Prostate Cancer
Conditions
Keywords
multiparametric MRI, micro-ultrasound, prostate biopsy
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.
Interventions
DIAGNOSTIC_TESTMicro-ultrasound targeted biopsy
Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system
DIAGNOSTIC_TESTmpMRI targeted biopsy
Multiparametric MRI targeted biopsy using software assisted MRI/US fusion
Sponsors
Exact Imaging
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Masking description
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.
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Micro-ultrasound Biopsy Then MRI Biopsy Micro-ultrasound targeted biopsy: Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system Followed in the same session by... mpMRI targeted biopsy: Multiparametric MRI targeted biopsy using software assisted MRI/US fusion | 118 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | Micro-ultrasound Biopsy Then MRI Biopsy | — |
|---|---|---|
| Age, Continuous | 67 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 118 Participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 118 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 118 | 0 / 118 |
| other Total, other adverse events | 0 / 118 | 0 / 118 |
| serious Total, serious adverse events | 0 / 118 | 0 / 118 |
Outcome results
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.
Time frame: At time of biopsy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Micro-ultrasound Biopsy | Number of Participants With Clinically Significant Cancer | 38 Participants |
| MRI Targeted Biopsy | Number of Participants With Clinically Significant Cancer | 31 Participants |