Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Embosphere Microspheres
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: Male
Minimum age: 40 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: BPH; prostatic hyperplasia; enlarged prostate; benign prostatic hypertrophy

Summary:

      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.
    

Eligibility criteria:

        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