LC Bead LUMI for Prostatic Artery Embolization

BPH Clinical Trial

Official title:

LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372096
• Other study ID #: 17-2782
• Status: Completed
• Phase: N/A
• Start date: July 13, 2018
• Est. completion date: September 3, 2020

Study information

• Verified date: February 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 3, 2020
• Est. primary completion date: September 3, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• BPH

Intervention

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.

Locations

Country	Name	City	State
United States	UNC Hospitals	Chapel Hill	North Carolina
United States	Vascular Institute of Virginia	Woodbridge	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	BTG International Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Mean Change in Prostate Volume	Change in the prostate volume measured in grams.	Baseline and 3 months following
Secondary	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
Secondary	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
Secondary	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
Secondary	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