Prostate Artery Embolization for the Treatment of Benign Prostatic Hyperplasia
Prostate Artery Embolization for the Treatment of Benign Prostatic Hyperplasia
The primary study objective is to evaluate improvement of symptoms from benign prostatic
 hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) at 12 months
 post prostatic artery embolization (PAE) with bland microspheres.
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.