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

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

Conditions2

Locations4 sites

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