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Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04398966
Recruitment Status : Not yet recruiting
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
Sponsor:
Collaborator:
Terumo Medical Corporation
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
BPH Enlarged Prostate (BPH) Prostatic Hyperplasia Device: Prostatic Artery Embolization (HydroPearl® compressible microspheres) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia: Single Subject Study Design
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Device: Prostatic Artery Embolization (HydroPearl® compressible microspheres)
Embolic material
Other Name: HydroPearl® compressible microspheres (75 to 400 µm)




Primary Outcome Measures :
  1. Mean Change in IPSS at 6 Months [ Time Frame: baseline to 6 months following the procedure ]
    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 :
  1. Mean Change in Quality of Life Scores at 6 Months [ Time Frame: baseline to 6 months following the procedure ]
    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.

  2. Mean Change in Curine Flow [ Time Frame: 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)

  3. Mean Change in Prostate Volume [ Time Frame: baseline to 6 months following the procedure ]
    Change in the prostate size measured in grams (g).

  4. Percent of Prostate Infarcted [ Time Frame: 6 months following the procedure ]
    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.

  5. Incidence of Adverse Events [ Time Frame: up to 3 months following the procedure ]
    Percent of patients that experience adverse events following the PAE procedure.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04398966


Contacts
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Contact: Markeela Lipscomb, BS 919-843-3670 markeela_lipscomb@med.unc.edu
Contact: Terry Hartman, MPH,MS,CCRC

Locations
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United States, North Carolina
UNC Hospitals
Chapel Hill, North Carolina, United States, 27599
Contact: Markeela L Lipscomb    984-974-8157    markeela_lipscomb@med.unc.edu   
Contact: Shanah Kirk    919-966-6957    shanah_kirk@med.unc.edu   
Sub-Investigator: Ari Isaacson, MD         
Principal Investigator: Hyeon Yu, MD         
Sub-Investigator: Matthew Raynor, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Terumo Medical Corporation
Investigators
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Principal Investigator: Hyeon Yu, MD University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04398966    
Other Study ID Numbers: 20-0472
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: 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.

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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
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male