Prostate Artery Embolization for the Treatment of Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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The primary study objective is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) at 12 months post prostatic artery embolization (PAE) with bland microspheres.

Detailed Description
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This is a phase 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 BPH in patients with prostate size greater than 40 grams that either refuse surgical treatment or are considered poor candidates for traditional surgical therapy. Two hundred patients will be enrolled in the single treatment arm with follow-up for no less than 12 months. The study will involve a screening period in which patient eligibility will be determined. Once eligibility is confirmed, patients will receive PAE with bland microspheres within 4 weeks of screening baseline imaging. After treatment, patients will return for follow-up visits at 1 month, 3 months, 6 months, and 12 months post PAE. At each of these visits, patients will complete IPSS and IIEF questionnaires, undergo a physical exam, laboratory assessment (including PSA) and perform a medication review. Repeat TRUS and uroflowmetry will be performed at the 3, 6, and 12 month post PAE follow-up visits. MRI or CT will be conducted at the 3 and 12 month visit. Cystoscopy and proctoscopy will be performed if medically indicated. The primary endpoint will be improvement of BPH symptoms as assessed by the IPSS at 12 months post PAE. Patients will continue to be followed according to the institutional standard of care follow-up schedule after they complete the study. Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events and findings on physical examination. Concomitant medication usage will be assessed.

Official Title
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Phase II, Single Arm Prospective Study To Evaluate Safety And Efficacy Of Prostate Artery Embolization In Patients With Lower Urinary Tract Symptoms Due To Benign Prostatic Hyperplasia

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Device: Prostate Embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is aged 50 years or older. Patient has signed informed consent Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment Patient has a prostate size larger than 40g as measured by MRI or CT (if MR not possible) Patient has an IPSS score greater than or equal to 13 Patient either: i. Refuses surgical treatment ii. Is considered high risk for surgical treatment Patient is either: i. Refractory to medical treatment ii. Contraindicated for medical treatment Patient must meet ONE of the following criteria: Baseline PSA ≤ 2.5ng/mL Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA ≥ 25% of total PSA (no biopsy required) Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA < 25% of total PSA AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months Baseline PSA >10 ng/mL AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months Patient has a peak urine flow rate < 12ml/sec. Exclusion Criteria: Active prostatitis or urinary tract infection History of prostate or bladder cancer, or currently being evaluated for cancer Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function. Urethral stricture, bladder neck contracture, other potentially confounding bladder pathology, bladder disease, or confounding urethral pathology Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasomodics within 1 week of study treatment AND has not been on the same drug dosage for 6 months with a stable voiding pattern. Patient has taken antidepressant, anticholinergics, androgens or gonadotropin-releasing hormonal analogues within 2 months of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern. Patient has taken alpha blockers within 4 weeks of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern. Patient has taken 5-alpha reductase inhibitors within 3 months of study treatment AND has not been on the same drug for at least 6 months with a stable voiding pattern History of open prostate surgery, radiofrequency, or microwave therapy Previous open bladder or rectosigmoid colon surgery Acute urinary retention requiring an indwelling catheter Cystolithiasis within the past 3 months Coagulation disturbances not normalized by medical treatment Iodinated contrast allergy not controlled with 24-hour steroid preparation History of pelvic irradiation History of severe peripheral vascular disease or known major iliac arterial occlusive disease Interest in future fertility Significant cardiac or respiratory disease that the Investigator believes puts the patient at risk for a complication during the procedure Acute urinary retention requiring an indwelling catheter Life expectancy less than 6 months History of rectal disease Known immunosuppression either pathological or pharmacological Presence of collateral vessel pathways potentially endangering normal anatomy during embolization that cannot be bypassed with the microcatheter History of any illness or surgery that might confound the results of the study, by producing symptoms which may be confused with those of the disease process under consideration (e.g., Parkinson's, multiple Sclerosis), or which pose an additional risk to the patient.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Prospective Single Center
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate Embolization<br>Prostate Embolization with acrylic polymer microspheres impregnated with porcine gelatin | Device: Prostate Embolization<br>* Embolization of the prostate with acrylic polymer microspheres impregnated with porcine gelatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate improvement of symptoms from benign prostatic hyperplasia | The primary study objective is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) in a whole number score. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prostate specific antigen (PSA) | Change in ng/mL from baseline | 12 months | 
| prostate size | prostate size measured in grams, as determined by TRUS or MRI | 12 months | 
| peak urine flow rate (Qmax) | Change from baseline in as measured in ml/sec | 12 months | 
| post-void residual urine volume (PVR) | ml of urine in the bladder after urination | 12 months | 
| Erectile Function Survey | as measured in 5. Change from baseline in erectile function as assessed by the International Change from baseline in erectile function as assessed by the International Index of Erectile Function (IIEF) in whole numbers | 12 months |