Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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Purpose: The purpose of this study is to determine if prostatic artery embolization (PAE) is as effective as medication (non-inferiority) in reducing urinary symptoms due to benign prostatic hyperplasia (BPH) and to determine if PAE will result in less adverse events compared to medication in individual patients. Participants: Study subjects will be 30 men who have taken BPH medication for at least 6 months and planning to undergo PAE. Subjects will be enrolled across 3 sites. Procedures (methods): This will be a single arm, non-blinded study of PAE using HydroPearl Beads. Subjects will be compared to themselves. The study will involve 6 study visits: an enrollment/baseline visit, the PAE procedure, and 1 day, 3 month, 6 month, and 12 month follow-up visits. Subjects will complete questionnaires and uroflowmetry testing at baseline and each follow-up visit. Subjects will also obtain an MRI at baseline and their 6 month follow-up visit.

Detailed Description
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This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of 30 subjects with benign prostate hyperplasia (BPH) to investigate the effectiveness of prostatic artery embolization (PAE) relative to previous medication alone for reducing urinary symptoms due to BPH. Secondary aims will be to assess adverse effects of medication vs adverse events secondary to PAE as well as Quality of Life scores on medication vs after PAE.

Official Title
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Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia: Single Subject Study Design

Conditions
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BPH, Enlarged Prostate (BPH), Prostatic Hyperplasia

Intervention / Treatment
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* Device: Prostatic Artery Embolization (HydroPearl® compressible microspheres)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Age ≥ 40 Prostate gland measures ≥50 grams measured by MRI, CT, or ultrasound Have previously taken BPH medications including either alpha blockers, 5-alpha reductase inhibitors or the combination of both for 6 months Capable of giving informed consent Life expectancy greater than 1 year Exclusion Criteria: Severe vascular disease as defined by severe arterial calcification seen on prior imaging, history of lower extremity or pelvic bypass grafts or history of lower extremity or pelvic arterial stenting. For patients that do not have prior imaging at UNC, we will rule out suspected severe arterial calcification given their medical history. Uncontrolled diabetes mellitus which is defined as A1C >8% Patients currently taking SGLT2 inhibitors (cana-, dapa-, empa-, and ertu- gliflozin) due to their diuretic effects A smoking history of 20 pack-year or greater obtained by patient report Prior myocardial infarction A stroke within the last 6 months Unstable angina 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 as assessed based on patients' medical history or current hematuria Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology Ongoing urogenital infection. For patients with symptoms of a urogenital infection (dysuria, fever, etc.), a urinalysis will be obtained. Previous pelvic radiation or radical pelvic surgery Confirmed malignancy of the prostate or a history of prostate cancer 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAE Procedure<br>This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of 30 subjects with benign prostate hyperplasia (BPH) | Device: Prostatic Artery Embolization (HydroPearl® compressible microspheres)<br>* Embolic material<br>* Other names: HydroPearl® compressible microspheres (75 to 400 µm);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in IPSS at 6 Months | The International Prostate Symptom Score (IPSS) is an 8 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 to 6 months following the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Quality of Life Scores at 6 Months | The QoL question is a single question included with the IPSS related to the symptoms of the disease benign prostatic hyperplasia (BPH) from 0 to 6. Lower scores indicate a higher quality of life. | baseline to 6 months following the procedure | 
| Mean Change in Curine Flow | Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second (mL/s) | Baseline to 6 months following the procedure | 
| Mean Change in Prostate Volume | Change in the prostate size measured in grams (g). | baseline to 6 months following the procedure | 
| 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 the procedure | 
| Incidence of Adverse Events | Percent of patients that experience adverse events following the PAE procedure. | up to 3 months following the procedure |