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Prostatic Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)

Primary Purpose

Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prostatic artery embolization
Sponsored by
Andrew Picel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 45 years and ≤ 85 years old
  • Prostate volume ≥ 40 mL and ≤ 300 mL
  • Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS)
  • Refractory or intolerant to medical management
  • Ineligibility for or refusal of surgical management
  • No evidence of prostate cancer

Exclusion Criteria:

  • History of pelvic cancer
  • Neurogenic bladder disorder
  • Bladder diverticula greater than 5 cm or bladder stones
  • Acute urinary retention with Foley catheter dependence
  • Active urinary tract infection, interstitial cystitis, or prostatitis within the last 3 months
  • Prior surgical prostate intervention
  • Active participation in another clinical trial

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Balloon occlusion microcatheter

Standard microcatheter

Arm Description

Participants will undergo the PAE procedure using LC Bead LUMI delivered through a balloon occlusion microcatheter.

Participants will undergo the PAE procedure using LC Bead LUMI delivered through a standard microcatheter.

Outcomes

Primary Outcome Measures

Number of patients with treatment related adverse events assessed by CTCAE v4.0.
Mean change from baseline in symptom score using the IPSS scale at 6 months

Secondary Outcome Measures

Mean change from baseline in Qmax (maximum urinary flow)
Mean change from baseline in PVR (post void residual)
Mean change from baseline in prostate volume
Mean change from baseline in IPSS to measure long-terms subjective outcome

Full Information

First Posted
September 20, 2020
Last Updated
September 26, 2021
Sponsor
Andrew Picel
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1. Study Identification

Unique Protocol Identification Number
NCT04563221
Brief Title
Prostatic Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
Official Title
Prostatic Artery Embolization (PAE) Using LC Bead LUMI for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Funding not approved
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrew Picel

4. Oversight

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
Yes

5. Study Description

Brief Summary
This is a single center, prospective, investigational study to evaluate the safety and efficacy of prostatic artery embolization (PAE) for the treatment of moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Embolization will be performed with LC Bead LUMI particles using a balloon occlusion microcatheter or standard microcatheter.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balloon occlusion microcatheter
Arm Type
Experimental
Arm Description
Participants will undergo the PAE procedure using LC Bead LUMI delivered through a balloon occlusion microcatheter.
Arm Title
Standard microcatheter
Arm Type
Experimental
Arm Description
Participants will undergo the PAE procedure using LC Bead LUMI delivered through a standard microcatheter.
Intervention Type
Device
Intervention Name(s)
Prostatic artery embolization
Intervention Description
Prostatic artery embolization is performed using LC Bead LUMI, which is the investigational device. The particles are administered to the prostatic arteries using either a balloon occlusion or standard microcatheter. Follow-up is performed at 1 month, 6 months, 12 months, and 24 months after intervention.
Primary Outcome Measure Information:
Title
Number of patients with treatment related adverse events assessed by CTCAE v4.0.
Time Frame
12 months post PAE
Title
Mean change from baseline in symptom score using the IPSS scale at 6 months
Time Frame
Baseline and 6 months post PAE
Secondary Outcome Measure Information:
Title
Mean change from baseline in Qmax (maximum urinary flow)
Time Frame
Baseline, 6 months and 12 months post PAE
Title
Mean change from baseline in PVR (post void residual)
Time Frame
Baseline, 6 months and 12 months post PAE
Title
Mean change from baseline in prostate volume
Time Frame
Baseline, 6 months and 12 months post PAE
Title
Mean change from baseline in IPSS to measure long-terms subjective outcome
Time Frame
Baseline, 12 and 24 months post PAE

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 45 years and ≤ 85 years old Prostate volume ≥ 40 mL and ≤ 300 mL Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS) Refractory or intolerant to medical management Ineligibility for or refusal of surgical management No evidence of prostate cancer Exclusion Criteria: History of pelvic cancer Neurogenic bladder disorder Bladder diverticula greater than 5 cm or bladder stones Acute urinary retention with Foley catheter dependence Active urinary tract infection, interstitial cystitis, or prostatitis within the last 3 months Prior surgical prostate intervention Active participation in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Picel, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prostatic Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)

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