The MTOPS Study: New Findings, New Insights, and Clinical Implications for the Management of BPH

Benign prostatic hyperplasia (BPH) affects an increasing number of men as they age and can progress in a certain proportion, resulting in serious complications such as acute urinary retention (AUR) and BPH-related surgery. The Medical Therapy of Prostatic Symptoms (MTOPS) Study was a large-scale, long-term study with a recruitment of 3047 men with BPH and a mean follow-up period of 4.5 yr. The study found that combination therapy with a selective type 2 5α-reductase inhibitor (finasteride) and an α1-blocker (doxazosin) provided benefits over either drug as monotherapy in terms of reduction in the risk of clinical progression. Data from the MTOPS Study corroborate earlier evidence of the prognostic power of baseline prostate-specific antigen (PSA) levels and prostate volume. Patients with higher PSA values and prostate volumes have worse outcomes as seen in deteriorating symptom scores, development of AUR, and the need for invasive surgery. Recent analyses of the MTOPS Study have been conducted to identify which patients should be considered for combination therapy. Findings suggest that patients with BPH with a prostate volume ≥25 ml and a PSA of ≥1.5 ng/ml may benefit from combination therapy. In addition, analysis of the placebo arm of the study reveals that patients with a baseline prostate volume of ≥31 ml and a PSA of ≥1.5 ng/ml are at a significantly greater risk of clinical progression. As such, combination therapy is strongly indicated in this patient group.