RecruitingNCT06579417

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)

Sponsor

University of California, San Diego

Enrollment

500 participants

Start Date

Dec 15, 2023

Study Type

OBSERVATIONAL

Conditions

Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a specialized type of MRI scan called biparametric MRI — combined with advanced imaging technology — can better detect prostate cancer compared to standard MRI. The goal is to find cancer more accurately without needing as many unnecessary biopsies. **You may be eligible if...** - You are 18 or older - You have been referred for a prostate MRI because prostate cancer is suspected - Your MRI will be performed using the study's specific scanning method **You may NOT be eligible if...** - You are currently incarcerated - You have already been diagnosed with prostate cancer - You have another active cancer (other than prostate) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.