Urology of Virginia Case Series
Primary Purpose
Prostate Cancer, Cancer of the PROSTATE, Prostatic Neoplasm
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound guided prostate exam using SOC ultrasound system
mpMRI guided prostate examination using PI-RADS v2
High-resolution micro-ultrasound guided prostate biopsy
Sponsored by
About this trial
This is an interventional device feasibility trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- All men ≥ 40 years age and <80 years of age with a history of prostate cancer and an indication for a prostate biopsy will be offered inclusion in the study. Typical indications for biopsy include abnormal PSA (prostate specific antigen) and/or abnormal DRE (digital rectal exam) and/or history of prostate cancer.
- PSA<50
- Clinical stage < cT2c
Exclusion Criteria:
Patients will be excluded from being included in the investigation if any of the following is true:
- Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia
- Men with known prostate volume (from prior imaging) of > 60cc
- Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
- Men who are unable to provide their own informed consent
- Men who have contraindications to MRI or gadolinium chelate contrast
Sites / Locations
- Urology of Virginia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Micro-ultrasound
Arm Description
Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities: Low resolution transrectal ultrasound examination ("LR-TRUS") Multi-parametric MRI ("mpMRI") examination performed according to the PI-RADS v2 protocol
Outcomes
Primary Outcome Measures
Keyword Description of Each Biopsy Sample
The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03035487
Brief Title
Urology of Virginia Case Series
Official Title
Urology of Virginia Case Series
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Exact Imaging
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigational protocol describes a small case series designed to compare three imaging modalities for use in visualizing prostate cancer.
The three modalities to be tested are: transrectal micro-ultrasound , and conventional resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI (mpMRI).
These modalities will be used for guiding systematic (standard, random, extended sextant) plus image-guided targeted prostate biopsies among men with known cancer and an indication for prostate biopsy.
In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the radiology report used for targeting.
Detailed Description
This trial will enroll nine men with an indication for a prostate biopsy.
The primary objective of the study is to provide guidance to clinicians who will be using the ExactVu system on the appearance of suspicious foci, and the difference between the appearance of these foci in LR-TRUS, mpMRI and transrectal micro-ultrasound images.
The study is being conducted based on the hypothesis that a series of same-subject comparisons will clearly demonstrate the differences in appearance between the modalities.
Procedures in the study are:
obtain informed consent for the subject
image the subject using mpMRI according to the PI-RADS v2 protocol, and obtain radiologist's report
perform biopsy procedure using micro-ultrasound (this may be conducted in a separate subject visit)
prepare biopsy specimens for pathology
record all procedure details in a case report form, including pathology and mpMRI reports
The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities.
Secondary endpoints are the pathological result of each biopsy sample (Gleason Score and percentage of cancer in sample), and risk score identified on imaging. Both of these values are per-sample, with 12 systematic samples per subject plus any additional targeted samples warranted by standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Cancer of the PROSTATE, Prostatic Neoplasm
7. Study Design
Primary Purpose
Device Feasibility
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
Micro-ultrasound
Arm Type
Experimental
Arm Description
Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:
Low resolution transrectal ultrasound examination ("LR-TRUS")
Multi-parametric MRI ("mpMRI") examination performed according to the PI-RADS v2 protocol
Intervention Type
Device
Intervention Name(s)
Ultrasound guided prostate exam using SOC ultrasound system
Intervention Type
Device
Intervention Name(s)
mpMRI guided prostate examination using PI-RADS v2
Intervention Description
mpMRI guided prostate examination using standard of care MRI system
Intervention Type
Device
Intervention Name(s)
High-resolution micro-ultrasound guided prostate biopsy
Other Intervention Name(s)
ExactVu micro-ultrasound imaging system
Primary Outcome Measure Information:
Title
Keyword Description of Each Biopsy Sample
Description
The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound.
Time Frame
For each patient, keywords will be assigned within one week following the patient's procedure.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All men ≥ 40 years age and <80 years of age with a history of prostate cancer and an indication for a prostate biopsy will be offered inclusion in the study. Typical indications for biopsy include abnormal PSA (prostate specific antigen) and/or abnormal DRE (digital rectal exam) and/or history of prostate cancer.
PSA<50
Clinical stage < cT2c
Exclusion Criteria:
Patients will be excluded from being included in the investigation if any of the following is true:
Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia
Men with known prostate volume (from prior imaging) of > 60cc
Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
Men who are unable to provide their own informed consent
Men who have contraindications to MRI or gadolinium chelate contrast
Facility Information:
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Urology of Virginia Case Series
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