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Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia

Primary Purpose

Prostatic Hyperplasia, Benign, Enlarged Prostate With Lower Urinary Tract Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embosphere microparticles for prostate artery embolization
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia, Benign focused on measuring prostate artery embolization (PAE), benign prostatic hyperplasia (BPH), lower urinary tract symptoms (LUTS)

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostate artery embolization

Arm Description

Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
The study protocol was terminated before completion as the device was FDA approved and determined to be safe for the treated patient population.

Secondary Outcome Measures

Change in International Prostate Symptom Score (IPSS)
International Prostate Symptom Score change from baseline measured at 1 and 6 months. The IPSS scale grades lower urinary tract symptoms on a scale ranging from 0 (no symptoms) to 35 (severe). Patients answer 7 questions about symptoms they have had in the past month and grade each symptom severity for each question on a scale from 0 (not at all) to 5 (almost always). Change is reported as outcome measure time point minus baseline. A positive value indicates improved symptoms and negative value worsened symptoms.
Change in Post-void Residual (PVR) on Ultrasound
PVR (mL) change from baseline measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates less post-void residual and a positive value indicates greater PVR at each outcome time point.
Change in Peak Urinary Flow Rate (Qmax)
Change in Qmax measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A positive value indicates improved Qmax and negative value indicates decreased Qmax at each outcome time point.
Change in International Index of Erectile Dysfunction (IIEF)
IIEF score change from baseline measured at 1 and 6 months. International Index of Erectile Function (IIEF) is a scale grading erectile function based on 5 questions. Questions are answered from 1 (low function) to 5 (high function). Total scores range from 5 to 25. A total score of 5-7 is severe erectile dysfunction, 8 to 11 is moderate erectile dysfunction, 12 to 16 is mild to moderate erectile dysfunction, 17 to 21 is mild erectile dysfunction, and 22-25 is no erectile dysfunction. Change is reported as outcome measure time point minus baseline. A positive value indicates improved erectile function and a negative indicates worsened erectile function.
Change in Prostate Volume (PV)
Change in prostate volume measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates decreased prostate volume and a positive value indicates increased prostate volume.

Full Information

First Posted
February 9, 2017
Last Updated
March 18, 2020
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT03055624
Brief Title
Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia
Official Title
Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
February 18, 2019 (Actual)
Study Completion Date
February 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia, Benign, Enlarged Prostate With Lower Urinary Tract Symptoms
Keywords
prostate artery embolization (PAE), benign prostatic hyperplasia (BPH), lower urinary tract symptoms (LUTS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prostate artery embolization
Arm Type
Experimental
Arm Description
Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.
Intervention Type
Device
Intervention Name(s)
Embosphere microparticles for prostate artery embolization
Intervention Description
Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
The study protocol was terminated before completion as the device was FDA approved and determined to be safe for the treated patient population.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in International Prostate Symptom Score (IPSS)
Description
International Prostate Symptom Score change from baseline measured at 1 and 6 months. The IPSS scale grades lower urinary tract symptoms on a scale ranging from 0 (no symptoms) to 35 (severe). Patients answer 7 questions about symptoms they have had in the past month and grade each symptom severity for each question on a scale from 0 (not at all) to 5 (almost always). Change is reported as outcome measure time point minus baseline. A positive value indicates improved symptoms and negative value worsened symptoms.
Time Frame
baseline, 1 month, 6 month
Title
Change in Post-void Residual (PVR) on Ultrasound
Description
PVR (mL) change from baseline measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates less post-void residual and a positive value indicates greater PVR at each outcome time point.
Time Frame
baseline, 1 month, 6 month
Title
Change in Peak Urinary Flow Rate (Qmax)
Description
Change in Qmax measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A positive value indicates improved Qmax and negative value indicates decreased Qmax at each outcome time point.
Time Frame
Baseline, 1 month, 6 month
Title
Change in International Index of Erectile Dysfunction (IIEF)
Description
IIEF score change from baseline measured at 1 and 6 months. International Index of Erectile Function (IIEF) is a scale grading erectile function based on 5 questions. Questions are answered from 1 (low function) to 5 (high function). Total scores range from 5 to 25. A total score of 5-7 is severe erectile dysfunction, 8 to 11 is moderate erectile dysfunction, 12 to 16 is mild to moderate erectile dysfunction, 17 to 21 is mild erectile dysfunction, and 22-25 is no erectile dysfunction. Change is reported as outcome measure time point minus baseline. A positive value indicates improved erectile function and a negative indicates worsened erectile function.
Time Frame
baseline, 1 month, 6 month
Title
Change in Prostate Volume (PV)
Description
Change in prostate volume measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates decreased prostate volume and a positive value indicates increased prostate volume.
Time Frame
baseline, 1 month, 6 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Prostate volume between 40 and 300 cm3 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 Refractory or intolerant to medical management Ineligibility for or refusal of surgical management 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: History of prostate, bladder or rectal malignancy. Biopsy proven urethral cancer. History of rectal disease Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal cord injury, diabetes, etc., as demonstrated on urodynamic testing. Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other than BPH, as demonstrated on urodynamic testing Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm Cystolithiasis within the past three months Baseline serum creatinine greater than 1.8 Evidence of tortuous or atherosclerotic blood vessels Presence of collateral vessel pathways potentially endangering normal territories during embolization that cannot be bypassed with the microcatheter Active urinary tract infection, interstitial cystitis, or prostatitis within the last 5 years Coagulation disturbances not normalized by medical treatment Allergy to iodinated contrast agents not responsive to steroid premedication regimen Previous radical pelvic or rectal surgery, or pelvic irradiation Prior surgical prostate intervention 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 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 Interest in future fertility Mental condition or disorder that interferes with participants' ability to provide written informed consent 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 Known immunosuppression Life expectancy less than 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Picel, MD
Organizational Affiliation
UCSD Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia

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