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Phase Device Post-Market

Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI: A 3-arm Randomized Controlled Trial Evaluating the Role of 29MHz Micro-ultrasound in Guiding Prostate Biopsy in Men With Clinical Suspicion of Prostate Cancer.

  • Study HIC#:2000033223
  • Last Updated:10/31/2023

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.

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    For more information about this study, including how to volunteer, contact:

    Mari-Lynet Knight

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    Trial Purpose and Description

    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.

    Eligibility Criteria

    Inclusion Criteria:

    • 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

    Principal Investigator


    For more information about this study, including how to volunteer, contact: