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Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia

Primary Purpose

Prostatic Hyperplasia, Benign Prostatic Hyperplasia (BPH), Prostatism

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embozene Microspheres
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia focused on measuring Prostate Artery Embolization (PAE), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS), BPH, PAE, LUTS, Prostatic Artery Embolization

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients between ages 45-80 years
  • Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months
  • IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of <12mL/s (milliliters per second) .
  • All prostate volumes will be at least 40gm and no more than 400gm based on DRE, TRUS, or cross sectional imaging

Exclusion Criteria:

  • Patients with urinary tract infections (> 2/year), prostatitis, or interstitial cystitis
  • Cases of biopsy proven prostate cancer or urethral cancer.
  • Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study.
  • Patients who are classified as New York Heart Association Class III (Moderate), or higher.
  • Patients with history of prior pelvic irradiation.
  • Hypersensitivity reactions to contrast material not manageable with prophylaxis.
  • Patients with serum creatinine values >1.7mg/dl or glomerular filtration rates less than 50.

Sites / Locations

  • University of Virginia Health SystemsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Embozene Microspheres

Arm Description

Embozene Microspheres are spherical particles consisting of a hydrogel core and a poly nanocoat that will be used during study procedure, Prostatic Artery Embolization (PAE) to reduce or eliminate bloodflow to the prostate.

Outcomes

Primary Outcome Measures

Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
QMax (peak urinary flow rate) assessment
Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
QMax assessment
Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
IPSS (International Prostate Symptom Score)
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
IPSS
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
QoL(quality of life question)
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
QoL
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
QMax

Secondary Outcome Measures

Urine flow rate as measured by QMax
Urine flow rate as measured by QMax
Post-void residual measured in ml/cc
Post-void residual measured in ml/cc
UCLA-PCI-SF (University of California, Los Angeles Prostate Cancer Index Short Form) score
UCLA-PCI-SF score

Full Information

First Posted
October 26, 2015
Last Updated
April 15, 2019
Sponsor
University of Virginia
Collaborators
Siemens Medical Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT02592473
Brief Title
Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia
Official Title
Prostate Artery Embolization Safety and Efficacy: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Siemens Medical Solutions

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
The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Detailed Description
This pilot study is a prospective, non-randomized clinical trial assessing the safety and feasibility of prostatic artery embolization. Fifty adult male subjects will be enrolled and treated in this study. Patients who provide informed consent and are deemed eligible for participation will undergo prostatic artery embolization in the Interventional Radiology department at the University of Virginia. After performing an angiogram to identify the prostatic arteries, tiny particles known as Embozene Microspheres will be injected into the prostatic artery. Injecting these particles into the prostatic artery will slow blood flow to the prostate and thus shrinking the size of the prostate. By shrinking the size of the prostate, it is hopeful that it will provide relief of lower urinary tract symptoms due to BPH. Subjects will be followed for 2 years as part of their participation in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia, Benign Prostatic Hyperplasia (BPH), Prostatism, Lower Urinary Tract Symptoms (LUTS), Prostatic Hypertrophy, Hyperplasia, Male Urogenital Diseases, Genital Diseases, Male
Keywords
Prostate Artery Embolization (PAE), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS), BPH, PAE, LUTS, Prostatic Artery Embolization

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Embozene Microspheres
Arm Type
Experimental
Arm Description
Embozene Microspheres are spherical particles consisting of a hydrogel core and a poly nanocoat that will be used during study procedure, Prostatic Artery Embolization (PAE) to reduce or eliminate bloodflow to the prostate.
Intervention Type
Device
Intervention Name(s)
Embozene Microspheres
Intervention Description
Minimally invasive intra-arterial administration of particle embolics into prostate arteries under fluoroscopy and cone-beam CT imaging guidance.
Primary Outcome Measure Information:
Title
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
Description
QMax (peak urinary flow rate) assessment
Time Frame
12 months
Title
Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures
Time Frame
2 weeks
Title
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
Description
QMax assessment
Time Frame
24 months
Title
Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures
Time Frame
24 months
Title
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
Description
IPSS (International Prostate Symptom Score)
Time Frame
12 months
Title
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
Description
IPSS
Time Frame
24 months
Title
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
Description
QoL(quality of life question)
Time Frame
12 months
Title
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
Description
QoL
Time Frame
24 months
Title
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
Description
QMax
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Urine flow rate as measured by QMax
Time Frame
1 month
Title
Urine flow rate as measured by QMax
Time Frame
24 months
Title
Post-void residual measured in ml/cc
Time Frame
1 month
Title
Post-void residual measured in ml/cc
Time Frame
24 months
Title
UCLA-PCI-SF (University of California, Los Angeles Prostate Cancer Index Short Form) score
Time Frame
1 month
Title
UCLA-PCI-SF score
Time Frame
24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between ages 45-80 years Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of <12mL/s (milliliters per second) . All prostate volumes will be at least 40gm and no more than 400gm based on DRE, TRUS, or cross sectional imaging Exclusion Criteria: Patients with urinary tract infections (> 2/year), prostatitis, or interstitial cystitis Cases of biopsy proven prostate cancer or urethral cancer. Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study. Patients who are classified as New York Heart Association Class III (Moderate), or higher. Patients with history of prior pelvic irradiation. Hypersensitivity reactions to contrast material not manageable with prophylaxis. Patients with serum creatinine values >1.7mg/dl or glomerular filtration rates less than 50.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Feazell, BS
Phone
434-297-5682
Email
JF9RF@virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brigitte J Kelly, BSN RN CCRC
Phone
434-297-7136
Email
bjk3c@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziv J Haskal, MD
Organizational Affiliation
Professor of Radiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health Systems
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Feazell, BS
Phone
434-297-5682
Email
jf9rf@virginia.edu
First Name & Middle Initial & Last Name & Degree
Brigitte J Kelly, BSN RN CCRC
Phone
434-297-7136
Email
bjk3c@virginia.edu
First Name & Middle Initial & Last Name & Degree
Ziv J Haskal, MD

12. IPD Sharing Statement

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Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia

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