Overview
The researchers hope to learn if specific types of MRI software and techniques can help improve early prostate cancer detection at time of a MRI-guided prostate biopsy.
Description
A phase 2 prospective, interventional, non-randomized clinical trial design to investigate whether Restricted Spectrum Maps (RSM) attained from RSI-MRI (On-Q Prostate) improves PI-RADS accuracy compared to PI-RADS alone for the detection of clinically significant prostate cancer. Patients who have agreed to undergo an MRI and subsequent prostate needle biopsy will be approached to participate in the trial.
The aims of the study are as follows:
Goal 1. Validate RSI-MRI imaging biomarker performance using a prospective clinical trial.
Goal 2. Calibrate the RSM values across different MRI scanner manufacturers. Goal 3. Translate RSI using a net clinical benefit model.
Eligibility
Inclusion Criteria:
- Selected to undergo an MRI-fusion prostate needle biopsy of the prostate.
- Able to provide informed consent
Exclusion Criteria:
- prior diagnosis of prostate cancer (Grade Group >1)
- metastatic prostate cancer
- prior prostate cancer treatment
- contraindication to prostate biopsy (e.g., on anticoagulation that cannot be safely discontinued)
- inability to undergo MRI (e.g., too large to be accommodated in a scanner or with an implant incompatible with MRI).
- Bilateral hip replacement
- Unable to provide informed consent.