NCT02592473

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

6 years

First QC Date

October 26, 2015

Last Update Submit

April 15, 2019

Conditions

Prostatic HyperplasiaBenign Prostatic Hyperplasia (BPH)ProstatismLower Urinary Tract Symptoms (LUTS)Prostatic HypertrophyHyperplasiaMale Urogenital DiseasesGenital Diseases, Male

Keywords

Prostate Artery Embolization (PAE)Benign Prostatic Hyperplasia (BPH)Lower Urinary Tract Symptoms (LUTS)BPHPAELUTSProstatic Artery Embolization

Outcome Measures

Primary Outcomes (9)

  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS)

    QMax (peak urinary flow rate) assessment

    12 months

  • Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures

    2 weeks

  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS)

    QMax assessment

    24 months

  • Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures

    24 months

  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS)

    IPSS (International Prostate Symptom Score)

    12 months

  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS)

    IPSS

    24 months

  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS)

    QoL(quality of life question)

    12 months

  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS)

    QoL

    24 months

  • Clinical improvement in Lower Urinary Tract Symptoms (LUTS)

    QMax

    24 months

Secondary Outcomes (6)

  • Urine flow rate as measured by QMax

    1 month

  • Urine flow rate as measured by QMax

    24 months

  • Post-void residual measured in ml/cc

    1 month

  • Post-void residual measured in ml/cc

    24 months

  • UCLA-PCI-SF (University of California, Los Angeles Prostate Cancer Index Short Form) score

    1 month

  • +1 more secondary outcomes

Study Arms (1)

Embozene Microspheres

EXPERIMENTAL

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.

Device: Embozene Microspheres

Interventions

Embozene MicrospheresDEVICE

Minimally invasive intra-arterial administration of particle embolics into prostate arteries under fluoroscopy and cone-beam CT imaging guidance.

Embozene Microspheres

Eligibility Criteria

Age45 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Health Systems

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Prostatic HyperplasiaProstatismLower Urinary Tract SymptomsHyperplasiaMale Urogenital DiseasesGenital Diseases, Male

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital DiseasesUrogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Ziv J Haskal, MD

    Professor of Radiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Feazell, BS

CONTACT

434-297-5682JF9RF@virginia.edu

Brigitte J Kelly, BSN RN CCRC

CONTACT

434-297-7136bjk3c@virginia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2015

First Posted

October 30, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

US(1)