Clinical trial NCT03109925: Use of a Novel Radiopaque Embolic Agent in Prostatic Artery Embolisation for Symptomatic Benign Prostatic Enlargement
Official title: Use of a Novel Radiopaque Embolic Agent in Prostatic Artery Embolisation for Symptomatic Benign Prostatic Enlargement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia
Keywords: PAE
embolization
non-surgical
prostate artery embolization
radio-opaque embolic
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: BTG International Inc.
First posted: 2017-04-12
Enrollment: 23
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse event rate
timeFrame: 12 months
Secondary outcomes:
measure: Scale of symptomatic improvement
timeFrame: 12 months
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Southampton General Hospital, University Hospital Southampton
Study officials:
affiliation: University of Hospital Southampton
name: Timothy Bryant
role: PRINCIPAL_INVESTIGATOR
References: