Back to results

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)

About this trial

This is an interventional treatment trial for BPH

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

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

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

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

We'll reach out to this number within 24 hrs