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

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01DK060795-01
Application #
6439363
Study Section
Special Emphasis Panel (ZDK1-GRB-6 (O2))
Program Officer
Kusek, John W
Project Start
2001-09-30
Project End
2006-08-31
Budget Start
2001-09-30
Budget End
2002-08-31
Support Year
1
Fiscal Year
2001
Total Cost
$100,000
Indirect Cost
Name
Northwestern University at Chicago
Department
Urology
Type
Schools of Medicine
DUNS #
005436803
City
Chicago
State
IL
Country
United States
Zip Code
60611
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
Helfand, Brian T; Mongiu, Anne K; Roehrborn, Claus G et al. (2009) Variation in institutional review board responses to a standard protocol for a multicenter randomized, controlled surgical trial. J Urol 181:2674-9
McVary, Kevin T (2009) Editorial comment. Urology 74:87; author reply 87-8
Dedhia, Raj C; Calhoun, Elizabeth; McVary, Kevin T (2008) Impact of phytotherapy on utility scores for 5 benign prostatic hyperplasia/lower urinary tract symptoms health states. J Urol 179:220-5