LC Bead LUMI for Prostatic Artery Embolization

LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: BPH
• Intervention / Treatment: Device: Prostatic Artery Embolization

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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Unc Hospitals
  • Virginia
    • Woodbridge, Virginia, United States, 22193
      • Vascular Institute of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All patients; Patients will receive the Prostatic Artery Embolization procedure.	Device: Prostatic Artery Embolization; LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred.; Other Names: LC Bead LUMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in IPSS Score	The International Prostate Symptom Score (IPSS) is an 8 item Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. IPSS is a written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35).	Baseline and 6 months following PAE procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Quality of Life Scores	The QoL question is a single question included with the IPSS related to the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores indicate a higher quality of life. The range of this scale is 0 to 5.	Baseline and 6 months following PAE procedure
Mean Change in Urine Flow	Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second.	Baseline and 6 months following PAE Procedure
Mean Change in Prostate Volume	Change in the prostate volume measured in grams.	Baseline and 3 months following
Percent of Prostate Infarcted	Percentage of prostate infarcted will be determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast CT images. Segmentation software will then be employed to calculate the volume.	6 months following PAE procedure
Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure	Number of participants that have non-targeted embolization following the prostatic artery embolization (PAE) procedure. Non-target embolization will be determined by comparing non-contrast CT images from pre- and post-PAE scans or clinical symptoms. This will be a binary data point and not a calculation.	3 months following PAE procedure
Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure	Number of participants that experience minor complications following the PAE procedure.	Up to 12 months following PAE procedure
Mean Change in IIEF Score	Change in sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire. The International Index of Erectile Function is a 15 question tool that measures erectile function (30 max), orgasmic function (10 max), sexual desire (10 max), intercourse satisfaction (15 max), and overall satisfaction (10 max). The total maximum score is 75. Higher scores indicated higher levels of sexual function.	Baseline and 6 months following PAE procedure

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: BTG International Inc.
• Investigators: Principal Investigator: Ari Isaacson, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2018
• Primary Completion (Actual): September 3, 2020
• Study Completion (Actual): September 3, 2020

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: prostate; embolization
• Other Study ID Numbers: 17-2782

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes