Urology San Antonio MRI/MicroUS Comparison

Exact imaging

Status: Completed

Conditions: Prostate Cancer

Treatments: Diagnostic Test: Micro-ultrasound targeted biopsy; Diagnostic Test: mpMRI targeted biopsy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03762616

EVU-2018-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Male

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Micro-Ultrasound Biopsy

Experimental group

Treatment:

Diagnostic Test: Micro-ultrasound targeted biopsy

MRI Targeted Biopsy

Experimental group

Treatment:

Diagnostic Test: mpMRI targeted biopsy