CLINICAL TRIAL OF PROSTATE MRI AND PI-RADS VERSION 2

Introduction

AdMeTech led design, management and implementation of a clinical trial to study the role of prostate multi-parametric (mp) MRI and its global, standardized Prostate Imaging – Reporting and Data System version 2 (PI-RADS v2). The assembled research team included Harvard Medical School’s Brigham and Women’s, Massachusetts General, and Boston Children’s Hospitals, as well as American College of Radiology Imaging Network’s Statistical Center at Brown University.

This clinical trial was phase II retrospective, statistically powered study that recruited 389 patients who were diagnosed with prostate cancer and underwent surgery at the Brigham and Women’s Hospital between 2008 and 2014.

This study showed that mpMRI and PI-RADS v2 can play a groundbreaking role in prostate cancer care by improving sensitivity for and prediction of clinically significant prostate cancer. We have shown that mpMRI and PI-RADS v2 can improve diagnosis of aggressive prostate cancer nearly 5 times and proportionately reduce surgery for indolent disease. While very promising, these results indicate the need for further prospective, large-scale, multi-center studies.

Research Goals and Results

The goals and results of this research are the following:

1. To study accuracy of mpMRI and PI-RADS v2 in detecting clinically significant prostate cancer, including Sensitivity, Specificity, Negative Predictive Value (NPV), and Positive Predictive Value (PPV).
   • This research showed high sensitivity and PPV of PI-RADS v2. Read more
2. To study the role of mpMRI and PI-RADS v2 in reducing surgery for low-risk, indolent prostate cancer, which is unlikely to cause symptoms in a man’s lifetime.
   • This research showed that when PI-RADS v2 is suspicious for aggressive prostate cancer, mpMRI can reduce surgery for indolent prostate cancer significantly, in 89 to 97% of men. Read more
3. To study the impact of mpMRI and PI-RADS v2 on detecting aggressive prostate cancer.
   • This research showed that when PI-RADS v2 is suspicious, mpMRI can improve diagnosis of aggressive, clinically significant prostate cancer nearly 5 times compared to standard diagnostic tools, including transrectal ultrasound (TRUS) biopsies. Read more

Principal Investigators

Faina Shtern, MD

CEO & President of AdMeTech Foundation

Clare M. Tempany-Afdhal, MD, MB BAO, BCh

Ferenc Jolesz MD Professor of Radiology at Harvard Medical School, Vice Chair of Research at the Department of Radiology, Brigham and Women’s Hospital 

Research Team

Fiona Fennessy, MD, BCh, PhD

Associate Professor of Radiology, Harvard Medical School, Faculty radiologist, Brigham & Women’s Hospital, Program Director, Cancer Imaging Fellowship Program, Institute Physician, Dana-Farber Cancer Institute

Mukesh Harisinghani, MD

Professor of Radiology, Harvard Medical School and Director of Abdominal MRI, Massachusetts General Hospital

Elmira Hassenzadeh, MD

Research Fellow in Radiology, Brigham and Women’s Hospital, Harvard Medical School

Michelle S. Hirsch, MD, PhD

Associate Pathologist, Surgical Pathology, Brigham and Women’s Hospital, Harvard Medical School

Adam S. Kibel, MD

Elliott Carr Cutler Professor of Surgery, Harvard Medical School, and Chief of Urology, Brigham and Women’s Hospital and Dana Farber Cancer Institute; and Member, National Comprehensive Cancer Network (NCCN)’s Prostate Cancer Early Detection Panel

Quoc-Dien Trinh, MD

Assistant Professor of Urology, Harvard Medical School 

Zheng Zhang, PhD 

Adjunct Assistant Professor of Biostatistics, Brown University

David Zurakowski, PhD

Associate Professor, Harvard Medical School and Director of Biostatistics, Department of Anesthesiology, Critical Care and Pain Medicine