Comparison of Glue with Microparticles in Prostatic Artery Embolization

Официальное название

Comparison of the Efficacy and Safety of Glue with Calibrated Microparticles in Prostatic Artery Embolisation As a Treatment for Symptomatic Benign Prostatic Hyperplasia.

Обзор

Prostatic artery embolisation (PAE) is an alternative treatment to surgery for benign prostatic hyperplasia (BPH). It has been practised since 2012 and numerous publications have proved not only its safety but also its efficacy. The principle of PAE is to occlude the prostatic arteries with an 'embolising agent', which will result in ischaemia and necrosis of part of the adenomatous tissue of the prostate. The reference embolisation agent is a suspension of calibrated trisacryl microparticles 300-500 microns in size. Recently, the use of glue has been retrospectively studied with acceptable efficacy and safety. In this context, where only the results of retrospective studies are available, it is necessary to initiate comparative prospective studies to assess the efficacy and safety of the glue compared with calibrated microparticles.

Подробное описание

Prostatic artery embolisation (PAE) is an alternative treatment to surgery for benign prostatic hyperplasia (BPH), and its place is recognised in the recommendations of the Male Voiding Disorders Committee (French Urological Association). It has been practised since 2012 (Carnevale et al, 2020), and numerous publications have proved not only its safety but also its efficacy (Malling et al, 2019).

The principle of PAE is to occlude the prostatic arteries with an 'embolising agent', which will result in ischaemia and necrosis of part of the adenomatous tissue of the prostate.

The reference embolisation agent, used by the majority of expert prostate embolisation teams, is a suspension of calibrated trisacryl microparticles 300-500 microns in size.

Recently, the use of glue has been retrospectively studied with acceptable efficacy and safety (Loffroy et al, 2021). Another retrospective comparative study (Salet et al, 2022) reported no significant difference in clinical efficacy between the use of glue and 300-500 micron trisacryl particles.

In this context, where only the results of retrospective studies are available, it is necessary to initiate comparative prospective studies to assess the efficacy and safety of the glue compared with calibrated microparticles.

Вмешательства

• Устройство Embolisation with Magic Glue®
  Magic Glue® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland
• Устройство Embolisation with Embosphere®
  Embosphere® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland

Первичные конечные точки

• Efficacy of embolisation [Срок оценки: Month 3]

Вторичные конечные точки (9)

• Post-Mictional Residue [Срок оценки: Month 1, Month 3 and Month 12]
• Prostatic infarct areas [Срок оценки: Month 3]
• Sexual function [Срок оценки: Month 1, Month 3 and Month 12]
• Patient quality of life [Срок оценки: Month 1, Month 3 and Month 12]
• Prostatic Serum Antigen [Срок оценки: Month 1, Month 3 and Month 12]
• Urinary flow [Срок оценки: Month 1, Month 3 and Month 12]
• Prostatic volume [Срок оценки: Month 3 and Month 12]
• Efficacy of embolisation [Срок оценки: Month 1 and Month 12]
• Safety of embolisation [Срок оценки: Day 15, Month 3 and Month 12]

Критерии участия

Критерии включения

• Male patient aged ≥ 50 years and ≤ 80 years
• Patient with symptomatic BPH (prostatic volume ≥ 40 ml measured on prostatic MRI, IPSS ≥ 8, uroflowmetry < 15 ml/s).
• Patient failing or intolerant to drug treatment (tadalafil and/or one of the alpha-blockers, alfuzosin, tamsulosin, silodosin or doxazosin).

Критерии исключения

• Patient with advanced and complicated BPH on renal and bladder ultrasound:

Severe obstruction related bladder wall lesions : >3 micro-diverticula or single or multiple diverticula with a sac diameter > 10 mm.

Chronic dilatation of the excretory cavities : diameter of one or both pyelons >15 mm.

• Patient with suspected prostate or bladder cancer on MRI
• Patients with moderate or severe chronic renal failure, with creatinine clearance < 40 ml/min.
• Patient with prostate or bladder cancer diagnosed by biopsy in the 6 months preceding the inclusion visit.
• Patient with an active urinary tract infection
• Patient already included and participating in another clinical study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Clinique de l'Alma — Paris

Идентификаторы

NCT: NCT06678308 · 2023-08 · ID-RCB number: 2024-A01753-44

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗