PD24-03 efficacy and safety of afalaza in MEN with symptomatic benign prostatic hyperplasia at risk of progression: a multicenter, double-blind, placebo-controlled, randomized clinical trial
Abstract
INTRODUCTION AND OBJECTIVES: Benign prostatic hyperplasia (BPH) and associated lower urinary tract symptoms (LUTS) are a prevalent and progressive condition in aging men. To investigate the efficacy and safety of Afalaza in men with BPH at risk of progression the multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. Derived by technological treatment of antibodies to prostate-specific antigen and endothelial NO synthase Afalaza was previously proved to modulate its molecular targets. METHODS: 249 patients of 45-60 years old with BPH and moderate LUTS, total prostate volume (TPV) ≥ 30 cm3, maximum urine flow rate (Qmax) of 10-15 ml/s, and serum prostatic specific antigen (PSA) <4 ng/ml were randomly assigned to receive either Afalaza (n=125) or placebo (n=124) for 12 months. Interactive voice/web response randomization system based on a random number generator was used for patients` randomization. Changes in BPH/LUTS symptoms (according to the International Prostate Symptom Score [IPSS]), Qmax, TPV, PSA, BPH clinical progression, occurrence of acute urinary retention (AUR) events or BPH-related surgery were estimated as the study endpoints. The study was conducted in accordance with the all ethic principles and was approved by the National Ethics Committee. RESULTS: IPSS mean (±standard deviation) change was -3.7±3.0 (95% confidence interval (CI) -4.3 to -3.2) after 12 months of Afalaza (vs. -2.9±2.4; 95% CI -3.3 to -2.4 in placebo; p=0.02).…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 249 participants or records.
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