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

Prostatic Hyperplasia Clinical Trial

Official title:

Prostate Artery Embolization Safety and Efficacy: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02592473
• Other study ID #: 18236
• Status: Recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: November 2021

Study information

• Verified date: April 2019
• Source: University of Virginia
• Contact: Joshua Feazell, BS
• Phone: 434-297-5682
• Email: JF9RF[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Embozene Microspheres
Minimally invasive intra-arterial administration of particle embolics into prostate arteries under fluoroscopy and cone-beam CT imaging guidance.

Locations

Country	Name	City	State
United States	University of Virginia Health Systems	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Siemens Medical Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement in Lower Urinary Tract Symptoms (LUTS)	QMax (peak urinary flow rate) assessment	12 months
Primary	Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures		2 weeks
Primary	Clinical improvement in Lower Urinary Tract Symptoms (LUTS)	QMax assessment	24 months
Primary	Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures		24 months
Primary	Clinical improvement in Lower Urinary Tract Symptoms (LUTS)	IPSS (International Prostate Symptom Score)	12 months
Primary	Clinical improvement in Lower Urinary Tract Symptoms (LUTS)	IPSS	24 months
Primary	Clinical improvement in Lower Urinary Tract Symptoms (LUTS)	QoL(quality of life question)	12 months
Primary	Clinical improvement in Lower Urinary Tract Symptoms (LUTS)	QoL	24 months
Primary	Clinical improvement in Lower Urinary Tract Symptoms (LUTS)	QMax	24 months
Secondary	Urine flow rate as measured by QMax		1 month
Secondary	Urine flow rate as measured by QMax		24 months
Secondary	Post-void residual measured in ml/cc		1 month
Secondary	Post-void residual measured in ml/cc		24 months
Secondary	UCLA-PCI-SF (University of California, Los Angeles Prostate Cancer Index Short Form) score		1 month
Secondary	UCLA-PCI-SF score		24 months