Comparison of Glue with Microparticles in Prostatic Artery Embolization

NCT ID: NCT06678308

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-05-31

Brief Summary

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.

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Magic Glue®

Embolisation of the prostatic arteries will be performed with Magic Glue® combined with lipiodol

Group Type: EXPERIMENTAL

Embolisation with Magic Glue®

Intervention Type: DEVICE

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

Embosphere®

Embolisation of prostatic arteries will be performed with 300-500 micron trisacryl particles (Embosphere®)

Group Type: ACTIVE_COMPARATOR

Embolisation with Embosphere®

Intervention Type: DEVICE

Embosphere® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Almaviva Sante

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grégory AMOUYAL, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique de l'Alma

Locations

Clinique de l'Alma

Paris, Paris, France

Countries

France

Central Contacts

Grégory AMOUYAL, MD

Role: CONTACT

dr.gregory.amouyal@gmail.com

+ 33 6 80 70 40 40

Facility Contacts

Grégory AMOUYAL, MD

Role: primary

dr.gregory.amouyal@gmail.com

+33 6 80 70 40 40

Other Identifiers

ID-RCB number: 2024-A01753-44

Identifier Type: OTHER

Identifier Source: secondary_id

2023-08

Identifier Type: -

Identifier Source: org_study_id