The Efficacy of TUMT and Neoadjuvant Finasteride for BPH

DESCRIPTION (provided by applicant):Benign prostatic hyperplasia (BPH) is the most common neoplastic conditionafflicting men and constitutes a major factor impacting the health of theAmerican 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 andsafety of minimally invasive therapies for symptomatic BPH includingTransurethral Microwave Thermotherapy (TUMT). The potential advantages of TUMTinclude the relief of LUTS with an in-office procedure using minimal anesthesiaand a rapid recovery. TUMT has been enthusiastically applied to patients withBPH, but reports suffer from lack of uniform outcome measurements and littledata on post-surgical pharmacological treatment. One of the goals stated in theRFA is to assess whether adjuvant medical therapy improves the long-termoutcome of MIST. In this light, we hypothesize that finasteride can augment thenecrosis of prostatic tissue undergoing TUMT by virtue of it ability to induceTGF-beta mediated apoptosis. We propose that this known effect of finasteridewill increase the "thermal kill" when used in a neoadjuvant setting with TUMTand result in an improved outcome.This is a truly exciting research direction, with considerable potentialramifications for both the patient and the health care delivery system. Wepropose an initial clinical trial to address whether the apoptotic effect ofneoadjuvant and adjuvant finasteride in combination with the thermal effect ofTUMT act synergistically to destroy more BPH mass and improve outcome thaneither finasteride alone or TUMT alone. We are proposing a 3-arm, placebo/shamcontrolled, randomized clinical trial using changes in symptoms as the primary