We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02592473
Recruitment Status : Recruiting
First Posted : October 30, 2015
Last Update Posted : November 8, 2017
Sponsor:
Collaborator:
Siemens Medical Solutions
Information provided by (Responsible Party):
Ziv Haskal, MD, University of Virginia

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).

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Benign Prostatic Hyperplasia (BPH) Prostatism Lower Urinary Tract Symptoms (LUTS) Prostatic Hypertrophy Hyperplasia Male Urogenital Diseases Genital Diseases, Male Device: Embozene Microspheres Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prostate Artery Embolization Safety and Efficacy: A Pilot Study
Study Start Date : November 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Embozene Microspheres
Embozene Microspheres are spherical particles consisting of a hydrogel core and a poly nanocoat that will be used during study procedure, Prostatic Artery Embolization (PAE) to reduce or eliminate bloodflow to the prostate.
Device: Embozene Microspheres
Minimally invasive intra-arterial administration of particle embolics into prostate arteries under fluoroscopy and cone-beam CT imaging guidance.



Primary Outcome Measures :
  1. Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 12 months ]
    QMax (peak urinary flow rate) assessment

  2. Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures [ Time Frame: 2 weeks ]
  3. Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 24 months ]
    QMax assessment

  4. Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures [ Time Frame: 24 months ]
  5. Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 12 months ]
    IPSS (International Prostate Symptom Score)

  6. Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 24 months ]
    IPSS

  7. Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 12 months ]
    QoL(quality of life question)

  8. Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 24 months ]
    QoL

  9. Clinical improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 24 months ]
    QMax


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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between ages 45-80 years
  • Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months
  • IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of <12mL/s (milliliters per second) .
  • All prostate volumes will be> 50gm and < 400gm

Exclusion Criteria:

  • Patients with urinary tract infections (> 2/year), prostatitis, or interstitial cystitis
  • Cases of biopsy proven prostate cancer or urethral cancer.
  • Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study.
  • Patients who are classified as New York Heart Association Class III (Moderate), or higher.
  • Patients with history of prior pelvic irradiation.
  • Hypersensitivity reactions to contrast material not manageable with prophylaxis.
  • Patients with serum creatinine values >1.7mg/dl or glomerular filtration rates less than 50.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592473


Contacts
Contact: Amelia R Adelsperger, MS 434-297-5682 ara9f@virginia.edu
Contact: Brigitte J Kelly, BSN RN CCRC 434-297-7136 bjk3c@virginia.edu

Locations
United States, Virginia
University of Virginia Health Systems Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Amelia R Adelsperger, MS    434-297-5682    ara9f@virginia.edu   
Contact: Brigitte J Kelly, BSN RN CCRC    434-297-7136    bjk3c@virginia.edu   
Principal Investigator: Ziv J Haskal, MD         
Sponsors and Collaborators
University of Virginia
Siemens Medical Solutions
Investigators
Principal Investigator: Ziv J Haskal, MD Professor of Radiology

Responsible Party: Ziv Haskal, MD, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT02592473     History of Changes
Other Study ID Numbers: 18236
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Keywords provided by Ziv Haskal, MD, University of Virginia:
Prostate Artery Embolization (PAE)
Benign Prostatic Hyperplasia (BPH)
Lower Urinary Tract Symptoms (LUTS)
BPH
PAE
LUTS
Prostatic Artery Embolization

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Hypertrophy
Lower Urinary Tract Symptoms
Genital Diseases, Male
Prostatism
Pathologic Processes
Prostatic Diseases
Pathological Conditions, Anatomical
Urological Manifestations
Signs and Symptoms