CClinicalTrials.gg
Sign In
Not yet recruitingNCT04807010PROARTEUpdated Mar 19, 2021

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

A Phase 3 interventional study of Prostate Artery Embolization and Sham Prostate Artery Embolization in Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, sponsored by Society of Interventional Radiology Foundation. Not yet recruiting. Open to male participants aged 45 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-03-19.

Sponsored by Society of Interventional Radiology Foundation · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2023, 3 years 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
45 Years to 90 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Benign Prostatic Hyperplasia
  • Lower Urinary Tract Symptoms

Keywords

  • Prostate artery embolization
  • Benign Prostatic Hyperplasia
  • Lower Urinary Tract Symptoms
  • Quality of Life
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's planned enrollment of 108 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

This is the only study on the registry with Society of Interventional Radiology Foundation as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 90 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
108 participants (estimated)

Study arms

  • Active comparator
    Prostate artery embolization

    Procedure: Prostate Artery Embolization

  • Sham comparator
    Sham

    Procedure: Prostate Artery Embolization · Procedure: Sham Prostate Artery Embolization

Interventions

  • ProcedureProstate Artery Embolization

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

  • ProcedureSham Prostate Artery Embolization

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

06

What researchers measure

Primary outcomes

  1. International Prostate Symptom Score

    A survey accessing patient symptomology from BPH induced LUTS

    Time frame: 6 months

Secondary outcomes

  1. International Prostate Symptom Score

    A survey accessing patient symptomology from BPH induced LUTS

    Time frame: 1, 3, 6, 9, 12, 24, 36 months

  2. Quality of Life

    A survey accessing quality of life impact on patients from BPH induced LUTS.

    Time frame: 1, 3, 6, 9, 12, 24, 36 months

  3. Maximal urinary flow rate change from baseline

    Maximal flow rate of urine stream

    Time frame: 6, 12, 24, and 36 months

  4. Post void residual change from baseline

    Post void residual measures the volume of urine remaining in the bladder after complete emptying.

    Time frame: 6, 12, 24, and 36 months

  5. International Index of Erectile Function questionnaire (IIEF)

    A questionnaire designed to asses erectile function

    Time frame: 1, 3, 6, 9, 12, 24, 36 months

  6. Freedom from secondary intervention to treat BPH

    Recording of other surgical/procedural treatments with each procedure being recorded as an event.

    Time frame: 1, 3, 6, 9, 12, 24, 36 months

  7. Ejaculatory function

    Ejaculatory function will be assessed utilizing a four item questionnaire.

    Time frame: 3, 6, 9, 12, 24, 36 months

  8. Urinary Continence

    Urinary Continence will be assessed using a 2 item questionnaire

    Time frame: 1, 6, and 12 months

  9. Number of hospital days

    Number of hospital days following the procedure will be recorded

    Time frame: 1 month

  10. Recover experience

    Recover experience will be assessed using a quality of recovery visual analog scale

    Time frame: 1 month

  11. Adverse events

    All procedure related adverse events will be recoreded

    Time frame: 7 days and 1, 3, 6, 9, 12, 24, 36 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04807010
Lead sponsor
Society of Interventional Radiology Foundation
Responsible party
Sponsor
First posted
Mar 19, 2021
Start date
Aug 1, 2021 (estimated)
Primary completion
Aug 1, 2023 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Mar 19, 2021

Study contacts

Pooja Doshi
Contact
pdoshi@sirweb.org
703-460-5580 ext. 580
Shamar Young, MD
principal investigator · University of Minnesota
Jafar Golzarian, MD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Prostatic Hyperplasia→

Start the discussion