Prostate Embolization for Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1/Phase 2

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 description: 
      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 non-comparative treatment 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 week after therapy. Each patient will be judged free of
      these adverse events or not. For those with an adverse event, the complication will be scored
      using the Society of Interventional Radiology (SIR) definitions. Descriptive statistics will
      be used to summarize these events, along with patient demographics and initial clinical
      status.

      Appropriate parametric and non-parametric tests will be used to assess change in laboratory
      measures, urine flowmetry parameters, and scores from the IPSS and IIEF. Changes in prostate
      volumes and the estimated volume of devascularized tissue will be calculated for each patient
      and outcomes from the different embolics will be compared. Appropriate paired parametric and
      non-parametric tests will be used to determine statistical significance. A p value of 0.05
      will be considered statistically significant.
    

Intervention name(s): Prostatic Embolization with Embosphere Micropsheres
Intervention type(s): Device
Intervention description(s): Each patient will have a selective internal iliac arteriogram, and as necessary, an arteriogram of the anterior division of the internal iliac artery performed to identify the prostatic arterial supply. This typically arises from the inferior vesicle artery (also known as the prostatic artery), but may have supply from the superior vesicle, the internal pudendal or obturator branches as well.
The prostatic arteries will be selected using standard micro-catheter technique. Embolization of the prostate will be performed with 300 to 500 um sized TAGM (Embosphere® Microspheres, Merit Medical, South Jordan, UT). The embolization endpoint will be absence of the normal blush of the prostate on post embolization angiography and stasis of flow in the prostate arteries.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BPH, benign prostatic hyperplasia