Clinical trial NCT06678308: Comparison of Glue with Microparticles in Prostatic Artery Embolization
Official title: Comparison of the Efficacy and Safety of Glue with Calibrated Microparticles in Prostatic Artery Embolisation As a Treatment for Symptomatic Benign Prostatic Hyperplasia.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Almaviva Sante
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 96
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy of embolisation
timeFrame: Month 3
Secondary outcomes:
measure: Post-Mictional Residue
timeFrame: Month 1, Month 3 and Month 12
measure: Prostatic infarct areas
timeFrame: Month 3
measure: Sexual function
timeFrame: Month 1, Month 3 and Month 12
measure: Patient quality of life
timeFrame: Month 1, Month 3 and Month 12
measure: Prostatic Serum Antigen
timeFrame: Month 1, Month 3 and Month 12
measure: Urinary flow
timeFrame: Month 1, Month 3 and Month 12
measure: Prostatic volume
timeFrame: Month 3 and Month 12
measure: Efficacy of embolisation
timeFrame: Month 1 and Month 12
measure: Safety of embolisation
timeFrame: Day 15, Month 3 and Month 12
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique de l'Alma
Study officials:
affiliation: Clinique de l'Alma
name: Grégory AMOUYAL, MD
role: PRINCIPAL_INVESTIGATOR
References: