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

PURPOSE: This post hoc analysis of the Medical Therapy of Prostatic Symptoms trial examined the effect of finasteride alone compared to placebo on the clinical progression of benign prostatic hyperplasia in men with a baseline prostate volume less than 30 ml, or 30 ml or greater. MATERIALS AND METHODS: Men were randomized to placebo (737), 4 to 8 mg doxazosin alone (756), 5 mg finasteride alone (768) or doxazosin plus finasteride (786) (average followup was 4.5 years). Approximately 50% of patients had a baseline prostate volume of 30 ml or greater. The present analysis was based on the finasteride alone and placebo arms only, and included patients for whom baseline and end of study data were available. We examined the effect of treatment on the cumulative percentage of men who did not experience clinical progression of benign prostatic hyperplasia by study end. RESULTS: In men with baseline prostate volume 30 ml or greater treatment with finasteride produced a significant (p <0.001) increase relative to placebo in the cumulative percentage of patients who did not experience clinical progression of benign prostatic hyperplasia (finasteride 88.1% vs placebo 77.8%). There was no significant (p = 0.441) between-group difference in men with baseline prostate volume less than 30 ml (91.4% vs 89.1%, respectively). CONCLUSIONS: Long-term treatment with finasteride led to a significant beneficial effect compared to placebo on the clinical progression of benign prostatic hyperplasia in patients with lower urinary tract symptoms with an enlarged prostate (baseline prostate volume 30 ml or greater). Finasteride had no significant effect compared to placebo on the clinical progression of benign prostatic hyperplasia in patients with lower urinary tract symptoms with a smaller prostate (baseline prostate volume less than 30 ml).