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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia
• Intervention / Treatment: Procedure: Prostate Artery Embolization; Procedure: Sham Prostate Artery Embolization

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pooja Doshi; Phone Number: 580 703-460-5580; Email: pdoshi@sirweb.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Society of Interventional Radiology Foundation
• Investigators: Principal Investigator: Shamar Young, MD, University of Minnesota; Principal Investigator: Jafar Golzarian, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2026

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Prostate artery embolization
• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: 001 (NavyGHB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No