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 Jan 2025. 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. 

ABOUT THE AUTHOR

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Gerald L. Andriole, Jr., MD, is Chief Medical Officer of Prostatype
Genomics. He retired in June 2023 from Johns Hopkins University
where he was Professor and Director of Urology in the National Capital
Region. Previously, he had been the Royce Distinguished Professor and
Chief of Urologic Surgery at Washington University in St. Louis for
over 20 years.

Dr. Andriole participated in the 5-year accelerated medical program at
Penn State University and Jefferson Medical College, Philadelphia, PA.
He trained in surgery at Strong Memorial Hospital, University of
Rochester, NY and completed urology residency at Brigham and
Women’s Hospital, Harvard Medical School, Boston, MA. He served a
fellowship in Urologic Oncology at the National Cancer Institute of NIH
in Bethesda, Maryland prior to joining the faculty at Washington
University.

Dr. Andriole has significant expertise in prostate cancer screening and
prevention. He was continuously funded by NIH from 1993 and has
contributed over 450 peer-reviewed publications (H-index of 110). He
chaired the Prostate Committee of NCI’s PLCO Cancer Screening Trial
and led the international REDUCE Prostate Cancer Chemoprevention
Trial. He also chaired the Prostate Committee of the Society of Urologic
Oncology Clinical Trials Consortium.
Dr. Andriole is an elected member of the American Surgical
Association, American Association of Genitourinary Surgeons, and the
Clinical Society of Genitourinary Surgeons. He received the
Outstanding Achievement Award from the Urologic Oncology Branch
of NCI, the Distinguished Clinician Award from Washington University,
the Distinguished Alumni Award from Jefferson Medical College and
the Williams Award for Prostate Cancer Research Excellence from the
American Urologic Association Urology Care Foundation.