The objective of this two-by-two, prospective, blinded trial is to determine if finasteride and/or doxazosin will delay or alter the development of benign prostatic hyperplasia (BPH) in a population of at- risk men with mild to moderate symptoms of BPH. Progression of BPH will be defined as development of urinary retention, renal insufficiency, urinary tract infections, or incontinence as well as an increase in the AUA symptom score of greater than or equal to 4 points. The trial includes a two-year accrual phase followed by four years of follow-up and a one-year study closeout period. From a large population of retired military health care beneficiaries in the San Antonio metropolitan area, including a large proportion of African American and Hispanic men, the Urology Service, BAMC proposes to identify eligible men for the trial, conduct regular screening clinics and randomize 200 men during a two year period. Particular emphasis will be placed on recruitment of minority populations. Compliance to the dosing schedule of study drugs will be assured through a schedule of regular telephone contacts with participants and will be monitored through regular pill counts.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01DK049951-07S1
Application #
6594186
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Kusek, John W
Project Start
1995-04-27
Project End
2003-03-31
Budget Start
2001-04-01
Budget End
2003-03-31
Support Year
7
Fiscal Year
2002
Total Cost
$38,581
Indirect Cost
Name
Henry M. Jackson Fdn for the Adv Mil/Med
Department
Type
DUNS #
City
Rockville
State
MD
Country
United States
Zip Code
20817
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