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

Description

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).

Study Start Date

July 2013

Estimated Completion Date

May 2018

Interventions

  • Procedure: TURP
  • Device: Embosphere Microspheres

Specialties

  • Urology

MeSH Terms

  • Benign Prostatic Hyperplasia
  • TURP
  • prostatic artery embolization

Study ID

Merit Medical Systems, Inc. -- BPH-P3-12-01

Status

Unknown

Trial ID

NCT01789840

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

186

Sponsor

Merit Medical Systems, Inc.

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 80 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 7. Patient has taken 5-alpha reductase inhibitors or alpha blockers within 1 month of study treatment 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 23. Known major iliac arterial occlusive disease 24. Allergy to iodinated contrast agents 25. Hypersensitivity to gelatin products

Gender

Male

Ages

50 Years to 79 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (12)

Study Location Distance Name Phone Email
Montefiore Medical Center - Bronx, New York 40.3 miles None None None
Mount Sinai Medical Center - New York, New York 46.8 miles Lourdes CamposGrundvig RN 212-824-7877 lourdes.campos-grundvig@mountsinai.org
Albany Medical Center - Albany, New York 103.6 miles None None None
Johns Hopkins Medical Center - Baltimore, Maryland 225.2 miles Elizabeth Fabian None efabian2@jhmi.edu
Georgetown University Hospital - Washington, District of Columbia 258.0 miles None None None
Tampa General Hospital - Tampa, Florida 1,058.1 miles Marlene Martin 813-844-5012 marlenecmartin@tgh.org
Holy Cross Hospital - Fort Lauderdale, Florida 1,112.7 miles Cynthia Toot NP None cynthia.toot@holy-cross.com
University of Miami Hospital - Miami, Florida 1,141.0 miles Lia Quezada 305-243-3404 lquezada@med.miami.edu
Miami VA Healthcare System - Miami, Florida 1,141.9 miles Lia Quezada 305-243-3404 lia.quezada@va.gov
Long Beach VA - Long Beach, California 2,495.5 miles Steven Bereta NP 714-456-8148 sbereta@uci.edu
VA Greater Los Angeles Healthcare System - Los Angeles, California 2,500.2 miles Zach Erickson None zachary.erickson@va.gov
Stanford University Medical Center - Stanford, California 2,599.9 miles Denise Haas 650-736-1252 dhaas@stanford.edu

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