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)
1 other identifier
observational
500
2 countries
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2023
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2023
CompletedFirst Submitted
Initial submission to the registry
August 20, 2024
CompletedFirst Posted
Study publicly available on registry
August 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
November 6, 2024
November 1, 2024
2.5 years
August 20, 2024
November 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients diagnosed with a grade group ≥2 prostate cancer on biopsy
6 months
Secondary Outcomes (1)
Proportion of patients undergoing a biopsy that reveals no cancer or only grade group 1 prostate cancer
6 months
Study Arms (1)
ART-Pro-1
Interventions
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.
Eligibility Criteria
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
You may qualify if:
- 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Diegolead
- GE Healthcarecollaborator
- University of California, San Franciscocollaborator
- Massachusetts General Hospitalcollaborator
- Weill Medical College of Cornell Universitycollaborator
- Cambridge University Hospitals NHS Foundation Trustcollaborator
Study Sites (5)
University of California San Diego
San Diego, California, 92037, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Related Publications (1)
Baxter MT, Conlin CC, Bagrodia A, Barrett T, Bartsch H, Brau A, Cooperberg M, Dale AM, Guidon A, Hahn ME, Harisinghani MG, Javier-DesLoges JF, Kamran SC, Kane CJ, Kuperman JM, Margolis DJA, Murphy PM, Nakrour N, Ohliger MA, Rakow-Penner R, Shabaik A, Simko JP, Tempany CM, Wehrli N, Woolen SA, Zou J, Seibert TM. Advanced Restriction Imaging and Reconstruction Technology for Prostate Magnetic Resonance Imaging (ART-Pro): A Study Protocol for a Multicenter, Multinational Trial Evaluating Biparametric Magnetic Resonance Imaging and Advanced, Quantitative Diffusion Magnetic Resonance Imaging for the Detection of Prostate Cancer. Eur Urol Open Sci. 2024 Dec 20;71:132-143. doi: 10.1016/j.euros.2024.12.003. eCollection 2025 Jan.
PMID: 39811103DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tyler Seibert, MD, PhD
University of California, San Diego
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 20, 2024
First Posted
August 30, 2024
Study Start
December 15, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2029
Last Updated
November 6, 2024
Record last verified: 2024-11