Advanced Restriction Imaging and Reconstruction Technology for Prostate MRI (ART-Pro)
University of California, San Diego
Summary
This is a multicenter, multinational trial to evaluate advanced MRI techniques for improved detection of clinically significant prostate cancer (csPCa). The study will enroll 500 participants at 5 clinical centers (100 participants per center). The current standard MRI technique for prostate cancer screening is multiparametric MRI (mpMRI), but two drawbacks include need for intravenous (IV) contrast and dependence on radiologist expertise. The investigators expect that the combination of two other techniques, biparametric MRI (bpMRI) and Restriction Spectrum Imaging restriction score (RSIrs), will help non-expert radiologists achieve similar performance to expert radiologists using bpMRI or mpMRI for detection of csPCa, while avoiding the drawbacks that are present when using mpMRI.
Description
ART-Pro will be conducted in two phases (ART-Pro-1 and ART-Pro-2) and will evaluate bpMRI, mpMRI, and RSIrs (an advanced quantitative diffusion technique), for detection of csPCa. ART-Pro-1 will evaluate these techniques prospectively, by having each patients' MRI exam read by 2 expert radiologists, both using different subsets of the images to evaluate the different techniques. ART-Pro-1 will additionally evaluate RSIrs as a stand-alone quantitative biomarker. ART-Pro-2 will evaluate these same techniques retrospectively using radiologists of varying experience levels (novice, basic, and expe…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 18 years of age or older * Referred for mpMRI of the prostate for suspicion of prostate cancer * MRI is conducted using the standardized ART-Pro acquisition protocol Exclusion Criteria: * Currently incarcerated * Previous diagnosis of prostate cancer * Active non-prostate tumor(s) in structures of the body near the prostate * Previous prostate surgery * History of hip implant * Metal implants or implanted devices in the body or other criteria that are deemed to require deviation from the usual acquisition protocol or scanning procedures
Interventions
- Diagnostic TestRSI MRI
In ART-Pro-1, patients receive standard of care mpMRI, with addition of the RSI sequence, and subsets of the patients' images are read separately by two expert radiologists at the center, one of whom is the standard of care radiologist (Reader 1). Three research reports are generated using: bpMRI only (Reader 1), mpMRI (Reader 1), and bpMRI + RSIrs (Reader 2). The clinical report is submitted by Reader 1. Patients' future prostate cancer management will be recorded and used to evaluate the performance of the MRI techniques being tested.
Locations (5)
- University of California San DiegoSan Diego, California
- University of California, San FranciscoSan Francisco, California
- Massachusetts General HospitalBoston, Massachusetts
- Weill Cornell Medical CollegeNew York, New York
- Cambridge University Hospitals NHS Foundation TrustCambridge, Cambridgeshire