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

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring BPH, Prostate, Prostatic Hyperplasia, enlarged prostate, LUTS, urinary retention Read More

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