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

NCT ID: NCT04807010

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2026-08-01

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.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Prostate artery embolization

Group Type: ACTIVE_COMPARATOR

Prostate Artery Embolization

Intervention Type: PROCEDURE

Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries.

Sham

Group Type: SHAM_COMPARATOR

Prostate Artery Embolization

Intervention Type: PROCEDURE

Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries.

Sham Prostate Artery Embolization

Intervention Type: PROCEDURE

Angiogram without embolization initially. At 6 months patients will be allowed to crossover to prostate artery embolization.

Interventions

Prostate Artery Embolization

Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries.

Intervention Type: PROCEDURE

Sham Prostate Artery Embolization

Angiogram without embolization initially. At 6 months patients will be allowed to crossover to prostate artery embolization.

Intervention Type: PROCEDURE

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.

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Society of Interventional Radiology Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shamar Young, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Jafar Golzarian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Central Contacts

Pooja Doshi

Role: CONTACT

pdoshi@sirweb.org

703-460-5580 ext. 580

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id