search
Back to results

PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia (PROARTE)

Primary Purpose

Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Prostate Artery Embolization
Sham Prostate Artery Embolization
Sponsored by
Society of Interventional Radiology Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Prostate artery embolization, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Quality of Life

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • • Men ≥45 and ≤90 years presenting with benign prostatic hyperplasia with symptoms for at least 6 months that are refractory to medical management or in whom medications are contraindicated, not tolerated, or refused.

    • International Prostate Symptom Score (I-PSS) score 14 or greater.
    • Quality of Life (QoL) score ≥ 3
    • Peak urinary flow (Qmax) less than or equal to 12 mL/s with void volume >125mL.
    • Prostate volume greater than 30 cc as determined by ultrasound, MRI, or CT.
    • Personal risk <40% based on the University of Texas San Antonio prostate cancer risk calculator or having a negative prostate biopsy for cancer within the last 24 months.
    • Able to provide written consent.
    • Not participating in any other investigational drug or device studies.

Exclusion Criteria:

  • • History of biopsy-proven prostate cancer

    • Renal insufficiency (glomerular filtration rates (GFR) less than 40mL/min/1.73 m2 who are not already on dialysis)
    • Prior prostate surgery or intervention, including trans-urethral resection of the prostate, balloon dilation, stent implantation, laser prostatectomy, radiation, UroLift®, or hyperthermia
    • Other bladder or urethral pathology requiring therapy, either in the past or currently, including neurogenic bladder, sphincteric abnormalities, bladder cancer, or other causes of bladder atonia.
    • Other causes of urinary obstruction, such as strictures of urethra or ureters, not related to BPH
    • Current decompensated congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression.
    • Neurological disease, including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, and previous spinal nerve surgery
    • Patients with platelet count <50,000/μL or International Normalized Ratio (INR) >1.8, unless corrected for the procedure
    • Active urinary tract infection. Patients must have a negative culture within 7 days of the procedure.
    • Allergy to iodinated contrast agents unless pre-treated by corticosteroids.
    • Acute urinary retention.
    • Post void residual (PVR) > 250 mL with urodynamic evidence of atonic bladder. Patients with a PVR >250 but urodynamic testing consistent with obstruction will be allowed.
    • Bladder stone within three months prior to the procedure.
    • Hematuria not evaluated by Urologist for causes other than BPH.
    • Previous rectal surgery (excluding hemorrhoidectomy) or history of rectal disease.
    • Prior pelvic irradiation or radical pelvic surgery.

Imaging exclusion criteria:

• Internal iliac artery occlusion as determined by either CT or MRI.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Prostate artery embolization

    Sham

    Arm Description

    Outcomes

    Primary Outcome Measures

    International Prostate Symptom Score
    A survey accessing patient symptomology from BPH induced LUTS

    Secondary Outcome Measures

    International Prostate Symptom Score
    A survey accessing patient symptomology from BPH induced LUTS
    Quality of Life
    A survey accessing quality of life impact on patients from BPH induced LUTS.
    Maximal urinary flow rate change from baseline
    Maximal flow rate of urine stream
    Post void residual change from baseline
    Post void residual measures the volume of urine remaining in the bladder after complete emptying.
    International Index of Erectile Function questionnaire (IIEF)
    A questionnaire designed to asses erectile function
    Freedom from secondary intervention to treat BPH
    Recording of other surgical/procedural treatments with each procedure being recorded as an event.
    Ejaculatory function
    Ejaculatory function will be assessed utilizing a four item questionnaire.
    Urinary Continence
    Urinary Continence will be assessed using a 2 item questionnaire
    Number of hospital days
    Number of hospital days following the procedure will be recorded
    Recover experience
    Recover experience will be assessed using a quality of recovery visual analog scale
    Adverse events
    All procedure related adverse events will be recoreded

    Full Information

    First Posted
    March 11, 2021
    Last Updated
    March 18, 2021
    Sponsor
    Society of Interventional Radiology Foundation
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04807010
    Brief Title
    PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia
    Acronym
    PROARTE
    Official Title
    PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2021 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    August 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Society of Interventional Radiology Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a trial to demonstrate the superiority of prostate artery embolization (PAE) over sham procedure in men with benign prostatic hyperplasia (BPH) induced lower urinary tract symptoms (LUTS). The trial will aim to enroll 108 patients at a 2:1 allocation over a 2 year period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
    Keywords
    Prostate artery embolization, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Quality of Life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Patients and those recording response will be blinded to cohort allocation.
    Allocation
    Randomized
    Enrollment
    108 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prostate artery embolization
    Arm Type
    Active Comparator
    Arm Title
    Sham
    Arm Type
    Sham Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Prostate Artery Embolization
    Intervention Description
    Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries.
    Intervention Type
    Procedure
    Intervention Name(s)
    Sham Prostate Artery Embolization
    Intervention Description
    Angiogram without embolization initially. At 6 months patients will be allowed to crossover to prostate artery embolization.
    Primary Outcome Measure Information:
    Title
    International Prostate Symptom Score
    Description
    A survey accessing patient symptomology from BPH induced LUTS
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    International Prostate Symptom Score
    Description
    A survey accessing patient symptomology from BPH induced LUTS
    Time Frame
    1, 3, 6, 9, 12, 24, 36 months
    Title
    Quality of Life
    Description
    A survey accessing quality of life impact on patients from BPH induced LUTS.
    Time Frame
    1, 3, 6, 9, 12, 24, 36 months
    Title
    Maximal urinary flow rate change from baseline
    Description
    Maximal flow rate of urine stream
    Time Frame
    6, 12, 24, and 36 months
    Title
    Post void residual change from baseline
    Description
    Post void residual measures the volume of urine remaining in the bladder after complete emptying.
    Time Frame
    6, 12, 24, and 36 months
    Title
    International Index of Erectile Function questionnaire (IIEF)
    Description
    A questionnaire designed to asses erectile function
    Time Frame
    1, 3, 6, 9, 12, 24, 36 months
    Title
    Freedom from secondary intervention to treat BPH
    Description
    Recording of other surgical/procedural treatments with each procedure being recorded as an event.
    Time Frame
    1, 3, 6, 9, 12, 24, 36 months
    Title
    Ejaculatory function
    Description
    Ejaculatory function will be assessed utilizing a four item questionnaire.
    Time Frame
    3, 6, 9, 12, 24, 36 months
    Title
    Urinary Continence
    Description
    Urinary Continence will be assessed using a 2 item questionnaire
    Time Frame
    1, 6, and 12 months
    Title
    Number of hospital days
    Description
    Number of hospital days following the procedure will be recorded
    Time Frame
    1 month
    Title
    Recover experience
    Description
    Recover experience will be assessed using a quality of recovery visual analog scale
    Time Frame
    1 month
    Title
    Adverse events
    Description
    All procedure related adverse events will be recoreded
    Time Frame
    7 days and 1, 3, 6, 9, 12, 24, 36 months

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    Patients must be male, as they are the only ones who suffer from BPH induced LUTS
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • Men ≥45 and ≤90 years presenting with benign prostatic hyperplasia with symptoms for at least 6 months that are refractory to medical management or in whom medications are contraindicated, not tolerated, or refused. International Prostate Symptom Score (I-PSS) score 14 or greater. Quality of Life (QoL) score ≥ 3 Peak urinary flow (Qmax) less than or equal to 12 mL/s with void volume >125mL. Prostate volume greater than 30 cc as determined by ultrasound, MRI, or CT. Personal risk <40% based on the University of Texas San Antonio prostate cancer risk calculator or having a negative prostate biopsy for cancer within the last 24 months. Able to provide written consent. Not participating in any other investigational drug or device studies. Exclusion Criteria: • History of biopsy-proven prostate cancer Renal insufficiency (glomerular filtration rates (GFR) less than 40mL/min/1.73 m2 who are not already on dialysis) Prior prostate surgery or intervention, including trans-urethral resection of the prostate, balloon dilation, stent implantation, laser prostatectomy, radiation, UroLift®, or hyperthermia Other bladder or urethral pathology requiring therapy, either in the past or currently, including neurogenic bladder, sphincteric abnormalities, bladder cancer, or other causes of bladder atonia. Other causes of urinary obstruction, such as strictures of urethra or ureters, not related to BPH Current decompensated congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression. Neurological disease, including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, and previous spinal nerve surgery Patients with platelet count <50,000/μL or International Normalized Ratio (INR) >1.8, unless corrected for the procedure Active urinary tract infection. Patients must have a negative culture within 7 days of the procedure. Allergy to iodinated contrast agents unless pre-treated by corticosteroids. Acute urinary retention. Post void residual (PVR) > 250 mL with urodynamic evidence of atonic bladder. Patients with a PVR >250 but urodynamic testing consistent with obstruction will be allowed. Bladder stone within three months prior to the procedure. Hematuria not evaluated by Urologist for causes other than BPH. Previous rectal surgery (excluding hemorrhoidectomy) or history of rectal disease. Prior pelvic irradiation or radical pelvic surgery. Imaging exclusion criteria: • Internal iliac artery occlusion as determined by either CT or MRI.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pooja Doshi
    Phone
    703-460-5580
    Ext
    580
    Email
    pdoshi@sirweb.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shamar Young, MD
    Organizational Affiliation
    University of Minnesota
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jafar Golzarian, MD
    Organizational Affiliation
    University of Minnesota
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia

    We'll reach out to this number within 24 hrs