Use of a Novel Radiopaque Embolic Agent in Prostatic Artery Embolisation for Symptomatic Benign Prostatic Enlargement

This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a better understanding of embolic distribution.

Study Overview

• Status: Unknown
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: DC Lumi Bead, BTG

Detailed Description

This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a better understanding of embolic distribution. It would also give us answers to:

• How does embolic efficacy compare to current available embolic agents?
• Does enhancement on rotational CT correlate with embolic distribution?
• How does embolic distribution compare with tissue infarction?
• Does the density of embolic packing correlate with degree of infarction and volume loss?
• How predictable is superselective target embolisation?
• Does embolic distribution vary with anatomy and gland size?
• Does embolic distribution tally with glandular enhancement/ transitional zone vascularity?
• If visible, what is the effect and significance of non target embolisation? This is a cohort study aiming to recruit 22 patients to power a non-inferiority assessment comparing the novel embolic agent against current available embolics.

Data will be added to our on going local registry of patients who have undergone this procedure . This will provide information about how safe and effective it is for patients and how it compares to the other established embolic agents such as polyvinyl alcohol (PVA) and other spherical agents such as Embospheres and Embozenes.

• Study Type: Interventional
• Enrollment (Anticipated): 23
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Drew Maclean; Phone Number: 023 8120 8002; Email: drew.maclean@uhs.nhs.uk

Study Locations

• United Kingdom
  • Southampton, United Kingdom
    • Recruiting
    • Southampton General Hospital, University Hospital Southampton
    • Contact: Michelle Beveridge
    • Contact: Andrew Guy
    • Principal Investigator: Timothy Bryant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Age 50-80 Moderate to severe lower urinary tract symptoms secondary to benign prostatic enlargement (BPE) IPSS>14, QOL≥4 Prostate volume ≥ 40 cc Maximum urinary flow rate < 12ml/s Medically refractory BPE > 6 months (or unable/ unwilling to tolerate medical treatment due to side effects)

Exclusion Criteria:

• Atherosclerosis of the prostatic arteries Surgical indications (Chronic retention, bladder diverticulae, urethral stenosis), detrusor instability, neurogenic bladder Malignancy (TRUS/ MRI/ Biopsy proven). PSA > 4 or high SWOP risk need prostate biopsy Urodynamics - non-obstructed eGFR ≤ 45ml min-1m-2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radio-opaque embolic arm; Patients will undergo intervention in the form of prostate artery embolization with the new radio-opaque embolic "Lumi-Bead" developed by BTG plc.	Device: DC Lumi Bead, BTG; Embolic agent which is radio-opaque

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event rate	Rate of adverse events compared with currently available other embolic agents	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scale of symptomatic improvement	symptomatic improvement will be gauged used the internationally recognised IPSS questionnaire. Decrease in IPSS score in study participants will be compared against other embolic agents in the literature	12 months

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Collaborators: BTG International Inc.
• Investigators: Principal Investigator: Timothy Bryant, University of Hospital Southampton

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2017
• Primary Completion (Anticipated): June 29, 2021
• Study Completion (Anticipated): June 29, 2021

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: embolization; PAE; non-surgical; prostate artery embolization; radio-opaque embolic
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: RHMRAD0042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Currently there is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No