The Medical Therapy of Prostatic Symptoms (MTOPS) Trial tested whether finasteride (Proscar), doxazosin (Cardura) or a combination of the drugs could prevent progression of BPH and the need for surgery or other invasive treatments. Treatments were compared to placebo.

Physicians at 17 MTOPS medical centers treated 3,047 randomized men with BPH for an average of 4.5 years, much longer than previous studies. Vital signs, urinary symptoms, urinary flow, side effects and medication use were checked every 3 months and digital rectal exams, serum PSA and urine was checked yearly. Prostate size was measured at the beginning and end of the study by ultrasound. Progression of disease was defined by one of the following: a 4-point rise in the American Urological Association's symptom severity score, urinary retention (inability to urinate), recurrent urinary tract infection or urinary incontinence.

Finasteride, a 5 alpha-reductase inhibitor, and doxazosin, an alpha-1 receptor blocker, together reduced the overall risk of BPH progression by 66 percent compared to placebo. The combined drugs also provided the greatest symptom relief and improvement in urinary flow rate. Doxazosin alone reduced overall risk of progression by 39 percent and finasteride alone by 34 percent relative to placebo. The combination treatment and finasteride alone also significantly reduced the risk of invasive therapy by 67 percent and 64 percent, respectively. Doxazosin did not reduce the long-term risk of invasive therapy. Most invasive treatments in MTOPS were transurethral or open surgeries to remove prostate tissue
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Contact: Mary Harris
301-496-3583
NIH/National Institute of Diabetes and Digestive and Kidney Diseases
17-Dec-2003