Prostate Embolization for Benign Prostatic Hyperplasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Georgetown University
Sponsor:
Information provided by (Responsible Party):
James B. Spies, MD, Georgetown University Medical Center
ClinicalTrials.gov Identifier:
NCT01924988
First received: August 14, 2013
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Procedure: Prostatic Embolization
Drug: Embosphere® Microspheres
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prostate Embolization for Benign Prostatic Hyperplasia

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Evidence of bladder or rectal ischemic injury [ Time Frame: Evaluated 1 week after procedure ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • Post-procedure pain [ Time Frame: Assessed 24 hours after treatment, prior to discharge ] [ Designated as safety issue: No ]
    Post procedural pain as measured on a visual analogue scale (VAS).

  • Procedure time and radiation parameters [ Time Frame: Recorded immediately after procedure ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    This is done by estimating the prostate volume and the estimated portion that is non-perfused on each MRI study.


Estimated Enrollment: 30
Study Start Date: August 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prostatic Embolization Procedure: Prostatic Embolization

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 pudental 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.

Drug: Embosphere® Microspheres
Embosphere® Microspheres, Merit Medical, South Jordan, UT

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 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 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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. You must have symptoms from BPH for at least 6 months
  2. Your symptoms must meet the entrance criteria, as determined by a short questionnaire you will be asked to complete.
  3. You must have urinary flow rates that meet entrance criteria, as measured by a simple urination test.
  4. Enlargement of the prostate, as measured by the urologist, with a volume of between 50 and 100 cc.
  5. You must be at least 50 years of age, but not more than 90.

Exclusion Criteria:

  • 1. Prostate Cancer 2. Blockage of major arteries in your pelvis or other arterial abnormalities that prevent embolization or that might increase risks of injury. You will be screened for these conditions if you consent to participate.

    3. Significantly decreased kidney function 4. Prior prostate surgery, whether it has been performed via a scope through the penis or with conventional surgery.

    5. Bladder or urinary conditions other than BPH requiring therapy. You will be screened for these conditions if you consent to participate.

    6. History of cardiac rhythm abnormalities, congestive heart failure, uncontrolled diabetes, significant respiratory disease, or known immunosuppression.

    7. History of clotting disorders. 8. Current medications (use of alpha-blockers within two months, 5-alpha-reductase inhibitors within six months, anti-cholinergics within two months, and beta blockers, antihistamines, anticonvulsants, or antispasmodics within one week of treatment unless you have been on the same drug with a stable urination pattern.

    9. Active urinary tract infection 10. Allergy to iodinated contrast agents, collagen or gelatin products 11. Acute urinary retention that has NOT been treated by a urinary catheter. 12. Significant retained urine after voiding as measured by ultrasound. In this case, significant means more than 250 ml (about 1 cup).

    13. Bladder stones or blood in urine within three months 14. Previous rectal surgery, excluding hemorrhoidectomy (removal of hemorrhoid), or history of rectal disease 15. Prior pelvic irradiation or radical pelvic surgery 16. If you are interested in future fertility 17. Unable to speak and read English.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924988

Locations
United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Angela White    202-444-6825    AMWD@gunet.georgetown.edu   
Principal Investigator: James Spies, MD         
Sponsors and Collaborators
James B. Spies, MD
  More Information

No publications provided

Responsible Party: James B. Spies, MD, Chair, Department of Radiology, Georgetown University Medical Center
ClinicalTrials.gov Identifier: NCT01924988     History of Changes
Other Study ID Numbers: G120110
Study First Received: August 14, 2013
Last Updated: March 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgetown University:
BPH, benign prostatic hyperplasia

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014