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

University of California San Diego

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Diagnostic Test: RSI MRI

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06579417

804875

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

ART-Pro-1

Treatment:

Diagnostic Test: RSI MRI