Evaluating advanced MRI techniques for detecting prostate cancer
Advanced Restriction Imaging and Reconstruction Technology for Prostate MRI (ART-Pro)
This study is testing new MRI techniques to see if they can help doctors better detect significant prostate cancer in men without needing special contrast dyes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 5 sites (San Diego, California and 4 other locations) |
| Trial ID | NCT06579417 on ClinicalTrials.gov |
What this trial studies
This multicenter, multinational trial aims to assess the effectiveness of advanced MRI techniques, specifically biparametric MRI (bpMRI) and Restriction Spectrum Imaging (RSIrs), in detecting clinically significant prostate cancer (csPCa). The study will enroll 500 participants across five clinical centers, comparing these new methods to the current standard, multiparametric MRI (mpMRI). The goal is to enable non-expert radiologists to achieve detection performance comparable to experts while avoiding the limitations associated with mpMRI, such as the need for intravenous contrast. Participants will be followed for relevant medical outcomes, including biopsy results and surgical pathology.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older who are referred for mpMRI due to suspicion of prostate cancer.
Not a fit: Patients with a previous diagnosis of prostate cancer or those with active tumors near the prostate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection of prostate cancer, making screening more accessible and effective.
How similar studies have performed: Other studies have shown promise in using advanced MRI techniques for cancer detection, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Diego, California and 4 other locations
- University of California San Diego — San Diego, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Not_yet_recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Weill Cornell Medical College — New York, New York, United States (Not_yet_recruiting)
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, Cambridgeshire, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Tyler Seibert, MD, PhD — University of California, San Diego
- Study coordinator: Tyler Seibert, MD, PhD
- Email: tseibert@health.ucsd.edu
- Phone: 858-246-2180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.