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

Study Overview
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Brief Summary
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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.

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

Conditions
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Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Procedure: Prostate Artery Embolization
* Procedure: Sham Prostate Artery Embolization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prostate artery embolization<br> | Procedure: Prostate Artery Embolization<br>* Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries.<br>|
| Sham Comparator: Sham<br> | Procedure: Prostate Artery Embolization<br>* Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries.<br>Procedure: Sham Prostate Artery Embolization<br>* Angiogram without embolization initially. At 6 months patients will be allowed to crossover to prostate artery embolization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score | A survey accessing patient symptomology from BPH induced LUTS | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score | A survey accessing patient symptomology from BPH induced LUTS | 1, 3, 6, 9, 12, 24, 36 months | 
| Quality of Life | A survey accessing quality of life impact on patients from BPH induced LUTS. | 1, 3, 6, 9, 12, 24, 36 months | 
| Maximal urinary flow rate change from baseline | Maximal flow rate of urine stream | 6, 12, 24, and 36 months | 
| Post void residual change from baseline | Post void residual measures the volume of urine remaining in the bladder after complete emptying. | 6, 12, 24, and 36 months | 
| International Index of Erectile Function questionnaire (IIEF) | A questionnaire designed to asses erectile function | 1, 3, 6, 9, 12, 24, 36 months | 
| Freedom from secondary intervention to treat BPH | Recording of other surgical/procedural treatments with each procedure being recorded as an event. | 1, 3, 6, 9, 12, 24, 36 months | 
| Ejaculatory function | Ejaculatory function will be assessed utilizing a four item questionnaire. | 3, 6, 9, 12, 24, 36 months | 
| Urinary Continence | Urinary Continence will be assessed using a 2 item questionnaire | 1, 6, and 12 months | 
| Number of hospital days | Number of hospital days following the procedure will be recorded | 1 month | 
| Recover experience | Recover experience will be assessed using a quality of recovery visual analog scale | 1 month | 
| Adverse events | All procedure related adverse events will be recoreded | 7 days and 1, 3, 6, 9, 12, 24, 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate artery embolization, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Quality of Life