Prostate Artery Embolization for the Treatment of Benign Prostatic Hyperplasia

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.

Inclusion Criteria:

1. Patient is aged 50 years or older.

2. Patient has signed informed consent

3. Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months
prior to study enrollment

4. Patient has a prostate size larger than 40g as measured by MRI or CT (if MR not
possible)

5. Patient has an IPSS score greater than or equal to 13

6. Patient either:

i. Refuses surgical treatment ii. Is considered high risk for surgical treatment

7. Patient is either:

i. Refractory to medical treatment ii. Contraindicated for medical treatment

8. 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

9. Patient has a peak urine flow rate < 12ml/sec.

Exclusion Criteria:

1. Active prostatitis or urinary tract infection

2. History of prostate or bladder cancer, or currently being evaluated for cancer

3. Bladder atonia, neurogenic bladder disorder or other neurological disorder that is
impacting bladder function.

4. Urethral stricture, bladder neck contracture, other potentially confounding bladder
pathology, bladder disease, or confounding urethral pathology

5. 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.

6. 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.

7. 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.

8. 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

9. History of open prostate surgery, radiofrequency, or microwave therapy

10. Previous open bladder or rectosigmoid colon surgery

11. Acute urinary retention requiring an indwelling catheter

12. Cystolithiasis within the past 3 months

13. Coagulation disturbances not normalized by medical treatment

14. Iodinated contrast allergy not controlled with 24-hour steroid preparation

15. History of pelvic irradiation

16. History of severe peripheral vascular disease or known major iliac arterial occlusive
disease

17. Interest in future fertility

18. Significant cardiac or respiratory disease that the Investigator believes puts the
patient at risk for a complication during the procedure

19. Acute urinary retention requiring an indwelling catheter

20. Life expectancy less than 6 months

21. History of rectal disease

22. Known immunosuppression either pathological or pharmacological

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

24. 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.