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.
