Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams

Phase II, Single Center, Single Arm, Open Label Investigation of Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams

The purpose of the study is to evaluate improvement in symptoms related to benign prostatic hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere Microspheres.

The study will evaluate improvement in symptoms associated with benign prostatic hyperplasia (BPH) in men with prostates larger than 90 grams treated with prostate artery embolization (PAE). Symptoms will be assessed utilizing the International Prostate Symptom Score (IPSS) to evaluate change from baseline at 12 months post PAE.

Inclusion Criteria:

• Patient has provided signed informed consent
• Patient is aged greater than or equal to 40 and less than or equal to 89 years of age
• Patient has a prostate size between 90g and 200g, as determined by MRI
• Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment
• Patient has an IPSS score of at least 13 at baseline
• Patient is either: refractory to medical treatment, contraindicated to medical treatment, OR refuses medical treatment
• Patient either: refuses surgical treatment OR is contraindicated for surgical treatment
• Patient meets ONE of the following criteria: baseline PSA < 4.0ng/mL (no prostate biopsy required) OR baseline PSA >/= 4 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy) within the prior 12 months

Exclusion Criteria:

• History of prostate, bladder, or rectal cancer
• History of transurethral resection of the prostate (TURP), open prostate surgery, or radiofrequency or microwave therapies
• History of open bladder, rectosigmoid colon, or other pelvic surgery
• Patient is unwilling to discontinue alpha blockers 1 month after study treatment
• Patient is unwilling to discontinue 5-alph reductase inhibitors 1 month after study treatment
• Neurogenic bladder or other neurologic disorder impacting bladder function such as Parkinson's disease, multiple sclerosis, cerebral vascular accident or diabetes
• Any other confounding bladder or urethral pathology, including urethral stricture, bladder neck contracture, or bladder atonia
• Active prostatitis or urinary tract infection
• Cystolithiasis within the past 3 months
• Serum creatinine > 1.7mg/dL
• Inability to discontinue oral anticoagulant 2-5 days prior to study treatment
• Coagulation disturbances not normalized by medical treatment
• Iodinated contrast allergy that, in the opinion of the Investigator, cannot be adequately premedicated
• Gelatin allergy
• Known severe peripheral vascular disease or major iliac arterial occlusive disease
• Interest in future fertility
• Clinically significant cardiac arrhythmia or other cardiac disease (including congestive heart failure), uncontrolled diabetes mellitus, clinically significant respiratory disease, or known immunosuppression
• Other condition that the Investigator believes puts the patient at risk for a complication during the procedure