Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia

Summary

The primary objective of this trial is to compare the 9-month effect on lower urinary tract symptoms (LUTS) of Prostatic Artery Embolization (PAE) using Embosphere® versus Standard Combined Therapy (alpha-blockers plus 5 alpha-reductase inhibitors) in patients with symptomatic BPH who failed after a first line medical treatment with alpha-blockers. The secondary objectives of this study are to: * Estimate the impact of the 2 strategies on benign prostatic hyperplasia specific Health Status (i.e. urinary and sexual signs and symptoms) at 3, 9, 18, and 24 months, as well as the side effects of the 2 strategies; * Report the safety of PAE; * Evaluate patient's adherence to medical treatment; * Analyse the costs of each strategy and report the incremental efficiency (incremental cost utility ratio) of prostatic artery embolization compared to medical treatment.

Timeline

Start

2016-08

Primary completion

2020-12-03

Completion

2022-03-25

Publications

• Sapoval M, Thiounn N, Descazeaud A, Dean C, Ruffion A, Pagnoux G, Duarte RC, Robert G, Petitpierre F, Karsenty G, Vidal V, Murez T, Vernhet-Kovacsik H, de la Taille A, Kobeiter H, Mathieu R, Heautot JF, Droupy S, Frandon J, Barry Delongchamps N, Korb-Savoldelli V, Durand-Zaleski I, Pereira H, Chatellier G; PARTEM study group. Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trial. Lancet Reg Health Eur. 2023 Jun 26;31:100672. doi: 10.1016/j.lanepe.2023.100672. eCollection 2023 Aug.

Drugs

Indications