Gerald L. Andriole, Jr., MD, presented “The OPTIMUM Trial: 29 MHz Micro-Ultrasound vs. MRI in Diagnosis of Prostate Cancer” for the Grand Rounds in Urology audience in November 2021.

How to cite: Andriole, Gerald L. The OPTIMUM Trial: 29 MHz Micro-Ultrasound vs. MRI in Diagnosis of Prostate Cancer.” November 2021. Accessed Dec 2021. https://grandroundsinurology.com/the-optimum-trial-29-mhz-micro-ultrasound-vs-mri-in-diagnosis-of-prostate-cancer/

The OPTIMUM Trial: 29 MHz Micro-Ultrasound vs. MRI in Diagnosis of Prostate Cancer

 Gerald L. Andriole, Jr., MD, Robert K. Royce Distinguished Professor and Chief of Urologic Surgery at Barnes-Jewish Hospital, the Siteman Cancer Center, and Washington University School of Medicine in St. Louis, Missouri, introduces the OPTIMUM trial comparing high-resolution 29 MHz micro-ultrasound to MRI in the diagnosis of prostate cancer. After an introduction by E. David Crawford, MD, Professor of Urology at the University of California, San Diego, and Editor-in-Chief of Grand Rounds in Urology, Dr. Andriole explains that micro-ultrasound is a novel ultrasound-based system operating at 29 MHz that results in a 300 percent improvement in resolution compared to conventional ultrasound. He explains that micro-ultrasound can be used for transrectal or transperineal biopsy, with or without MRI. Dr. Andriole also notes that, like MRI with PI-RADS, micro-ultrasound has its own prostate risk identification using micro-ultrasound (PRI-MUS) classification system and works with all the skills urologists already have. He observes that several small studies have found superior or comparable sensitivity and/or clinically-significant prostate cancer detection with micro-ultrasound as compared to MRI, but that level 1 evidence is lacking. Dr. Andriole explains that the OPTIMUM trial, a 3-arm randomized controlled trial, is intended to fill in that gap and provide better evidence regarding micro-ultrasound’s efficacy. He describes the design of the trial, noting that 1200 biopsy-naïve subjects will be randomized to micro-ultrasound-only biopsy, MRI/micro-ultrasound “FusionVu” biopsy, and MRI/ultrasound biopsy with conventional fusion system, and that the trial is set to begin in winter 2021 and finish by spring 2023. The discussion concludes with a question and answer session in which Drs. Crawford and Andriole discuss which fusion platforms will be used, the price of micro-ultrasound, other potential applications for micro-ultrasound, and more.