Clinical trial NCT03372096: LC Bead LUMI for Prostatic Artery Embolization
Official title: LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPH
Keywords: embolization
prostate
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: BTG International Inc.
First posted: 2017-12-13
Enrollment: 18
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size
Primary purpose: TREATMENT

Brief summary: Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine flow rate) changes, post void residual volume (PVR) changes, percent prostate infarction and presence of non-target embolization.

Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study.

Procedures (methods): This will be a multisite, open label pilot study with a small population undergoing an investigational intervention (prostatic artery embolization) to determine initial safety and potential for efficacy as measured by improvement of lower urinary tract symptoms (LUTS) and decrease in prostate size.

Detailed description: This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size

Eligibility criteria: Inclusion Criteria

1. Male
2. Age \> 40
3. Prostate gland \>50 grams as measured by pre-procedural CT angiogram (CTA)
4. Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects
5. Moderate to severe LUTS as defined by IPSS score \>18
6. Peak urine flow rate (Qmax) \<12 mL/sec
7. Capable of giving informed consent
8. Life expectancy greater than 1 year

Exclusion Criteria

1. Severe vascular disease
2. Uncontrolled diabetes mellitus
3. Immunosuppression
4. Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
5. Complete urinary retention
6. Impaired kidney function (serum creatinine level \> 1.8 mg/dL or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
7. Confirmed or suspected bladder cancer
8. Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
9. Ongoing urogenital infection
10. Previous pelvic radiation or radical pelvic surgery
11. Confirmed or suspected malignancy of the prostate based on digital rectal exam (DRE), transrectal ultrasonography (TRUS) or prostate-specific antigen (PSA) (\> 10 ng/mL or \> 4.0 ng/mL and \< 10 ng/mL with free PSA \< 25% of total PSA without a negative biopsy).
12. Uncorrectable coagulopathy including international normalized ratio (INR) \> 1.5 or platelets \< 50,000
13. Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)

Primary outcomes:
measure: Mean Change in IPSS Score
timeFrame: Baseline and 6 months following PAE procedure
Secondary outcomes:
measure: Mean Change in Quality of Life Scores
timeFrame: Baseline and 6 months following PAE procedure
measure: Mean Change in Urine Flow
timeFrame: Baseline and 6 months following PAE Procedure
measure: Mean Change in Prostate Volume
timeFrame: Baseline and 3 months following
measure: Percent of Prostate Infarcted
timeFrame: 6 months following PAE procedure
measure: Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure
timeFrame: 3 months following PAE procedure
measure: Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure
timeFrame: Up to 12 months following PAE procedure
measure: Mean Change in IIEF Score
timeFrame: Baseline and 6 months following PAE procedure
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
city: Woodbridge
country: United States
facility: Vascular Institute of Virginia
state: Virginia
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ari Isaacson, MD
role: PRINCIPAL_INVESTIGATOR
References: