Evaluating MRI for Prostate Cancer Assessment
Official title: Quantitative Diffusion MRI for Prostate Cancer Detection and Monitoring
Run by University of California, San Diego · NCT04992728 · Data updated 2026-11-12
This study is testing a new type of MRI scan to see if it can better predict serious prostate cancer in men who already have the disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 100 (estimated) |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Status | Recruiting |
| Started | November 2, 2021 |
| Main results expected | November 1, 2025 |
| Study ends | November 1, 2026 |
| Registry record updated | February 6, 2025 |
| Trial ID | NCT04992728 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males aged 18 and older with histologically confirmed adenocarcinoma of the prostate who are scheduled for radical prostatectomy.
✕Probably not a fit
Patients who have received prior treatment for prostate cancer or have contraindications to MRI will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will enroll 40 male participants with confirmed prostate cancer to undergo two diffusion magnetic resonance imaging (MRI) scans within 30 days. The study aims to evaluate the reliability of advanced MRI models in predicting clinically significant prostate cancer by comparing results from multiple b-values and echo times. The focus is on using a multicompartment diffusion MRI model, known as Restriction Spectrum Imaging (RSI), to provide a more accurate assessment of tumor cellularity compared to standard imaging techniques. Participants will have their imaging results correlated with histopathological findings from routine clinical care.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of prostate cancer detection and improve treatment planning for patients.
How similar studies have gone: While advanced imaging techniques are being explored, the specific application of RSI in this context is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male, aged ≥18 years, with histologically confirmed adenocarcinoma of the prostate * Has already undergone prostate MRI and/or scheduled to undergo clinically indicated radical prostatectomy (to permit whole-mount histopathology correlation). * Intended treatment and follow-up according to standard of care for prostate cancer * In good general health as evidenced by medical history and ECOG performance status 0-2 * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: * Prior treatment for prostate cancer (cryotherapy, high frequency focused ultrasound, prostatectomy) * Hip prosthesis * Contraindication to MRI, per institutional requirements * Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Where it's running
-
UCSD Moores Cancer Center
La Jolla, California, United States Recruiting
Study contacts
- Principal investigator: Tyler Seibert, MD, PhD — University of California, San Diego
- Study coordinator: Gerald Henderson, BA
- Email: gehenderson@health.ucsd.edu
- Phone: 858-534-4811
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.