Investigator-initiated study to evaluate the safety and efficacy of prostate artery embolization for the treatment lower urinary tract symptoms in patients with 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