ART-Pro: Clinical Trial Evaluating Biparametric MRI and Advanced, Quantitative Diffusion MRI for Detection of Prostate Cancer
Status
RECRUITING
Phase
Age
≥ 18 Years
Enrollments
500Conditions
Prostate CancerSummary
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.
Detailed 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 expert), and findings will be evaluated against the expertly created dataset from ART-Pro-1. Patients will be followed after initial enrollment for the purpose of extracting relevant medical outcomes, such as biopsy results or surgery pathology.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Tyler M Seibert, MD, PhD
- 858-246-2180
- [email protected]
Principal Investigator
- Tyler Seibert, MD, PhD
Eligibility Criteria
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
Study Plan
ART-Pro-1
DIAGNOSTIC_TEST:
RSI MRIDescription:
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.
Outcome Measures
Primary Outcome Measures
Proportion of patients diagnosed with a grade group u22652 prostate cancer on biopsy
Secondary Outcome Measures
Proportion of patients undergoing a biopsy that reveals no cancer or only grade group 1 prostate cancer
Timeline
Last Updated
November 6, 2024Start Date
August 30, 2024Today
May 12, 2025Completion Date ( Estimated )
July 1, 2029
Sponsors of this trial
Lead Sponsor
University of California, San DiegoCollaborating Sponsors
GE Healthcare, University of California, San Francisco, Massachusetts General Hospital, Weill Medical College of Cornell University, Cambridge University Hospitals NHS Foundation Trust
RECRUITING 
≥ 18 Years