EAU 2019: Efficacy and Safety of Afalaza in Men with Benign Prostatic Hyperplasia at Risk of Progression

Barcelona, Spain (UroToday.com) Benign prostatic hyperplasia (BPH) and associated lower urinary tract symptoms (LUTS) are a prevalent and progressive condition in aging men. The speakers discussed the therapeutic and secondary preventive efficacy and safety of Afalaza in men with BPH at risk of progression.  A 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.

According to the study, patients with BPH and moderate LUTS were randomly assigned to receive either Afalaza or placebo for 12 months. Changes in BPH/LUTS symptoms (IPSS), the occurrence of acute urinary retention (AUR) events or BPH-related surgery were estimated as the study endpoints.

Postoperative functional results after 12 months were significantly higher in the case of Afalaza to compare with placebo. PSA was remained unchanged. Afalaza therapy resulted in a significant decrease in the total sum of BPH progression factors. It is important to note that the maximum effect of Afalaza was registered after 12 months without a tendency to form a “plateau”. During the study, no patient experienced AUR or the development of conditions requiring BPH-related surgery. The incidence of adverse events did not differ between the groups, nor were there any serious ones.

Professor Vinarov concluded that 12-month Afalaza therapy is effective and safe for patients with BPH/LUTS. The endpoints measurements revealed the significant advantage of Afalaza compared to placebo in the overall symptoms’ benefit, a decrease in TPV and risk of BPH progression. However, the authors highlighted that confirmation and detail of the findings further research should be provided.

Presented by: Professor Andrey Vinarov, Sechenov University, Institute for Urology and Reproductive Health, Moscow, Russia 

Written by: Ekaterina Laukhtina, medical student, Institute for Urology and Reproductive Health, Sechenov University,  at the 34th European Association of Urology (EAU 2019) #EAU19 conference in Barcelona, Spain, March 15-19, 2019.