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Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia

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ClinicalTrials.gov Identifier: NCT03055624
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Picel, MD, University of California, San Diego

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia, Benign Prostatic Hyperplasia With Urinary Obstruction With Lower Urinary Tract Symptoms Device: Embosphere microparticles for prostate artery embolization Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : February 18, 2019
Actual Study Completion Date : February 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prostate artery embolization
Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.
Device: Embosphere microparticles for prostate artery embolization
Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.




Primary Outcome Measures :
  1. Development of adverse events [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Change in prostate size [ Time Frame: 1, 6, 12, and 24 months ]
  2. Change in prostate specific antigen (PSA) lab value (ng/mL) [ Time Frame: 1, 6, 12, and 24 months ]
  3. Change in International prostate symptom score (IPSS) [ Time Frame: 1, 6, 12, and 24 months ]
  4. Change in post-void residual (PVR) on ultrasound [ Time Frame: 1, 6, 12, and 24 months ]
  5. Change in peak urinary flow rate (Qmax) [ Time Frame: 1, 6, 12, and 24 months ]
  6. Change in International index of erectile dysfunction (IIEF) [ Time Frame: 1, 6, 12, and 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055624


Locations
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United States, California
University of California San Diego
San Diego, California, United States, 92007
Sponsors and Collaborators
University of California, San Diego

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Responsible Party: Andrew Picel, MD, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03055624     History of Changes
Other Study ID Numbers: 161719
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Andrew Picel, MD, University of California, San Diego:
prostate artery embolization (PAE)
benign prostatic hyperplasia (BPH)
lower urinary tract symptoms (LUTS)
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms