Recruiting

MRI

Sponsor:

UCLA

Code:

NCT06579417

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RSI MRI

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT06579417

Start date

Dec 15, 2023

Status verified date

Nov, 2024

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

ART-Pro-1

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Tyler Seibert, MD, PhD

858-246-2180tseibert@health.ucsd.edu

Locations

University of California San Diego

Recruiting

San Diego, California, United States, 92037

Contacts

Tyler M Seibert, MD, PhD

858-246-2180tseibert@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Nov 6, 2024

Last verified

Nov, 2024

Keywords

  • Prostate cancer
  • Multiparametric MRI
  • Biparametric MRI
  • Restriction Spectrum Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2024-11-06.