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

Prostate Artery Embolization Safety and Efficacy: A Pilot Study

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).

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joshua Feazell, BS; Phone Number: 434-297-5682; Email: jf9rf@virginia.edu
• Study Contact Backup: Name: Brigitte J Kelly, BSN RN CCRC; Phone Number: 434-297-7136; Email: bjk3c@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia Health Systems
      • Contact: Joshua Feazell, BS; Phone Number: 434-297-5682; Email: jf9rf@virginia.edu
      • Contact: Brigitte J Kelly, BSN RN CCRC; Phone Number: 434-297-7136; Email: bjk3c@virginia.edu
      • Principal Investigator: Ziv J Haskal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Embozene Microspheres; Minimally invasive intra-arterial administration of particle embolics into prostate arteries under fluoroscopy and cone-beam CT imaging guidance.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Siemens Medical Solutions
• Investigators: Principal Investigator: Ziv J Haskal, MD, Professor of Radiology

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia (BPH); Lower Urinary Tract Symptoms (LUTS); LUTS; BPH; PAE; Prostatic Artery Embolization; Prostate Artery Embolization (PAE)
• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Pathological Conditions, Anatomical; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms; Hypertrophy; Prostatism
• Other Study ID Numbers: 18236

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes