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

NCT ID: NCT02592473

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2021-11-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Embozene Microspheres

Intervention Type: DEVICE

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

Interventions

Embozene Microspheres

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Siemens Medical Solutions

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Ziv Haskal, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ziv J Haskal, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Radiology

Locations

University of Virginia Health Systems

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joshua Feazell, BS

Role: CONTACT

JF9RF@virginia.edu

434-297-5682

Brigitte J Kelly, BSN RN CCRC

Role: CONTACT

bjk3c@virginia.edu

434-297-7136

Facility Contacts

Joshua Feazell, BS

Role: primary

jf9rf@virginia.edu

434-297-5682

Brigitte J Kelly, BSN RN CCRC

Role: backup

bjk3c@virginia.edu

434-297-7136

Other Identifiers

18236

Identifier Type: -

Identifier Source: org_study_id