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

NCT03109925 | Unknown Phase 2 DMC

• 1 other identifier: RHMRAD0042
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

PAE; embolization; non-surgical; prostate artery embolization; radio-opaque embolic

Outcome Measures

Primary Outcomes (1)

• Adverse event rate

  Rate of adverse events compared with currently available other embolic agents

  12 months

Secondary Outcomes (1)

• Scale of symptomatic improvement

  12 months

Study Arms (1)

Radio-opaque embolic arm

EXPERIMENTAL

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

Interventions

DC Lumi Bead, BTG DEVICE

Embolic agent which is radio-opaque

Radio-opaque embolic arm

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• BTG International Inc.: collaborator

Study Sites (1)

Southampton General Hospital, University Hospital Southampton

Southampton, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Timothy Bryant

  University of Hospital Southampton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Drew Maclean

CONTACT

023 8120 8002; drew.maclean@uhs.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group of patients undergoing prostate artery embolization with a new embolic which is radio-opaque and can give a better idea of embolization distribution (DC Lumi Beads by BTG)

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: April 12, 2017
• Study Start: June 2, 2017
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

GB (1)