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

University of Virginia

Status: Unknown

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

Treatments: Device: Embozene Microspheres

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02592473

18236

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Embozene Microspheres

Experimental group

Description:

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.

Treatment:

Device: Embozene Microspheres