Clinical Trial: Prostate Embolization for Benign Prostatic Hyperplasia

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

Official Title: Prostate Embolization for Benign Prostatic Hyperplasia

Brief Summary: This is a Phase I/II investigator sponsored FDA-approved Investigational Device Exemption protocol, with the primary goal of determining the safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia. Our primary goal is to document the frequency of side effects, particularly bladder and rectal complications, which may occur as a result of this procedure. Secondarily, the study will provide preliminary data to determine its effectiveness in diminishing obstructive symptoms associated with BPH.

Detailed Summary:

Objectives of the investigation

This study has a primary goal of determining the safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia. Our primary outcome is the frequency of adverse events, particularly bladder and rectal complications, which may occur as a result of this procedure. Secondarily, the study will allow us to begin to determine its effectiveness in diminishing obstructive symptoms associated with BPH.

Duration of investigation

The investigation will enroll 30 patients, with a target enrollment period of less than 12 months. Each patient will be consented for follow-up up to 5 years, but each patient will reach the first important safety endpoint 1 week after treatment and the first clinical efficacy assessment 3 months after treatment.

Objectives

To determine the safety and effectiveness of prostate artery embolization for the treatment of BPH.

Description of study type

This is a prospective observational non-comparative study of an initial cohort of 30 patients.

Study Population

The patients will be recruited from the urology practice at Georgetown University and from other urologists in the area and by patient self-referral. The study also will be announced on a study website, the content of which will be approved by the IRB at Georgetown University Medical Center.

The primary outcome is the absence of complications to the bladder, rectum or other pelvic structures detected in the first we
Sponsor: James B. Spies, MD

Current Primary Outcome:

  • Evidence of bladder or rectal ischemic injury [ Time Frame: Evaluated 1 week after procedure ]

    This will be done by cystoscopy done in an office setting. During this evaluation a small thin scope will be passed through the urethra into the bladder to evaluate its' lining. Also, a digital rectal exam will be completed, along with inspection of the rectum with a small scope.

    Each will be categorized as to type and severity using the Society of Interventional Radiology (SIR) definitions of adverse events based on outcome.

  • Detection of bladder or rectal ischemic injury [ Time Frame: 3 months after treatment ]
    This will be done by cystoscopy done in an office setting. During this evaluation a small thin scope will be passed through the urethra into the bladder to evaluate its' lining. Also, a digital rectal exam will be completed, along with inspection of the rectum with a small scope.
  • Detection of a bladder or rectal ischemic injury [ Time Frame: 6 months after treatment ]
    This will be done by cystoscopy done in an office setting. During this evaluation a small thin scope will be passed through the urethra into the bladder to evaluate its' lining. Also, a digital rectal exam will be completed, along with inspection of the rectum with a small scope.
  • Detection of a bladder or rectal ischemic injury [ Time Frame: 12 months after the procedure ]
    This will be done by cystoscopy done in an office setting. During this eval

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Improvement in the International Prostate Symptom Score (IPSS) [ Time Frame: Evaluated at 3 months, 6 months, 12 months and then annually for 5 years after treatment. ]
      Improvement in the International Prostate Symptom Score (IPSS), a validated and well-accepted symptom and quality of life questionnaire.
    • Improvement in the International Index of Erectile Function (IIEF-5) [ Time Frame: Evaluated at 3 months, 6 months, 12 months and then annually for 5 years after treatment. ]
      Improvement in the International Index of Erectile Function (IIEF-5), a validated questionnaire to assess erectile function.
    • Improvement in Uroflowmetry post embolization [ Time Frame: Evaluated at 3 months, 6 months, 12 months and then annually for 5 years after treatment. ]
      Urine flowmetry includes voided volume, total time of voiding, peak urine flow rate (Qmax), average urine flow rate, and post void urinary volume
    • Prostate volume compared to a pre and post embolization [ Time Frame: Evaluated prior to treatment and at 3 months, 6 months, 12 months and then annually for 5 years after treatment. ]
      Prostate volume compared to a pre and post embolization as determined by measurements of the gland using MRI, or trans-rectal ultrasound if MRI cannot be completed.
    • Serum PSA [ Time Frame: Evaluated prior to treatment and at 3 months, 6 months, 12 months and then annually for 5 years after treatment. ]
    • Post-procedure pain [ Time Frame: Assessed 24 hours after treatment, prior to discharge ]
      Post procedural pain as measured on a visual analogue scale (VAS).
    • Procedure time and radiation parameters [ Time Frame: Recorded immediately after procedure ]
      Procedure time and radiation parameters (fluoroscopy time, dose area product, cumulative dose).
    • Percentage of prostate tissue devascularized, based on contrast-enhanced MRI. [ Time Frame: Evaluated prior to treatment and at 3 months, 6 months, 12 months and then annually for 5 years after treatment. ]
      This is done by estimating the prostate volume and the estimated portion that is non-perfused on each MRI study.


    Original Secondary Outcome: Same as current

    Information By: Georgetown University

    Dates:
    Date Received: August 14, 2013
    Date Started: August 2013
    Date Completion: January 2019
    Last Updated: July 28, 2016
    Last Verified: July 2016