Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia
Primary Purpose
BPH, Enlarged Prostate (BPH), Prostatic Hyperplasia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prostatic Artery Embolization (HydroPearl® compressible microspheres)
Sponsored by
About this trial
This is an interventional treatment trial for BPH
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 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)
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PAE Procedure
Arm 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)
Outcomes
Primary Outcome Measures
Mean Change in IPSS at 6 Months
The International Prostate Symptom Score (IPSS) is an 8 Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. 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
Mean Change in Quality of Life Scores at 6 Months
The QoL question is a single question included with the IPSS related to the symptoms of the disease benign prostatic hyperplasia (BPH) from 0 to 6. Lower scores indicate a higher quality of life.
Mean Change in Curine Flow
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 Prostate Volume
Change in the prostate size measured in grams (g).
Percent of Prostate Infarcted
Percentage of prostate infarcted will be determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast CT images. Segmentation software will then be employed to calculate the volume.
Incidence of Adverse Events
Percent of patients that experience adverse events following the PAE procedure.
Full Information
NCT ID
NCT04398966
First Posted
May 18, 2020
Last Updated
October 10, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Terumo Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04398966
Brief Title
Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia
Official Title
Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia: Single Subject Study Design
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
The principal investigator is leaving UNC and there is no other faculty to continue the research study.
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
May 8, 2023 (Actual)
Study Completion Date
May 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Terumo Medical Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH, Enlarged Prostate (BPH), Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PAE Procedure
Arm Type
Experimental
Arm 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)
Intervention Type
Device
Intervention Name(s)
Prostatic Artery Embolization (HydroPearl® compressible microspheres)
Other Intervention Name(s)
HydroPearl® compressible microspheres (75 to 400 µm)
Intervention Description
Embolic material
Primary Outcome Measure Information:
Title
Mean Change in IPSS at 6 Months
Description
The International Prostate Symptom Score (IPSS) is an 8 Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. 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).
Time Frame
baseline to 6 months following the procedure
Secondary Outcome Measure Information:
Title
Mean Change in Quality of Life Scores at 6 Months
Description
The QoL question is a single question included with the IPSS related to the symptoms of the disease benign prostatic hyperplasia (BPH) from 0 to 6. Lower scores indicate a higher quality of life.
Time Frame
baseline to 6 months following the procedure
Title
Mean Change in Curine Flow
Description
Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second (mL/s)
Time Frame
Baseline to 6 months following the procedure
Title
Mean Change in Prostate Volume
Description
Change in the prostate size measured in grams (g).
Time Frame
baseline to 6 months following the procedure
Title
Percent of Prostate Infarcted
Description
Percentage of prostate infarcted will be determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast CT images. Segmentation software will then be employed to calculate the volume.
Time Frame
6 months following the procedure
Title
Incidence of Adverse Events
Description
Percent of patients that experience adverse events following the PAE procedure.
Time Frame
up to 3 months following the procedure
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeon Yu, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
9 to 36 months following publication
IPD Sharing 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.
Learn more about this trial
Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia
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