Study of Adalimumab Effects on Benign Prostatic Hyperplasia Symptoms and Prostate Inflammation in Men Aged 45 to 80

What this Trial Is About

Researchers are evaluating the effects of a drug called adalimumab, which blocks tumor necrosis factor TNF, in men with benign prostatic hyperplasia BPH, a condition involving prostate enlargement and inflammation. The study aims to see if this anti-inflammatory treatment can relieve symptoms, reduce prostate size, and lower inflammation in men with BPH who do not have autoimmune diseases. Researchers also seek to identify genetic factors that might predict how patients respond to this therapy. Participants will be randomly assigned to receive either adalimumab at a dose of 40 mg by subcutaneous injection every two weeks for a total of six doses or a placebo injection of saline on the same schedule. The study includes a treatment period of 12 weeks followed by monitoring to assess outcomes. The use of adalimumab in this context is investigational, as it is not approved for BPH but is commonly used for autoimmune diseases. During the study, participants will complete symptom questionnaires, provide medical information, and undergo assessments including measurement of prostate volume, urinary flow rates, and inflammation markers. Researchers will monitor safety using a standardized grading system throughout the 24-week study period. The total study duration includes initial treatment, follow-up visits, and outcome evaluations to understand the drugs impact on BPH symptoms and prostate health.

Effects of TNF Blockade on Human BPH/LUTS