Comparison of Glue with Microparticles in Prostatic Artery Embolization (EMBOLICOL)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: Embolisation with Magic Glue®; Device: Embolisation with Embosphere®

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grégory AMOUYAL, MD; Phone Number: + 33 6 80 70 40 40; Email: dr.gregory.amouyal@gmail.com

Study Locations

• France
  • Paris, France, 75007
    • Clinique de l'Alma
    • Contact: Grégory AMOUYAL, MD; Phone Number: +33 6 80 70 40 40; Email: dr.gregory.amouyal@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magic Glue®; Embolisation of the prostatic arteries will be performed with Magic Glue® combined with lipiodol	Device: 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
Active Comparator: Embosphere®; Embolisation of prostatic arteries will be performed with 300-500 micron trisacryl particles (Embosphere®)	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of embolisation	Efficacy of embolisation will be assessed with IPSS score (International Prostate Symptoms Score). IPSS questionnaire consists of 7 questions (ranging from 0 to 5) on mictional difficulties for a maximum total of 35 points (0 means no mictional difficulty).	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Mictional Residue	Post-Mictional Residue will be assessed will be measured in ml by ultrasound	Month 1, Month 3 and Month 12
Prostatic infarct areas	Prostatic infarct areas will be measured in mm3 on MRI	Month 3
Sexual function	Sexual function will be assessed with IIEF5 questionnaire (International Index of Erectile Function form 5) (0 - 25 points). Score lower than 10 means severe erectile dysfunction whereas score higher than 20 means normal erectile function.	Month 1, Month 3 and Month 12
Patient quality of life	Patient quality of life will be assessed with IPSS quality of life question (1 - 7). 1 means patient is very satisfied of his/her quality of life	Month 1, Month 3 and Month 12
Prostatic Serum Antigen	Prostatic Serum Antigen (PSA) will be measured from blood sample. Normal value should be lower than 4 ng/ml	Month 1, Month 3 and Month 12
Urinary flow	Urinary flow will be measured in ml/s by flow measurement	Month 1, Month 3 and Month 12
Prostatic volume	Prostatic volume will be in ml on MRI	Month 3 and Month 12
Efficacy of embolisation	Efficacy of embolisation will be assessed with IPSS score (International Prostate Symptoms Score). IPSS questionnaire consists of 7 questions (ranging from 0 to 5) on mictional difficulties for a maximum total of 35 points (0 means no mictional difficulty).	Month 1 and Month 12
Safety of embolisation	Safety of embolisation will be assessed with post-empbolisation symptoms description and other adverse events description	Day 15, Month 3 and Month 12

Collaborators and Investigators

• Sponsor: Almaviva Sante
• Investigators: Principal Investigator: Grégory AMOUYAL, MD, Clinique de l'Alma

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Estimated): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 2023-08; ID-RCB number: 2024-A01753-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No