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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: RSI MRI

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Tyler Seibert, MD, PhD; Phone Number: 858-246-2180; Email: tseibert@health.ucsd.edu

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Not yet recruiting
      • Cambridge University Hospitals NHS Foundation Trust
      • Contact: Tristan Barrett, MD; Phone Number: 44 + 01223 805000; Email: tristan.barrett@nhs.net
• United States
  • California
    • San Diego, California, United States, 92037
      • Recruiting
      • University of California San Diego
      • Contact: Tyler M Seibert, MD, PhD; Phone Number: 858-246-2180; Email: tseibert@health.ucsd.edu
    • San Francisco, California, United States, 94143
      • Not yet recruiting
      • University of California, San Francisco
      • Contact: Sean A Woolen, MD; Phone Number: 415-353-2573; Email: sean.woolen@ucsf.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Not yet recruiting
      • Massachusetts General Hospital
      • Contact: Mukesh G Harisinghani, MD; Phone Number: 617-726-2000; Email: mharisinghani@mgh.harvard.edu
  • New York
    • New York, New York, United States, 10065
      • Not yet recruiting
      • Weill Cornell Medical College
      • Contact: Daniel JA Margolis, MD; Phone Number: 212-746-5454; Email: djm9016@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients referred for a multiparametric prostate MRI at any of the five participating sites, with a clinical suspicion of prostate cancer and that meet all the inclusion/exclusion criteria

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

ART-Pro-1

Diagnostic test: RSI 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients diagnosed with a grade group ≥2 prostate cancer on biopsy	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients undergoing a biopsy that reveals no cancer or only grade group 1 prostate cancer	6 months

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Massachusetts General Hospital; GE Healthcare; Weill Medical College of Cornell University; University of California, San Francisco; Cambridge University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Tyler Seibert, MD, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Prostate cancer; Multiparametric MRI; Biparametric MRI; Restriction Spectrum Imaging
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 804875

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes