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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Merit Medical Systems, Inc.
Sponsor:
Information provided by (Responsible Party):
Merit Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01789840
First received: February 8, 2013
Last updated: September 2, 2014
Last verified: September 2014
  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).


Condition Intervention Phase
Benign Prostatic Hyperplasia
Device: Embosphere Microspheres
Procedure: TURP
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Controlled Investigation of Prostate Artery Embolization With Embosphere Microspheres Compared to Transurethral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia

Resource links provided by NLM:


Further study details as provided by Merit Medical Systems, Inc.:

Primary Outcome Measures:
  • IPSS Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary endpoint will be improvement of symptoms from BPH evaluated using the IPSS at 12 months post procedure.


Secondary Outcome Measures:
  • Duration of hospitalization post procedure [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Duration of post procedure catheterization [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Overall and procedure related adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events, as well as changes in laboratory values, and finding on physical examination.


Other Outcome Measures:
  • Change from baseline in peak urine flow rate (Qmax) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in erectile function using the International Index of Erectile Function (IIEF) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in mean prostate volume, as determine by MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in post-void residual urinary volume (PVR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in detrusor muscle pressure (Pdet) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in baseline from prostate specific antigen (PSA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 186
Study Start Date: July 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prostate artery emoblization (PAE)
Prostate artery embolization using Embosphere Microspheres
Device: Embosphere Microspheres
Other Name: Embosphere Microspheres
Active Comparator: Transurethral resection of the prostate (TURP)
Transurethral Resection of the Prostate (TURP)
Procedure: TURP
Other Name: TURP - Transurethal resection of the prostate

  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789840

Contacts
Contact: Melodie Domurad, PhD 7816817900 BEST@merit.com

Locations
United States, California
VA Greater Los Angeles Healthcare System Recruiting
Los Angeles, California, United States, 90073
Contact: Shirley Mena       shirley.mena@va.gov   
Principal Investigator: Carol Bennett, MD         
Sub-Investigator: Jeremy Shelton, MD         
Principal Investigator: Justin McWilliams, MD         
Sub-Investigator: Hsin Yi-Lee, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: L. Tracy Paz, RN    650-723-0948    lp2@stanford.edu   
Contact: Ida Bezabeh       ibezabeh@stanford.edu   
Sub-Investigator: Daniel Sze, MD         
Principal Investigator: Harsharan Gill, MD         
Sub-Investigator: John Louie, MD         
Sub-Investigator: David Hovsepian, MD         
Sub-Investigator: James Brooks, MD         
Sub-Investigator: Rajesh Shah, MD         
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Marco Ertreo       marco.ertreo@gunet.georgetown.edu   
Principal Investigator: James Spies, MD         
Sub-Investigator: Keith Kowalcyzk, MD         
Sub-Investigator: Alexander Kim, MD         
Sub-Investigator: John Lynch, MD         
Sub-Investigator: Meredith Preziosi, NP         
Sub-Investigator: Michelle Jones, NP         
United States, Florida
Holy Cross Hospital Withdrawn
Fort Lauderdale, Florida, United States, 33308
Miami VA Healthcare System Recruiting
Miami, Florida, United States, 33125
Contact: Michael Hyre       michael.hyre@va.gov   
Contact: Jennifer Denizard    305-575-7000 ext 3961    jennifer.denizard@va.gov   
Principal Investigator: Shivank Bhatia, MD         
Sub-Investigator: Bruce Kava, MD         
Sub-Investigator: Issam Kably, MD         
Sub-Investigator: Christopher Gomez, MD         
Sub-Investigator: Sanoj Punnen, MD         
Sub-Investigator: Seth Spector, MD         
University of Miami Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Clara Morales    302-243-3404    cmorales@med.miami.edu   
Principal Investigator: Shivank Bhatia, MD         
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Haydy Rojas, RN    813-892-0074    hrojas@tgh.org   
Contact: Ricci App       ricciapp@tgh.org   
Principal Investigator: Clifford Davis, MD         
Principal Investigator: Raviendar Bukkapatnam, MD         
United States, Maryland
Johns Hopkins Medical Center Recruiting
Baltimore, Maryland, United States, 21207
Contact: Elizabeth Fabian       efabian2@jhmi.edu   
Principal Investigator: Mark Lessne, MD         
Sub-Investigator: Stephen Schatz, MD         
Sub-Investigator: Kelvin Hong, MD         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Barbara MacDowell, RN    518-262-5356    bmacdowell@communitycare.com   
Contact: Brenda Romeo    518-262-8579    ccpurologyresearch@communitycare.com   
Principal Investigator: Gary Siskin, MD         
Sub-Investigator: Hugh Fisher, MD         
Sub-Investigator: Andrew McCullough, MD         
Sub-Investigator: Allen Herr, MD         
Sub-Investigator: Badar Mian, MD         
Sub-Investigator: Mark White, MD         
Sub-Investigator: Rebecca O'Malley, MD         
Sub-Investigator: Richard MacDowell, MD         
Sub-Investigator: Ronald Kaufman, MD         
Sub-Investigator: Carl E Diaz-Parker, RPA-C         
Sub-Investigator: Christopher Dotti, NP         
Sub-Investigator: Gail Egan, NP         
Sub-Investigator: Karla Giramonti, NP         
Sub-Investigator: Nancy Mitchell, NP         
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Madeline Rosado, NP       marosado@montefiore.org   
Contact: Keila Martin, PA       kemartin@montefiore.org   
Principal Investigator: Jacob Cynamon, MD         
Sub-Investigator: Lloyd Minsky, MD         
Sub-Investigator: Yosef Golowa, MD         
Sub-Investigator: Marcy Jagust, MD         
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Lourdes Campos-Grundvig, RN    212-824-7877    lourdes.campos-grundvig@mountsinai.org   
Sub-Investigator: Aaron Fischman, MD         
Principal Investigator: Neil Grafstein, MD         
Sub-Investigator: Rahul Patel, MD         
Sub-Investigator: Courtney Phillips, MD         
Sub-Investigator: Leslie Schlacter, PA         
Sub-Investigator: Simon Hall, MD         
Belgium
University Hospital Gasthuisberg - University Leuven Not yet recruiting
Leuven, Belgium
Contact: Elsa Goossens    32 16 34 83 45    elsa.goossens@uzleuven.be   
Principal Investigator: Geert Maleaux, MD         
Sub-Investigator: Ben VanCleyenbrudgel, MD         
France
Hôpital Européen Georges-Pompidou Withdrawn
Paris, France, 75908
Sponsors and Collaborators
Merit Medical Systems, Inc.
Investigators
Principal Investigator: Francisco Cesar Carnevale, PhD University of Sao Paolo, Brazil
  More Information

No publications provided

Responsible Party: Merit Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01789840     History of Changes
Other Study ID Numbers: BPH-P3-12-01, 2012-003446-33
Study First Received: February 8, 2013
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Merit Medical Systems, Inc.:
BPH
Prostate
Prostatic Hyperplasia
enlarged prostate
LUTS
urinary retention

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014