Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia

Not Applicable

Terminated

• Conditions: Prostatic Hyperplasia; BPH; Enlarged Prostate (BPH)
• Interventions: Device: Prostatic Artery Embolization (HydroPearl® compressible microspheres)

• Registration Number: NCT04398966
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-22
• Study Start: 2020-09-23
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Status Verified: 2023-10
• Results First Submitted: 2024-03-08
• Results First Submitted QC: 2024-03-08
• Results First Posted: 2024-04-03
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 12

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PAE Procedure	Prostatic Artery Embolization (HydroPearl® compressible microspheres)	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)

Primary Outcome Measures

Name	Time	Method
Mean Change in IPSS at 6 Months	baseline to 6 months following the procedure	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).

Secondary Outcome Measures

Name	Time	Method
Mean Change in Urine Flow	Baseline to 6 months following the procedure	Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second (mL/s)
Mean Change in Quality of Life Scores at 6 Months	baseline to 6 months following the procedure	The QoL question of the International Prostate Symptom Score (IPSS) is a single question related to the symptoms of the disease benign prostatic hyperplasia (BPH) and ranges from 0 to 6. Lower scores indicate a higher quality of life.
Mean Change in Prostate Volume	baseline to 6 months following the procedure	Change in the prostate size measured in grams (g).
Mean Percent of Prostate Infarcted	6 months following the procedure	Individual percentage of prostate infarcted determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast MRI images and data aggregated for the group to report mean percent.
Incidence of Treatment Related Adverse Events (Proportion)	up to 3 months following the procedure	Proportion of participants that experience adverse events considered related to the PAE procedure.
Incidence of Treatment Related Adverse Events (Percent)	up to 3 months following the procedure	Percent of participants that experience adverse events considered related to the PAE procedure.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States