NCT06678308

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Dec 2024May 2027

First Submitted

Initial submission to the registry

November 6, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

2.5 years

First QC Date

November 6, 2024

Last Update Submit

November 6, 2024

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Post-Mictional Residue

    Month 1, Month 3 and Month 12

  • Prostatic infarct areas

    Month 3

  • Sexual function

    Month 1, Month 3 and Month 12

  • Patient quality of life

    Month 1, Month 3 and Month 12

  • Prostatic Serum Antigen

    Month 1, Month 3 and Month 12

  • +4 more secondary outcomes

Study Arms (2)

Magic Glue®

EXPERIMENTAL

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

Device: Embolisation with Magic Glue®

Embosphere®

ACTIVE COMPARATOR

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

Device: Embolisation with Embosphere®

Interventions

Embolisation with Magic Glue®DEVICE

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

Magic Glue®
Embolisation with Embosphere®DEVICE

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

Embosphere®

Eligibility Criteria

Age50 Years - 80 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 an active urinary tract infection
  • Patient already included and participating in another clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique de l'Alma

Paris, Paris, 75007, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeuticsTherapeutic Occlusion

Study Officials

  • Grégory AMOUYAL, MD

    Clinique de l'Alma

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grégory AMOUYAL, MD

CONTACT

+ 33 6 80 70 40 40dr.gregory.amouyal@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2024

First Posted

November 7, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

November 7, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)