Clinical Trial: Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prostate Artery Embolization Safety and Efficacy: A Pilot Study

Brief Summary: The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).

Detailed Summary: This pilot study is a prospective, non-randomized clinical trial assessing the safety and feasibility of prostatic artery embolization. Fifty adult male subjects will be enrolled and treated in this study. Patients who provide informed consent and are deemed eligible for participation will undergo prostatic artery embolization in the Interventional Radiology department at the University of Virginia. After performing an angiogram to identify the prostatic arteries, tiny particles known as Embozene Microspheres will be injected into the prostatic artery. Injecting these particles into the prostatic artery will slow blood flow to the prostate and thus shrinking the size of the prostate. By shrinking the size of the prostate, it is hopeful that it will provide relief of lower urinary tract symptoms due to BPH. Subjects will be followed for 2 years as part of their participation in this study.
Sponsor: University of Virginia

Current Primary Outcome:

  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 12 months ]
    QMax (peak urinary flow rate) assessment
  • Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures [ Time Frame: 2 weeks ]
  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 24 months ]
    QMax assessment
  • Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures [ Time Frame: 24 months ]
  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 12 months ]
    IPSS (International Prostate Symptom Score)
  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 24 months ]
    IPSS
  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 12 months ]
    QoL(quality of life question)
  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 24 months ]
    QoL
  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 24 months ]
    QMax


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Urine flow rate as measured by QMax [ Time Frame: 1 month ]
  • Urine flow rate as measured by QMax [ Time Frame: 24 months ]
  • Post-void residual measured in ml/cc [ Time Frame: 1 month ]
  • Post-void residual measured in ml/cc [ Time Frame: 24 months ]
  • UCLA-PCI-SF (University of California, Los Angeles Prostate Cancer Index Short Form) score [ Time Frame: 1 month ]
  • UCLA-PCI-SF score [ Time Frame: 24 months ]


Original Secondary Outcome: Same as current

Information By: University of Virginia

Dates:
Date Received: October 26, 2015
Date Started: November 2015
Date Completion: November 2017
Last Updated: October 24, 2016
Last Verified: October 2016