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.
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.
Men indicated for prostate biopsy due to elevated PSA and/or abnormal DRE No history of prior prostate biopsy No history of genitourinary cancer, including prostate cancer 18 years or older No contraindications to biopsy No contraindications to mpMRI
Exclusion Criteria:
History of prior prostate biopsy History of genitourinary cancer, including prostate cancer Contraindications to biopsy Contraindications to mpMRI
