Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia

NCT04398966 | Terminated Results FDA Device

• 1 other identifier: 20-0472
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

BPH; Enlarged Prostate (BPH); Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Mean Change in IPSS at 6 Months

  The International Prostate Symptom Score (IPSS) includes 7 Likert-type questions related to symptoms with scores ranging from 0 to 5, where 0 is less severe. The IPSS is a written screening tool used to: screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35).

  baseline to 6 months following the procedure

Secondary Outcomes (6)

• Mean Change in Quality of Life Scores at 6 Months

  baseline to 6 months following the procedure

• Mean Change in Urine Flow

  Baseline to 6 months following the procedure

• Mean Change in Prostate Volume

  baseline to 6 months following the procedure

• Mean Percent of Prostate Infarcted

  6 months following the procedure

• Incidence of Treatment Related Adverse Events (Proportion)

  up to 3 months following the procedure

Study Arms (1)

PAE Procedure

EXPERIMENTAL

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)

Device: Prostatic Artery Embolization (HydroPearl® compressible microspheres)

Interventions

Prostatic Artery Embolization (HydroPearl® compressible microspheres) DEVICE

Embolic material

Also known as: HydroPearl® compressible microspheres (75 to 400 µm)

PAE Procedure

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Terumo Medical Corporation: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Markeela Lipscomb
• Organization: University of North Carolina at Chapel Hill

markeela_lipscomb@med.unc.edu

919-843-3670

Study Officials

• Hyeon Yu, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 22, 2020
• Study Start: September 23, 2020
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: May 7, 2024
• Results First Posted: April 3, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

US (1)