Prostate Cancer
Conditions
Keywords
Active surveillance, micro-ultrasound
Brief summary
This study will compare the two imaging modalities (MRI and micro-ultrasound) during Active Surveillance of prostate cancer (PCa). Progression to clinically significant PCa will be assessed by first taking micro-US targeted samples (while blinded to MRI results), followed by MRI targeted samples, finishing with 12 systematic biopsy cores. The primary goal is to compare microUS to MRI for the detection of ≥GG2 PCa at confirmatory biopsy. This study will also collect blood samples from participants to be used for future biomarker studies.
Interventions
DEVICEHigh-resolution micro-ultrasound
In a single biopsy session, first, a microUS-guided biopsy of regions of interest (ROIs) will be performed. The MRI fusion software will then be turned on, the clinician unblinded to the MRI results, and biopsy cores from within the boundaries of the MRI-fused lesion will be sampled from ROIs. Up to two ROIs identified on microUS or MRI will be targeted with up to 3 cores per ROI. If the MRI ROIs overlap with the microUS ROIs after unblinding, then the cores taken during the microUS-guided biopsy will be counted as both microUS and MRI-guided. Finally, a standard 12-core systematic biopsy will be performed.
Sponsors
University of Alberta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective paired diagnostic trial
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult men with Gleason Grade Group 1 prostate cancer managed by active surveillance who require a confirmatory prostate biopsy
Exclusion criteria
* Men who cannot undergo a prostate MRI * Men who cannot undergo a prostate biopsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cancer upgrading during Active surveillance by micro-ultrasound and MRI | Immediately after biopsy. | The primary outcome will be detection of ≥Grade Group 2 by each biopsy, technique in combination with the systematic biopsy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cancer upgrading during Active surveillance between imagine-guided versus systematic biopsy. | Immediately after biopsy. | Secondary outcome will compare each imaged-guided biopsy technique to the standard-of-care 12 core systematic biopsy simultaneously obtained. |
Countries
Canada, Croatia, Italy, United States
Contacts
PRINCIPAL_INVESTIGATORAdam Kinnaird, MD, PhD
University of Alberta
Outcome results
None listed