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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03762616
Other study ID # EVU-2018-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 28, 2018
Est. completion date November 4, 2019

Study information

Verified date March 2021
Source Exact Imaging
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date November 4, 2019
Est. primary completion date November 4, 2019
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria: 1. Men presenting for prostate biopsy due to clinical suspicion of prostate cancer 2. 40-75 years old 3. Available mpMRI images and report, performed according to the PI-RADS v2 standard Exclusion Criteria: 1. Men with anorectal abnormalities preventing TRUS-guided prostate biopsy 2. Men who are unable to provide their own informed consent 3. Prostate volume on MRI > 100cc

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Micro-ultrasound targeted biopsy
Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system
mpMRI targeted biopsy
Multiparametric MRI targeted biopsy using software assisted MRI/US fusion

Locations

Country Name City State
United States Urology San Antonio - Pasteur Plaza Surgery Center San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Exact Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At time of biopsy
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