Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

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.

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.

Inclusion Criteria:

• Men indicated for prostate biopsy due to elevated Prostate Specific Antigen and/or abnormal Digital Rectal Examination
• 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
• No history of mpMRI for clinical investigation of prostate cancer within 12 months prior to screening and enrollment in the study

Exclusion Criteria:

• History of prior prostate biopsy
• History of genitourinary cancer, including prostate cancer
• Contraindications to biopsy
• Contraindications to mpMRI