Clinical Trial: Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams

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

Official Title: Phase II, Single Center, Single Arm, Open Label Investigation of Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger

Brief Summary: The purpose of the study is to evaluate improvement in symptoms related to benign prostatic hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere Microspheres.

Detailed Summary: The study will evaluate improvement in symptoms associated with benign prostatic hyperplasia (BPH) in men with prostates larger than 90 grams treated with prostate artery embolization (PAE). Symptoms will be assessed utilizing the International Prostate Symptom Score (IPSS) to evaluate change from baseline at 12 months post PAE.
Sponsor: South Florida Medical Imaging, PA

Current Primary Outcome: Improvement of symptoms associated with BPH as assessed by the International Prostate Symptom Score (IPSS) [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in prostate size, as determined by MRI [ Time Frame: 12 months ]
  • Change from baseline in peak urine flow rate (Qmax) determined by urodynamic testing [ Time Frame: 12 Months ]
  • Change from baseline in post void residual volume (PVR) as determined by urodynamic testing [ Time Frame: 12 Months ]
  • Change from baseline in detrusor muscle pressure (Pdet) as determined by urodynamic testing [ Time Frame: 12 Months ]
  • Change from baseline in erectile function as determined by the International Index of Erectile Function (IIEF) [ Time Frame: 12 Months ]
  • Change from baseline in serum prostate specific antigen (PSA) [ Time Frame: 12 Months ]
  • Prostate artery embolization (PSA) related adverse events [ Time Frame: 12 Months ]
  • Overall adverse events [ Time Frame: 12 Months ]
    All adverse events will be assessed for severity, relationship to study treatment, subsequent treatment required, and outcome


Original Secondary Outcome: Same as current

Information By: South Florida Medical Imaging, PA

Dates:
Date Received: March 12, 2015
Date Started: July 2015
Date Completion: November 2023
Last Updated: February 16, 2017
Last Verified: February 2017