Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around
Principal Investigator
by Tyler Seibert, MD, PhD
Headshot of Tyler Seibert
Tyler Seibert

Description

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.

Official Title

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

Details

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.

Keywords

Prostate Cancer, Multiparametric MRI, Biparametric MRI, Restriction Spectrum Imaging, Prostatic Neoplasms, RSI MRI, ART-Pro-1

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego accepting new patients
    San Diego California 92037 United States
  • University of California, San Francisco not yet accepting patients
    San Francisco California 94143 United States

Lead Scientist at UCSD

  • Tyler Seibert, MD, PhD
    Dr. Seibert is a clinical translational researcher working on imaging and genetics for cancer detection and treatment. More at SeibertLab.com.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06579417
Study Type
Observational
Participants
Expecting 500 study participants
Last Updated