Two different types of medical therapy for the symptoms of benign prostatic hyperplasia (BPH) now have been approved by the U.S. Food and Drug Administration. The first was finasteride, a 5-alpha reductase inhibitor; the other was terazosin, a selective alpha-1-adrenergic receptor inhibitor. Both of these drugs as well as other alpha blockers, such as doxazosin and prazosin, now are being used widely in the United States and around the world, both by urologists and primary care physicians, to treat the symptoms of prostatism. However, it is not known whether treatment with these agents will reduce or prevent the clinical progression of BPH when these medications are taken chronically. Clinically important BPH endpoints include acute urinary retention, increasing renal failure, severe bladder decompensation with chronic retention and incontinence, recurrent urinary tract infections and progressive voiding symptoms requiring surgical intervention. The Urology and Clinical Trials Program of the NIH NIDDK appropriately has developed a prospective randomized clinical research study investigating the long- term medical therapy of BPH using finasteride, doxazosin, the combination of finasteride and doxazosin, and a placebo arm. With this application, clinical research personnel from the Mayo Clinic Department of Urology (Rochester, Minnesota) are applying to be one of the """"""""Clinical Centers"""""""" as described in the new RFA. Our research group seeks to further utilize talent and experience generated over the preceding six years by Mayo personnel prospectively studying men with BPH. We already have had extensive experience in conducting multi-center prospective clinical trials investigating the natural history of BPH without treatment, and also in numerous multi-center prospective randomized industry sponsored clinical trials investigating finasteride, alpha- blockers and new devices for BPH. Our clinical research team also has had current experience in enrolling over 400 middle-aged male patients in the past eight months for the new NCI-SWOG chemoprevention trial of prostate cancer (PCPT) which has finasteride and placebo arms and which has many similarities to the proposed NIDDK BPH study in terms of overall organization of the multi-center trial and duration. We believe the ability and experience of the Mayo Clinic Department of Urology clinical investigation team in carrying out prospective trials of prostate disease should make us a strong candidate to become one of the clinical centers as described in the current NIDDK RFA.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK049912-06
Application #
6176980
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Kusek, John W
Project Start
1995-04-27
Project End
2002-03-31
Budget Start
2000-04-01
Budget End
2001-03-31
Support Year
6
Fiscal Year
2000
Total Cost
$266,297
Indirect Cost
Name
Mayo Clinic, Rochester
Department
Type
DUNS #
City
Rochester
State
MN
Country
United States
Zip Code
55905
Kaplan, Steven A; Lee, Jeannette Y; O'Neill, Edward A et al. (2013) Prevalence of low testosterone and its relationship to body mass index in older men with lower urinary tract symptoms associated with benign prostatic hyperplasia. Aging Male 16:169-72
Kaplan, Steven A; Lee, Jeannette Y; Meehan, Alan G et al. (2011) Long-term treatment with finasteride improves clinical progression of benign prostatic hyperplasia in men with an enlarged versus a smaller prostate: data from the MTOPS trial. J Urol 185:1369-73
Kaplan, Steven A; Roehrborn, Claus G; McConnell, John D et al. (2008) Long-term treatment with finasteride results in a clinically significant reduction in total prostate volume compared to placebo over the full range of baseline prostate sizes in men enrolled in the MTOPS trial. J Urol 180:1030-2;discussion 1032-3
Johnson 2nd, Theodore M; Burrows, Pamela K; Kusek, John W et al. (2007) The effect of doxazosin, finasteride and combination therapy on nocturia in men with benign prostatic hyperplasia. J Urol 178:2045-50;discussion 2050-1
Crawford, E David; Wilson, Shandra S; McConnell, John D et al. (2006) Baseline factors as predictors of clinical progression of benign prostatic hyperplasia in men treated with placebo. J Urol 175:1422-6; discussion 1426-7
Kaplan, Steven A; McConnell, John D; Roehrborn, Claus G et al. (2006) Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater. J Urol 175:217-20; discussion 220-1
McConnell, John D; Roehrborn, Claus G; Bautista, Oliver M et al. (2003) The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med 349:2387-98