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OpenTrials
Completed

NCT Number: NCT03762616

Urology San Antonio MRI/MicroUS Comparison

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology San Antonio - Pasteur Plaza Surgery Center

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micro-ultrasound targeted biopsy

Diagnostic Test

Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system

mpMRI targeted biopsy

Diagnostic Test

Multiparametric MRI targeted biopsy using software assisted MRI/US fusion

Primary outcomes

  1. Number of Participants With Clinically Significant Cancer

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Exact Imaging

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2018
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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