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

NCT04807010 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2021-03-19

No results posted yet for this 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.

Conditions

  • Benign Prostatic Hyperplasia
  • Lower Urinary Tract Symptoms

Interventions

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.

Sponsors & Collaborators

  • Society of Interventional Radiology Foundation

    lead OTHER

Principal Investigators

  • Shamar Young, MD · University of Minnesota

  • Jafar Golzarian, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2023-08-01
Completion
2026-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04807010 on ClinicalTrials.gov