NCT06579417

ART-Pro: Clinical Trial Evaluating Biparametric MRI and Advanced, Quantitative Diffusion MRI for Detection of Prostate Cancer

Advanced Restriction Imaging and Reconstruction Technology for Prostate MRI (ART-Pro)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	RSI 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.

Timeline

• Start date: 2023-12-15
• Primary completion: 2026-07-01
• Completion: 2029-07-01
• First posted: 2024-08-30
• Last updated: 2024-11-06

Locations

5 sites across 2 countries: United States, United Kingdom