Urology San Antonio MRI/MicroUS Comparison

Not Applicable

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT03762616
• Lead Sponsor: Exact Imaging

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.

Study Timeline

• Study First Submitted: 2018-11-27
• Study Start: 2018-11-28
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-04
• Primary Completion: 2019-11-04
• Study Completion: 2019-11-04
• Status Verified: 2021-03
• Results First Submitted: 2021-03-02
• Results First Submitted QC: 2021-03-25
• Last Update Submitted: 2021-03-25
• Results First Posted: 2021-04-21
• Last Update Posted: 2021-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinically Significant Cancer	At time of biopsy	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.

Trial Locations

Locations (1)

Urology San Antonio - Pasteur Plaza Surgery Center; 🇺🇸 San Antonio, Texas, United States