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NCT Number: NCT06579417

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RSI MRI

Diagnostic Test

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.

Primary outcomes

  1. Proportion of patients diagnosed with a grade group ≥2 prostate cancer on biopsy

    Time frame: 6 months

Secondary outcomes

  1. Proportion of patients undergoing a biopsy that reveals no cancer or only grade group 1 prostate cancer

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Tyler Seibert, MD, PhD

CONTACT

[email protected]

858-246-2180

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Cambridge University Hospitals NHS Foundation Trust
  • GE Healthcare
  • Massachusetts General Hospital
  • University of California, San Francisco
  • Weill Medical College of Cornell University

Registry information

Official study title

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

Acronym: ART-Pro

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Aug 30, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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