Evaluating MRI for Prostate Cancer Assessment
Quantitative Diffusion MRI for Prostate Cancer Detection and Monitoring
University of California, San Diego · NCT04992728
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of California, San Diego (other) |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT04992728 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 and older with histologically confirmed adenocarcinoma of the prostate who are scheduled for radical prostatectomy.
Not a fit: Patients who have received prior treatment for prostate cancer or have contraindications to MRI will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
La Jolla, California
- 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
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.
Conditions: Prostate Cancer, prostatectomy