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

Phase 3

Not yet recruiting

• Conditions: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms
• Interventions: Procedure: Prostate Artery Embolization; Procedure: Sham Prostate Artery Embolization

• Registration Number: NCT04807010
• Lead Sponsor: Society of Interventional Radiology Foundation

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-18
• Last Update Submitted: 2021-03-18
• Study First Posted: 2021-03-19
• Last Update Posted: 2021-03-19
• Study Start: 2021-08-01
• Primary Completion: 2023-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham	Sham Prostate Artery Embolization	-
Prostate artery embolization	Prostate Artery Embolization	-
Sham	Prostate Artery Embolization	-

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score	6 months	A survey accessing patient symptomology from BPH induced LUTS

Secondary Outcome Measures

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