LC Bead LUMI for Prostatic Artery Embolization

Study Overview
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Brief Summary
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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
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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

Official Title
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LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study

Conditions
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BPH

Intervention / Treatment
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* Device: Prostatic Artery Embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male Age > 40 Prostate gland >50 grams as measured by pre-procedural CT angiogram (CTA) Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects Moderate to severe LUTS as defined by IPSS score >18 Peak urine flow rate (Qmax) <12 mL/sec Capable of giving informed consent Life expectancy greater than 1 year Exclusion Criteria Severe vascular disease Uncontrolled diabetes mellitus Immunosuppression Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc. Complete urinary retention 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. Confirmed or suspected bladder cancer Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology Ongoing urogenital infection Previous pelvic radiation or radical pelvic surgery 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). Uncorrectable coagulopathy including international normalized ratio (INR) > 1.5 or platelets < 50,000 Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients<br>Patients will receive the Prostatic Artery Embolization procedure. | Device: Prostatic Artery Embolization<br>* 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.<br>* Other names: LC Bead LUMI;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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embolization, prostate