Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia

Inclusion Criteria:

1. Patient is age 50 to 79, inclusive

2. Patient has signed informed consent

3. Patient has had lower urinary tract symptoms (LUTS) secondary to BPH for at least 6
months prior to study treatment

4. Patient has a baseline IPSS Score > 13 at baseline

5. Patient has a prostate size of at least 50 grams and not more than 90 grams, measured
by MRI

6. Patient has BPH symptoms refractory to medical treatment or for whom medication is
contraindicated, not tolerated or refused

7. Patient must be a candidate for TURP

8. Patient must meet ONE of the following criteria:

- Baseline Prostate Specific Antigen (PSA) <2.5 ng/mL (no prostate biopsy required)

- Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA > 25% of total PSA (no
prostate biopsy required)

- Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA < 25% of total PSA AND a
negative prostate biopsy result (minimum 12 core biopsy)

- Baseline PSA >10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)

Exclusion Criteria:

1. Active urinary tract infection

2. Biopsy proven prostate or bladder cancer, or any cancer other than basal or squamous
cell skin cancer

- The following patients must undergo prostate biopsy with a minimum of 12 cores
and have a negative histopathology report to be enrolled in the study:

- Patients with digital rectal examination (DRE) findings suspicious for
prostate cancer

- Patients with baseline PSA levels > 10 ng/mL

- Patients with baseline PSA levels >2.5 ng/mL and < 10ng/mL AND free PSA <
25% of total PSA

- Patients with cystoscopy findings suspicious for bladder cancer must undergo
biopsy and have a negative histopathology report to be enrolled in the study

3. Bladder atonia, neurogenic bladder disorder or other neurological disorder that is
impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord
injuries, etc)

4. Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary
obstruction due to causes other than BPH, or other potentially confounding bladder or
urethral disease or condition

5. Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasmodics
within 1 week of study treatment AND has not been on the same drug dosage for 6 months
with a stable voiding pattern

• Dosage of these medications should not change during study participation unless
medically necessary

6. Patient has taken antidepressants, 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 5-alpha reductase inhibitors or alpha blockers within 1 month of
study treatment AND has not been on the same drug dosage for at least 3 months with a
stable voiding pattern

8. Previous non-medical BPH treatment, including surgery, TURP, needle ablation,
microwave or laser therapy, balloon dilation, stent implantation, or any other
invasive treatment to the prostate

9. Any known condition that limits catheter-based intervention or is a contraindication
to embolization, such as intolerance to a vessel occlusion procedure or severe
atherosclerosis.

10. Patient is unable to stop taking anticoagulant, nonsteroidal antiinflammatory drug
(NSAID) or anti-platelet therapy for 7 days prior to study treatment

11. Unable to have MRI imaging (eg metal implant including pacemaker, replacement joint,
etc)

12. Patient has an asymmetric prostate, with > 20% difference in size between lobes

13. Cardiac condition including congestive heart failure or arrhythmia, uncontrolled
diabetes mellitus, significant respiratory disease or known immunosuppression which
required hospitalization within the previous 6 months

14. Baseline serum creatinine level > 1.8 mg/dl

15. Known upper tract renal disease

16. Cystolithiasis or chronic hematuria within 3 months prior to study treatment

17. Active prostatitis

18. Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease

19. History of pelvic irradiation or radical pelvic surgery

20. Patient is interested in future fertility

21. Coagulation disturbances not normalized by medical treatment

22. Acute urinary retention requiring an indwelling catheter

23. Known major iliac arterial occlusive disease

24. Allergy to iodinated contrast agents

25. Hypersensitivity to gelatin products