applied to patients with BPH, but reports suffer from lack of uniform outcome measurements and little data on post-surgical pharmacological treatment. One of the goals stated in the RFA is to assess whether adjuvant medical therapy improves the long-term outcome of MIST. In this light, we hypothesize that finasteride can augment the necrosis of prostatic tissue undergoing TUMT by virtue of it ability to induce TGF-beta mediated apoptosis. We propose that this known effect of finasteride will increase the "thermal kill" when used in a neoadjuvant setting with TUMT and result in an improved outcome. This is a truly exciting research direction, with considerable potential ramifications for both the patient and the health care delivery system. We propose an initial clinical trial to address whether the apoptotic effect of neoadjuvant and adjuvant finasteride in combination with the thermal effect of TUMT act synergistically to destroy more BPH mass and improve outcome than either finasteride alone or TUMT alone. We are proposing a 3-arm, placebo/sham controlled, randomized clinical trial using changes in symptoms as the primary