Back to resultsUrology San Antonio MRI/MicroUS Comparison
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Micro-ultrasound targeted biopsy
mpMRI targeted biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring multiparametric MRI, micro-ultrasound, prostate biopsy
Eligibility Criteria
Inclusion Criteria:
- Men presenting for prostate biopsy due to clinical suspicion of prostate cancer
- 40-75 years old
- Available mpMRI images and report, performed according to the PI-RADS v2 standard
Exclusion Criteria:
- Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
- Men who are unable to provide their own informed consent
- Prostate volume on MRI > 100cc
Sites / Locations
- Urology San Antonio - Pasteur Plaza Surgery Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Micro-Ultrasound Biopsy
MRI Targeted Biopsy
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Clinically Significant Cancer
Comparison of subject-level detection rate of clinically significant cancer (csPCa, defined as Grade Group 2 or higher) between micro-ultrasound targeted biopsy and mpMRI targeted biopsy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03762616
Brief Title
Urology San Antonio MRI/MicroUS Comparison
Official Title
Urology San Antonio MRI/MicroUS Comparison
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 28, 2018 (Actual)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
November 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Exact Imaging
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study compares micro-ultrasound image targeted prostate biopsy with multi-parametric MRI targeted biopsy in men indicated for prostate biopsy due to suspicion of prostate cancer. Both imaging techniques will be applied to each subject and compared, along with systematic biopsy.
Detailed Description
The investigational protocol describes a study designed to compare ultra-high resolution transrectal micro-ultrasound (micro-US), and multi-parametric MRI (mpMRI). These modalities are both used clinically to identify targets for prostate biopsy, however little data is available to compare their sensitivity. While mpMRI is used clinically to identify targets for biopsy, it is not used for real-time biopsy guidance due to challenges performing the biopsy procedure within the MRI gantry. Instead, targets identified on mpMRI are sampled during transrectal ultrasound guided biopsy as part of the prostate biopsy procedure, often using software assisted fusion products. For this investigation, the biopsy procedure will be guided by transrectal micro-US (current standard of care at Urology San Antonio), and will include systematic (standard, random, extended sextant) plus image-guided prostate biopsies among men with clinical suspicion of prostate cancer and an indication for prostate biopsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
multiparametric MRI, micro-ultrasound, prostate biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Masking Description
Investigator performing the micro-ultrasound biopsy will be blinded to the MRI report, and the investigator performing the MRI targeted biopsy will be blinded to the micro-ultrasound images and targets.
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Micro-Ultrasound Biopsy
Arm Type
Experimental
Arm Title
MRI Targeted Biopsy
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Micro-ultrasound targeted biopsy
Intervention Description
Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system
Intervention Type
Diagnostic Test
Intervention Name(s)
mpMRI targeted biopsy
Intervention Description
Multiparametric MRI targeted biopsy using software assisted MRI/US fusion
Primary Outcome Measure Information:
Title
Number of Participants With Clinically Significant Cancer
Description
Comparison of subject-level detection rate of clinically significant cancer (csPCa, defined as Grade Group 2 or higher) between micro-ultrasound targeted biopsy and mpMRI targeted biopsy.
Time Frame
At time of biopsy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men presenting for prostate biopsy due to clinical suspicion of prostate cancer
40-75 years old
Available mpMRI images and report, performed according to the PI-RADS v2 standard
Exclusion Criteria:
Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
Men who are unable to provide their own informed consent
Prostate volume on MRI > 100cc
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Talley, MD
Organizational Affiliation
Urology San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology San Antonio - Pasteur Plaza Surgery Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Urology San Antonio MRI/MicroUS Comparison
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