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

Description

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.

Conditions

Prostate Cancer

Study Overview

Study Details

Study overview

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.

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

San Diego

University of California San Diego, San Diego, California, United States, 92037

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

New York

Weill Cornell Medical College, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Diego,

Tyler Seibert, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

2029-07