Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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Investigator-initiated study to evaluate the safety and efficacy of prostate artery embolization for the treatment lower urinary tract symptoms in patients with benign prostatic hyperplasia

Detailed Description
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This is a phase I/II, single center, prospective, single arm, investigational study to evaluate the safety and efficacy of prostate artery embolization (PAE) for treatment of severe lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) in patients that have either failed or are intolerant to medical management. Once eligibility is confirmed, patients will undergo PAE with Embosphere Microspheres. Embolization will consist of a minimally invasive angiogram and treatment of the prostate arteries with the Embosphere particles to reduce blood flow to the prostate. Following treatment, patients will return for follow-up visits at 1, 6, 12, and 24 months post PAE.

Official Title
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Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia

Conditions
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Prostatic Hyperplasia, Benign, Enlarged Prostate With Lower Urinary Tract Symptoms

Intervention / Treatment
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* Device: Embosphere microparticles for prostate artery embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prostate volume between 40 and 300 cm3 Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS) defined as at least one of the following: a. IPSS greater than 18 b. IPSS Quality of Life (QoL) assessment greater than 3 c. Qmax less than 12 mL/sec Refractory or intolerant to medical management Ineligibility for or refusal of surgical management One of the following criteria: a. Baseline prostate specific antigen (PSA) ≤2.5 ng/mL b. Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA ≥25% of total PSA c. Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA <25% of total PSA AND negative 12 core prostate biopsy in the past 12 months d. Baseline PSA >10 ng/mL AND negative 12 core biopsy within the past 12 months. Exclusion Criteria: History of prostate, bladder or rectal malignancy. Biopsy proven urethral cancer. History of rectal disease Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal cord injury, diabetes, etc., as demonstrated on urodynamic testing. Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other than BPH, as demonstrated on urodynamic testing Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm Cystolithiasis within the past three months Baseline serum creatinine greater than 1.8 Evidence of tortuous or atherosclerotic blood vessels Presence of collateral vessel pathways potentially endangering normal territories during embolization that cannot be bypassed with the microcatheter Active urinary tract infection, interstitial cystitis, or prostatitis within the last 5 years Coagulation disturbances not normalized by medical treatment Allergy to iodinated contrast agents not responsive to steroid premedication regimen Previous radical pelvic or rectal surgery, or pelvic irradiation Prior surgical prostate intervention Treatment with beta-blocker, antihistamine, anticonvulsant, or antispasmodic medication within 1 week of treatment UNLESS there has been a stable voiding pattern while medicated with the drug(s) for 6 months Use of prostate active medications, including alpha blockers, anti-cholinergics, androgens, anti-androgens, gonadotropins-releasing hormonal analogs, PDE5-inhibitors, 5-alpha reductase inhibitors within 2 months of intervention, unless the medication is necessary to avoid symptom exacerbation and disability, in this case medication should not be initiated or dose adjusted within 1 month of study enrollment and dose should not be adjusted during the study period Interest in future fertility Mental condition or disorder that interferes with participants' ability to provide written informed consent Current severe or uncontrolled disease (metabolic, hematologic, renal, hepatic, pulmonary, neurologic, cardiac, infectious or gastrointestinal) that in the Investigator's judgment makes the patient unsuitable for trial inclusion due to increased risk of complications Known immunosuppression Life expectancy less than 6 months

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate artery embolization<br>Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles. | Device: Embosphere microparticles for prostate artery embolization<br>* Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | The study protocol was terminated before completion as the device was FDA approved and determined to be safe for the treated patient population. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Prostate Symptom Score (IPSS) | International Prostate Symptom Score change from baseline measured at 1 and 6 months. The IPSS scale grades lower urinary tract symptoms on a scale ranging from 0 (no symptoms) to 35 (severe). Patients answer 7 questions about symptoms they have had in the past month and grade each symptom severity for each question on a scale from 0 (not at all) to 5 (almost always). Change is reported as outcome measure time point minus baseline. A positive value indicates improved symptoms and negative value worsened symptoms. | baseline, 1 month, 6 month | 
| Change in Post-void Residual (PVR) on Ultrasound | PVR (mL) change from baseline measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates less post-void residual and a positive value indicates greater PVR at each outcome time point. | baseline, 1 month, 6 month | 
| Change in Peak Urinary Flow Rate (Qmax) | Change in Qmax measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A positive value indicates improved Qmax and negative value indicates decreased Qmax at each outcome time point. | Baseline, 1 month, 6 month | 
| Change in International Index of Erectile Dysfunction (IIEF) | IIEF score change from baseline measured at 1 and 6 months. International Index of Erectile Function (IIEF) is a scale grading erectile function based on 5 questions. Questions are answered from 1 (low function) to 5 (high function). Total scores range from 5 to 25. A total score of 5-7 is severe erectile dysfunction, 8 to 11 is moderate erectile dysfunction, 12 to 16 is mild to moderate erectile dysfunction, 17 to 21 is mild erectile dysfunction, and 22-25 is no erectile dysfunction. Change is reported as outcome measure time point minus baseline. A positive value indicates improved erectile function and a negative indicates worsened erectile function. | baseline, 1 month, 6 month | 
| Change in Prostate Volume (PV) | Change in prostate volume measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates decreased prostate volume and a positive value indicates increased prostate volume. | baseline, 1 month, 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate artery embolization (PAE), benign prostatic hyperplasia (BPH), lower urinary tract symptoms (LUTS)