Urology San Antonio MRI/MicroUS Comparison

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-28

Study Completion Date

2019-11-04

Brief Summary

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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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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

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.

Study Groups

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Micro-Ultrasound Biopsy

Group Type EXPERIMENTAL

Micro-ultrasound targeted biopsy

Intervention Type DIAGNOSTIC_TEST

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

MRI Targeted Biopsy

Group Type EXPERIMENTAL

mpMRI targeted biopsy

Intervention Type DIAGNOSTIC_TEST

Multiparametric MRI targeted biopsy using software assisted MRI/US fusion

Interventions

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Micro-ultrasound targeted biopsy

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

Intervention Type DIAGNOSTIC_TEST

mpMRI targeted biopsy

Multiparametric MRI targeted biopsy using software assisted MRI/US fusion

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No