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

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06579417
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 15, 2023
Status verified
Nov 2024
Primary completion
Jul 31, 2026
Completion
Jul 31, 2029

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: ART-Pro-1

Primary Outcome Measure

Proportion of patients diagnosed with a grade group ≥2 prostate cancer on biopsy [ Time Frame: 6 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California San DiegoSan DiegoCalifornia92037
Tyler M Seibert, MD, PhD
[email protected]
858-246-2180
University of California, San FranciscoSan FranciscoCalifornia94143
Sean A Woolen, MD
[email protected]
415-353-2573
Massachusetts General HospitalBostonMassachusetts02114
Mukesh G Harisinghani, MD
[email protected]
617-726-2000
Weill Cornell Medical CollegeNew YorkNew York10065
Daniel JA Margolis, MD
[email protected]
212-746-5454

Find similar trials in San Diego, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California San Diego· San Diego, CAUniversity of California, San Francisco· San Francisco, CAMassachusetts General Hospital· Boston, MAWeill Cornell Medical College· New York, NY

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