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
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
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
NCT ID
NCT04807010
First Posted
March 11, 2021
Last Updated
March 18, 2021
Sponsor
Society of Interventional Radiology Foundation
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
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PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia
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