Micro-UltraSound In Cancer - Active Surveillance
Recruiting · NCT05558241 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alberta
View the official record on ClinicalTrials.gov →Interventions studied
High-resolution micro-ultrasound
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
6 locations listed across 1 US state.
- University of California Los Angeles, Department of Urology - Los Angeles, California, United States
- Humanitas - Milan, Italy
- University Hospital Centre Zagreb - Zagreb, Croatia
- Kipnes Urology Centre - Kaye Edmonton Clinic - Edmonton, Alberta, Canada
- University of British Columbia - Vancouver, Alberta, Canada
- CIUSSS du Nord-de-L'Ile-De-Montreal - Montreal, Quebec, Canada