NCT06579417 ART-Pro: Clinical Trial Evaluating Biparametric MRI and Advanced, Quantitative Diffusion MRI for Detection of Prostate Cancer
| NCT ID | NCT06579417 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-12-15 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-12-15 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Tyler Seibert, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT06579417 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06579417 currently recruiting?
Yes, NCT06579417 is actively recruiting participants. Contact the research team at tseibert@health.ucsd.edu for enrollment information.
Where is the NCT06579417 trial being conducted?
This trial is being conducted at San Diego, United States, San Francisco, United States, Boston, United States, New York, United States and 1 additional location.
Who is sponsoring the NCT06579417 clinical trial?
NCT06579417 is sponsored by University of California, San Diego. The principal investigator is Tyler Seibert, MD, PhD at University of California, San Diego. The trial plans to enroll 500 participants.
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