Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia

Prospective, Controlled Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia

The purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostate artery embolization (PAE) with microspheres (Embozene™, 400µm) compared to conventional Holmium laser enucleation of the prostate (HoLEP).

Study Overview

• Status: Unknown
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: Holmium laser enucleation of the prostate; Procedure: Artery embolization of the prostate

Detailed Description

This is a prospective randomized controlled study that collects data of patients with benign prostatic hyperplasia that are treated with prostatic artery embolization (PAE) or with Holmium laser enucleation of the prostate (HoLEP). For PAE a catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate. The injected microspheres will slow the blood flow to the prostate. For HoLEP a Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra. Clinical follow-up include clinical visit after 1, 6 and 12 months. Acute as well as long term complications will be recorded. The patients fill in the questionnaires for urologic disease. Urodynamic examination will record functional outcome.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernando Agreda, MD; Phone Number: +34934893000; Email: fagreda.germanstrias@gencat.cat
• Study Contact Backup: Name: Jaume Sampere, MD; Phone Number: +34934893000; Email: jsampere.germanstrias@gencat.cat

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias I Pujol
      • Contact: Fernando Agreda, MD; Phone Number: +34934893000; Email: fagreda.germanstrias@gencat.cat
      • Contact: Jaume Sanpere, MD; Phone Number: +34934893000; Email: fagreda.germanstrias@gencat.cat
      • Principal Investigator: Fernando Agreda, MD
      • Sub-Investigator: Jaume Sanpere, MD
      • Sub-Investigator: Gerardo Tovar, MD
      • Sub-Investigator: Daniel Salvador, MD
      • Sub-Investigator: Mauro Bernardello, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Patients evaluated in the urology department and candidates to surgical treatment
• Age > 45 years
• IPSS ≥ 10
• Maximum urinary flow < 12 milliliters (mL)/second (s)
• Post-void residual urinary volume < 300mL
• Prostatic volume between 20mL and 250mL assessed by ultrasound
• Signed informed consent

Exclusion Criteria:

• PSA > 10 (if not negative prostate biopsy)
• Life expectancy below 1 year
• Renal insufficiency defined as Glomerular Filtration Rate < 30 ml/min/1,73m2
• Known severe reactions to iodine-based contrast or gadolinium-based contrast
• CT examination reveals no access to the prostate arteries.

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: Holmium laser enucleation of the prostate; Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra	Device: Holmium laser enucleation of the prostate; Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra
Active Comparator: Artery embolization of the prostate; A catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate. The injected microspheres will slow the blood flow to the prostate.	Procedure: Artery embolization of the prostate; A catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of symptoms assessed by International Prostate Symptom Score (IPSS)	Change in prostatic symptoms using the International Prostate Symptom Score (IPSS). IPSS score goes from 0 to 35. Higher values mean worse outcome (prostate symptons)	Baseline to 6 months after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum urinary flow	Maximum urinary flow rate (Qmax). Evaluated in milliliter per seconds (mL/s).	Baseline to 6 months after procedure
Post-void residual urinary volume	Post-void residual urinary volume (PVR). Post-void urinary volume: evaluated in milliliters (mL)	Baseline to 6 months after procedure
Prostate specific antigen (PSA)	Determination in plasma of the prostate specific antigen (PSA)	Baseline to 6 months after procedure
Procedure related adverse events	Evaluation of Procedure related adverse events assessed by Clavien-Dindo modified score. Clavien Dindo modified score: the score goes from 1 to 5. Higher values mean worse outcome (surgical complications)	Baseline to 6 months after procedure
Procedure related effects on sexual function	Changes in sexual function assessed by International Index of Erectile Function (IIEF) score. IIEF: the score goes from 6 to 75. Lower values mean worse outcome (overall male sexual function).	Baseline to 6 months after procedure
Procedure related effects on urinary continence	Changes in urinary continence assessed by the International Consultation on Continence Questionnaire Short Form (ICIQ-SF). ICIQ-SF: score goes from 0 to 21. Higher values mean worse outcome (urinary continence)	Baseline to 6 months after procedure

Collaborators and Investigators

• Sponsor: Germans Trias i Pujol Hospital
• Investigators: Principal Investigator: Fernando Agreda, MD, Germans Trias I Pujol Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 21, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: HBP01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No