Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia
Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia
The purpose of this study is to evaluate improvement of symptoms from benign prostatic
 hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for
 prostatic artery embolization (PAE) using Embosphere Microspheres compared to conventional
 transurethral resection of the prostate (TURP).
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