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

NCT04807010 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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

Keywords

Prostate artery embolization; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Quality of Life

Outcome Measures

Primary Outcomes (1)

• International Prostate Symptom Score

  A survey accessing patient symptomology from BPH induced LUTS

  6 months

Secondary Outcomes (11)

• International Prostate Symptom Score

  1, 3, 6, 9, 12, 24, 36 months

• Quality of Life

  1, 3, 6, 9, 12, 24, 36 months

• Maximal urinary flow rate change from baseline

  6, 12, 24, and 36 months

• Post void residual change from baseline

  6, 12, 24, and 36 months

• International Index of Erectile Function questionnaire (IIEF)

  1, 3, 6, 9, 12, 24, 36 months

Study Arms (2)

Prostate artery embolization

ACTIVE COMPARATOR

Procedure: Prostate Artery Embolization

Sham

SHAM COMPARATOR

Procedure: Prostate Artery Embolization; Procedure: Sham Prostate Artery Embolization

Interventions

Prostate Artery Embolization PROCEDURE

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

Prostate artery embolization; Sham

Sham Prostate Artery Embolization PROCEDURE

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

Sham

Eligibility Criteria

• Age: 45 Years - 90 Years
• Gender Eligibility Details: Patients must be male, as they are the only ones who suffer from BPH induced LUTS
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Society of Interventional Radiology Foundation: lead

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shamar Young, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Jafar Golzarian, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pooja Doshi

CONTACT

703-460-5580; pdoshi@sirweb.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and those recording response will be blinded to cohort allocation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 19, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2023
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 19, 2021

Record last verified: 2021-03