OPTIMUM is a study designed to compare the ability of ultra-high resolution transrectal
micro-ultrasound (microUS) and multiparametric MRI (mpMRI)/US fusion to guide prostate
biopsy.
Additional locations may be listed on ClinicalTrials.gov for NCT05220501.
See trial information on ClinicalTrials.gov for a list of participating sites.
The purpose of the Clinical Investigation Plan and Study Protocol is to present
information for the OPTIMUM clinical investigation, including the scientific basis for
the study, the procedural details, the ExactVu High Resolution Micro-Ultrasound System,
its safety details, and administrative details. It has been designed in such a way as to
optimize the scientific validity and reproducibility of the results of the study in
accordance with current clinical knowledge and practice so as to fulfill the objectives
of the investigation.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationOdette Cancer Centre- Sunnybrook Health Sciences Centre
