Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).

Detailed Description
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This pilot study is a prospective, non-randomized clinical trial assessing the safety and feasibility of prostatic artery embolization. Fifty adult male subjects will be enrolled and treated in this study. Patients who provide informed consent and are deemed eligible for participation will undergo prostatic artery embolization in the Interventional Radiology department at the University of Virginia. After performing an angiogram to identify the prostatic arteries, tiny particles known as Embozene Microspheres will be injected into the prostatic artery. Injecting these particles into the prostatic artery will slow blood flow to the prostate and thus shrinking the size of the prostate. By shrinking the size of the prostate, it is hopeful that it will provide relief of lower urinary tract symptoms due to BPH. Subjects will be followed for 2 years as part of their participation in this study.

Official Title
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Prostate Artery Embolization Safety and Efficacy: A Pilot Study

Conditions
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Prostatic Hyperplasia, Benign Prostatic Hyperplasia (BPH), Prostatism, Lower Urinary Tract Symptoms (LUTS), Prostatic Hypertrophy, Hyperplasia, Male Urogenital Diseases, Genital Diseases, Male

Intervention / Treatment
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* Device: Embozene Microspheres


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between ages 45-80 years Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of <12mL/s (milliliters per second) . All prostate volumes will be at least 40gm and no more than 400gm based on DRE, TRUS, or cross sectional imaging Exclusion Criteria: Patients with urinary tract infections (> 2/year), prostatitis, or interstitial cystitis Cases of biopsy proven prostate cancer or urethral cancer. Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study. Patients who are classified as New York Heart Association Class III (Moderate), or higher. Patients with history of prior pelvic irradiation. Hypersensitivity reactions to contrast material not manageable with prophylaxis. Patients with serum creatinine values >1.7mg/dl or glomerular filtration rates less than 50.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 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: Embozene Microspheres<br>Embozene Microspheres are spherical particles consisting of a hydrogel core and a poly nanocoat that will be used during study procedure, Prostatic Artery Embolization (PAE) to reduce or eliminate bloodflow to the prostate. | Device: Embozene Microspheres<br>* Minimally invasive intra-arterial administration of particle embolics into prostate arteries under fluoroscopy and cone-beam CT imaging guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | QMax (peak urinary flow rate) assessment | 12 months | 
| Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures |  | 2 weeks | 
| Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | QMax assessment | 24 months | 
| Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures |  | 24 months | 
| Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | IPSS (International Prostate Symptom Score) | 12 months | 
| Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | IPSS | 24 months | 
| Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | QoL(quality of life question) | 12 months | 
| Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | QoL | 24 months | 
| Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | QMax | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine flow rate as measured by QMax |  | 1 month | 
| Urine flow rate as measured by QMax |  | 24 months | 
| Post-void residual measured in ml/cc |  | 1 month | 
| Post-void residual measured in ml/cc |  | 24 months | 
| UCLA-PCI-SF (University of California, Los Angeles Prostate Cancer Index Short Form) score |  | 1 month | 
| UCLA-PCI-SF score |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, Prostate Artery Embolization (PAE), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS), PAE, LUTS, Prostatic Artery Embolization