Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia
Trial ID or NCT#
NCT01789840
Status
NOT RECRUITING
Purpose
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).
Official Title
Prospective, Controlled Investigation of Prostate Artery Embolization With Embosphere Microspheres Compared to Transurethral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia
Eligibility Criteria
Ages Eligible for Study: 50 Years to 79 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Patient is age 50 to 79, inclusive2. Patient has signed informed consent3. Patient has had lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study treatment4. Patient has a baseline IPSS Score \> 13 at baseline5. Patient has a prostate size of at least 50 grams and not more than 90 grams, measured by MRI6. Patient has BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused7. Patient must be a candidate for TURP8. 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 infection2. 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 study3. 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 condition5. 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 necessary6. 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 pattern7. 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 pattern8. 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 prostate9. 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 treatment11. 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 lobes13. Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months14. Baseline serum creatinine level \> 1.8 mg/dl15. Known upper tract renal disease16. Cystolithiasis or chronic hematuria within 3 months prior to study treatment17. Active prostatitis18. Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease19. History of pelvic irradiation or radical pelvic surgery20. Patient is interested in future fertility21. Coagulation disturbances not normalized by medical treatment22. Acute urinary retention requiring an indwelling catheter23. Known major iliac arterial occlusive disease24. Allergy to iodinated contrast agents25. Hypersensitivity to gelatin products
Investigator(s)
Harcharan Gill
Urologic oncologist,
Urologist,
Genitourinary specialist,
Urologic surgeon
Kathryn Simmons Stamey Professor, Emeritus
David Hovsepian, MD
Interventional radiologist,
Radiologist
Clinical Professor, Radiology - Pediatric Radiology
Contact us to find out if this trial is right for you.
Contact
Denise Haas
650-736-1252
View on ClinicalTrials.gov
