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

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

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.

Official Title
-----------------
Prospective Analysis of Prostatic Arterial Embolization

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Device: Prostate Arterial Embolization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males with the clinical diagnosis of BPH. 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. Candidates for Transurethral resection of the prostate (TURP), open prostatectomy, Transurethral Needle Ablation (TUNA), or other procedures such as thermal ablation. Patients are candidates for above procedures, however comorbid conditions present a prohibitive surgical risk. Exclusion Criteria: Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology. Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc. Uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression Severe allergy to iodine contrast and unable to be pre-medicated. Allergy to gelatin containing products. Patient is on anticoagulation or anti-platelet treatment and cannot halt medication for 5 days prior to PAE. Patient is unable to have a MRI/MRA performed. Magnetic Resonance Angiogram (MRA) reveals severe aorto-iliac atherosclerotic disease prohibiting intervention. Compromised renal function determined as serum creatinine level > 1.8 mg/dl, or upper-tract disease. Prior diagnosis of any pelvic malignancy including prostate cancer. Have received prior radiation to the pelvis for any condition. Have had prior pelvic surgery or non-medical BPH treatment.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prostate Arterial Embolization<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) | The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). The questions refer to the following urinary symptoms: Questions Symptom Incomplete emptying Frequency Intermittency Urgency Weak Stream Straining Nocturia Question eight refers to the patient's perceived quality of life. | 12 months |