Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia

NCT ID: NCT04398966

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-23
• Study Completion Date: 2023-05-08

Brief Summary

Purpose: The purpose of this study is to determine if prostatic artery embolization (PAE) is as effective as medication (non-inferiority) in reducing urinary symptoms due to benign prostatic hyperplasia (BPH) and to determine if PAE will result in less adverse events compared to medication in individual patients.

Participants: Study subjects will be 30 men who have taken BPH medication for at least 6 months and planning to undergo PAE. Subjects will be enrolled across 3 sites.

Procedures (methods): This will be a single arm, non-blinded study of PAE using HydroPearl Beads. Subjects will be compared to themselves. The study will involve 6 study visits: an enrollment/baseline visit, the PAE procedure, and 1 day, 3 month, 6 month, and 12 month follow-up visits. Subjects will complete questionnaires and uroflowmetry testing at baseline and each follow-up visit. Subjects will also obtain an MRI at baseline and their 6 month follow-up visit.

Detailed Description

This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of 30 subjects with benign prostate hyperplasia (BPH) to investigate the effectiveness of prostatic artery embolization (PAE) relative to previous medication alone for reducing urinary symptoms due to BPH. Secondary aims will be to assess adverse effects of medication vs adverse events secondary to PAE as well as Quality of Life scores on medication vs after PAE.

Conditions

BPH; Enlarged Prostate (BPH); Prostatic Hyperplasia

Study Design

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

Study Groups

PAE Procedure

This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of 30 subjects with benign prostate hyperplasia (BPH)

Group Type: EXPERIMENTAL

Prostatic Artery Embolization (HydroPearl® compressible microspheres)

Intervention Type: DEVICE

Embolic material

Interventions

Prostatic Artery Embolization (HydroPearl® compressible microspheres)

Embolic material

Intervention Type: DEVICE

Other Intervention Names

HydroPearl® compressible microspheres (75 to 400 µm)

Eligibility Criteria

Inclusion Criteria

• Male
• Age ≥ 40
• Prostate gland measures ≥50 grams measured by MRI, CT, or ultrasound
• Have previously taken BPH medications including either alpha blockers, 5-alpha reductase inhibitors or the combination of both for 6 months
• Capable of giving informed consent
• Life expectancy greater than 1 year

Exclusion Criteria

• Severe vascular disease as defined by severe arterial calcification seen on prior imaging, history of lower extremity or pelvic bypass grafts or history of lower extremity or pelvic arterial stenting. For patients that do not have prior imaging at UNC, we will rule out suspected severe arterial calcification given their medical history.
• Uncontrolled diabetes mellitus which is defined as Hemoglobin A1C >8%
• Patients currently taking SGLT2 inhibitors (cana-, dapa-, empa-, and ertu- gliflozin) due to their diuretic effects
• A smoking history of 20 pack-year or greater obtained by patient report
• Prior myocardial infarction
• A stroke within the last 6 months
• Unstable angina
• Immunosuppression
• Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
• Complete urinary retention
• Impaired kidney function (serum creatinine level > 1.8 mg/dl or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
• Confirmed or suspected bladder cancer as assessed based on patients' medical history or current hematuria
• Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
• Ongoing urogenital infection. For patients with symptoms of a urogenital infection (dysuria, fever, etc.), a urinalysis will be obtained.
• Previous pelvic radiation or radical pelvic surgery
• Confirmed malignancy of the prostate or a history of prostate cancer
• Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Terumo Medical Corporation

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyeon Yu, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-0472

Identifier Type: -

Identifier Source: org_study_id