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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03109925
• Other study ID #: RHMRAD0042
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2, 2017
• Est. completion date: June 29, 2021

Study information

• Verified date: October 2020
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: Drew Maclean
• Phone: 023 8120 8002
• Email: drew.maclean[@]uhs.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: June 29, 2021
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• DC Lumi Bead, BTG
Embolic agent which is radio-opaque

Locations

Country	Name	City	State
United Kingdom	Southampton General Hospital, University Hospital Southampton	Southampton

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust	BTG International Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event rate	Rate of adverse events compared with currently available other embolic agents	12 months
Secondary	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