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Analysis of Prostatic Arterial Embolization for Benign Prostatic Hyperplasia Using Embosphere Microspheres

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ClinicalTrials.gov Identifier: NCT02679430
Recruitment Status : Not yet recruiting
First Posted : February 10, 2016
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Sergei Sobolevsky, Maimonides Medical Center

Brief Summary:
Investigators hypothesis that arterial embolization of men with symptomatic BPH, analogous to uterine fibroid embolization for women, is safe and effective.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: Prostate Arterial Embolization Not Applicable

Detailed Description:

The purpose of this study is to demonstrate the safety and efficacy of the device, Embosphere Microspheres, in prostatic arterial embolization (PAE). PAE, is now an accepted form of treatment for BPH outside of the United States, however few studies have been performed demonstrating safety and efficacy in the US. Embosphere Microsphere is a device that may be used to reduce blood flow to targeted organs. With this research, we would like to show that Embosphere Microsphere may be used for patients with benign hyperplasia of prostate (BPH to reduce blood flow to the prostate gland. This current study is designed to understand the rate of improved BPH symptoms.

Patients with moderate to severe lower urinary tract symptoms resulting from BPH are eligible for this study. Specifically, patients that have been on conservative medical therapy for at least 6 months with no relief of symptoms are being asked to participate in this trial. Patients meeting this criterion would traditionally be considered for more invasive treatment options such as surgery. We believe that PAE is an acceptable alternative to the more invasive treatment options currently the standard of care (available) and therefore we are asking you to participate in this study. We would like to demonstrate that PAE utilizing Embosphere Microsphere will improve their symptoms.

The gold standard of treatment for BPH is transurethral resection of the prostate (TURP). It is very effective but is also an invasive open surgical procedure that carries a high risk of sexual dysfunction and incontinence as side effects of the procedure. It is the goal of this study to demonstrate that these complications are not associated with PAE and that PAE will improve symptoms associated with BPH.

Embosphere Microspheres are small biocompatible plastic spheres that are released inside a vessel under x-ray control. Once inside the vessel, the spheres will block the vessel and decrease blood flow to the tissue supplied by that vessel. Embosphere Microspheres have been cleared by the Food and Drug Administration (FDA) for use in the embolization of blood vessels supplying uterine fibroids and vascular tumors. Additionally, they are approved in the European Union for treatment of BPH. This study has been approved by the FDA to use Embosphere Microspheres for research purposes in the treatment of BPH.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Analysis of Prostatic Arterial Embolization
Study Start Date : May 2017
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Prostate Arterial Embolization

Intervention: Patients will undergo prostatic artery embolization.

The purpose of this study is to demonstrate the safety and efficacy of the device, Embosphere Microspheres, in prostatic arterial embolization (PAE). PAE, is now an accepted form of treatment for BPH outside of the United States, however few studies have been performed demonstrating safety and efficacy in the US. Embosphere Microsphere is a device that may be used to reduce blood flow to targeted organs. With this research, we would like to show that Embosphere Microsphere may be used for patients with benign hyperplasia of prostate (BPH to reduce blood flow to the prostate gland. This current study is designed to understand the rate of improved BPH symptoms.

Device: Prostate Arterial Embolization
The purpose of this study is to demonstrate the safety and efficacy of the device, Embosphere Microspheres, in prostatic arterial embolization (PAE). PAE, is now an accepted form of treatment for BPH outside of the United States, however few studies have been performed demonstrating safety and efficacy in the US. Embosphere Microsphere is a device that may be used to reduce blood flow to targeted organs. With this research, we would like to show that Embosphere Microsphere may be used for patients with benign hyperplasia of prostate (BPH to reduce blood flow to the prostate gland. This current study is designed to understand the rate of improved BPH symptoms.



Primary Outcome Measures :
  1. International Prostate Symptom Score (IPSS) [ Time Frame: 12 months ]


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Ages Eligible for Study:   35 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males with the clinical diagnosis of BPH.
  2. IPSS >18 with symptoms that are refractory to medical treatment with combination therapy (alpha-blocker + 5-alpha-reductase-inhibitor (5-ARI), as tolerated by the patient) for a minimum of six months.
  3. Candidates for Transurethral resection of the prostate (TURP), open prostatectomy, Transurethral Needle Ablation (TUNA), or other procedures such as thermal ablation.
  4. Patients are candidates for above procedures, however comorbid conditions present a prohibitive surgical risk.

Exclusion Criteria:

  1. Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology.
  2. Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
  3. Uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression
  4. Severe allergy to iodine contrast and unable to be pre-medicated.
  5. Allergy to gelatin containing products.
  6. Patient is on anticoagulation or anti-platelet treatment and cannot halt medication for 5 days prior to PAE.
  7. Patient is unable to have a MRI/MRA performed.
  8. Magnetic Resonance Angiogram (MRA) reveals severe aorto-iliac atherosclerotic disease prohibiting intervention.
  9. Compromised renal function determined as serum creatinine level > 1.8 mg/dl, or upper‐tract disease.
  10. Prior diagnosis of any pelvic malignancy including prostate cancer.
  11. Have received prior radiation to the pelvis for any condition.
  12. Have had prior pelvic surgery or non-medical BPH treatment.

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): NCT02679430


Contacts
Contact: Sergei Sobolevsky, MD 718-283-7125 Ssobolevsky@maimonidesmed.org

Locations
United States, New York
Maimonides Medical Center Not yet recruiting
Brooklyn, New York, United States, 11219
Principal Investigator: Sergei Sobolevsky, MD         
Sponsors and Collaborators
Sergei Sobolevsky
Investigators
Principal Investigator: Sergei Sobolevsky, MD Maimonides Medical Center

Responsible Party: Sergei Sobolevsky, Director of Interventional Radiology, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT02679430     History of Changes
Other Study ID Numbers: 12/12/VA02
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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