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

Phase 2

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Device: DC Lumi Bead, BTG

• Registration Number: NCT03109925
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-03-13
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Study Start: 2017-06-02
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-06-29
• Study Completion: 2021-06-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radio-opaque embolic arm	DC Lumi Bead, BTG	Patients will undergo intervention in the form of prostate artery embolization with the new radio-opaque embolic "Lumi-Bead" developed by BTG plc.

Primary Outcome Measures

Name	Time	Method
Adverse event rate	12 months	Rate of adverse events compared with currently available other embolic agents

Secondary Outcome Measures

Name	Time	Method
Scale of symptomatic improvement	12 months	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

Trial Locations

Locations (1)

Southampton General Hospital, University Hospital Southampton; 🇬🇧 Southampton, United Kingdom