Project Summary/Abstract
Prostate cancer affects nearly 1 in 7 men in the United States yet the diagnosis of early aggressive cancer
remains elusive at the expense of many unnecessary biopsies, delay in diagnosis from biopsy sampling error,
or the diagnosis of indolent disease. In order make a diagnose clinically significant prostate cancer, there is an
urgent need find an imaging modality that can be implemented uniformly, yet also provide clinical utility. MRI-
guided prostate biopsy has rapidly become a common modality to perform prostate biopsy; however, limited
emphasis has been placed on the quality and accuracy of the image acquisition.
Our proposal supports an academic-industry partnership to develop and imaging biomarker that could
revolutionize how prostate cancer is diagnosed and monitored by using restriction spectrum imaging (RSI)-MRI.
We seek to improve the operating characteristics of prostate MRI with a novel, non-invasive method of a short-
duration, targeted magnetic RSI-MRI sequences then undergo FDA-cleared, class II post-processing software
(OnQ Prostate) to attribute values to suspicious areas of the prostate. RSI-MRI employs multiple b-value
acquisitions with multiple diffusion gradient directions at each b-value to acquire raw data; images are post-
processed to isolate the signal from isotropic, restricted water compartments typically found in cancer cells. A
resultant “restricted signal map” corresponding to tumor location is derived and quantified functioning as an in
vivo biomarker of tumor grade and enhances tumor conspicuity for reader detection. In Aim 1, weseek to validate
our previous findings regarding the operating characteristics of the RSM values and its association with clinically
significant prostate cancer (grade group 2 or higher). We will use a non-randomized, single arm clinical trial to
investigate both PI-RADS scores with and without the RSM values. In Aim 2, we see to calibrate the RSM map
values across manufacturers(Siemens, GE, and Phillips MRI scanners). We will use a two-scan approach which
will invite a sample of men with a range of PI-RADS values to undergo a research reference scan after they have
undergone their standard of care scan within one of three locations housing a specific MRI vendor. The two
scans will be compared and used to calibrate the RSM values using several calibration and normalization
techniques with targeted biopsy results. In some men that do undergo prostatectomy, we will further make a
mold of the prostate using the preoperative MRI then perform whole-mount sectioning, scanning, and alignment
with RSI-MRI to obtain accurate reads of normal and cancer areas. In Aim 3, we will compare RSM to currently
available FDA-approved biomarkers and clinical risk to determine clinical utility.
In the proposed project, we seek to improve specificity of prostate MRI using RSI. Specific deliverables will
include the ability to amend the standard radiological reporting system (PI-RADS) withspecific RSM output vales.
We seek to validate the restricted signal maps between vendors and provide clinical assessment tools
demonstrating a measurement of clinical utility.
