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

Almaviva Sante

Status: Not yet enrolling

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: Embolisation with Embosphere®; Device: Embolisation with Magic Glue®

Study type: Interventional

Funder types: Other

Identifiers

NCT06678308

2023-08

ID-RCB number: 2024-A01753-44 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Magic Glue®

Experimental group

Description:

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

Treatment:

Device: Embolisation with Magic Glue®

Embosphere®

Active Comparator group

Description:

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

Treatment:

Device: Embolisation with Embosphere®