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

Not Applicable

• Conditions: Benign Prostatic Hyperplasia (BPH); Prostatism; Prostatic Hypertrophy; Prostatic Hyperplasia; Lower Urinary Tract Symptoms (LUTS); Hyperplasia; Male Urogenital Diseases; Genital Diseases, Male
• Interventions: Device: Embozene Microspheres

• Registration Number: NCT02592473
• Lead Sponsor: University of Virginia

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-30
• Study Start: 2015-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17
• Primary Completion: 2021-11
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Embozene Microspheres	Embozene Microspheres	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.

Primary Outcome Measures

Name	Time	Method
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)	24 months	QMax
Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures	24 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Virginia Health Systems; 🇺🇸 Charlottesville, Virginia, United States