Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia

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.

Inclusion Criteria:

1. Prostate volume between 40 and 300 cm3

2. 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

3. Refractory or intolerant to medical management

4. Ineligibility for or refusal of surgical management

5. 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:

1. History of prostate, bladder or rectal malignancy. Biopsy proven urethral cancer.

2. History of rectal disease

3. Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal
cord injury, diabetes, etc., as demonstrated on urodynamic testing.

4. Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other
than BPH, as demonstrated on urodynamic testing

5. Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm

6. Cystolithiasis within the past three months

7. Baseline serum creatinine greater than 1.8

8. Evidence of tortuous or atherosclerotic blood vessels

9. Presence of collateral vessel pathways potentially endangering normal territories
during embolization that cannot be bypassed with the microcatheter

10. Active urinary tract infection, interstitial cystitis, or prostatitis within the last
5 years

11. Coagulation disturbances not normalized by medical treatment

12. Allergy to iodinated contrast agents not responsive to steroid premedication regimen

13. Previous radical pelvic or rectal surgery, or pelvic irradiation

14. Prior surgical prostate intervention

15. 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

16. 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

17. Interest in future fertility

18. Mental condition or disorder that interferes with participants' ability to provide
written informed consent

19. 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

20. Known immunosuppression

21. Life expectancy less than 6 months