Prostate Assessment With Restriction Spectrum Imaging (RSI) MRI
Status
RECRUITING
Phase
Age
≥ 18 Years
Enrollments
100Conditions
Prostate CancerSummary
This single-center study will enroll 40 male participants to complete 2 diffusion magnetic resonance images within 30 days of each other.
Detailed Description
Participants will undergo prostate MRI using a range of b-values and echo times. 40 participants will be invited to complete two such scans within 30 days of each other to evaluate reliability across time. Several advanced MRI models will be applied to the data, and the models will be assessed for accurate prediction of grade group ≥2 prostate cancer on histopathology, obtained through routine clinical care. We hypothesize that advanced, multi-compartment dMRI will yield a reliable, quantitative metric that is superior to standard ADC for detection of csPCa.
RSI is a multicompartment model of diffusion MRI that uses data acquired at multiple b-values to distinguish varied diffusion speeds (restricted intracellular, hindered extracellular, and approximately free diffusion). The relative contributions of each compartment are estimated for each voxel in the imaging field of view. RSI cellularity index is a normalized parameter reflecting the contribution of very slow diffusion that is associated with tumor cellularity.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Gerald Henderson, BA
- 858-822-5223
- [email protected]
Principal Investigator
- Tyler Seibert, MD, PhD
Eligibility 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.
Study Plan
Male Prostate Patients
Adult male patients with fair to good performance status and who (1) have undergone an MRI of the prostate for suspected or known prostate cancer and/or (2) are planning to undergo radical prostatectomy for prostate cancer.
OTHER:
Restricted Spectrum Magnetic Resonance ImaginingDescription:
Restriction Spectrum Magnetic Resonance Imaging (RS-MRI), which uses magnetism instead of x-rays to build up a picture of the inside of the body. The scan is completely painless but can be rather noisy and requires the patient to lie very still inside the center of a large, doughnut-shaped magnet for approximately 30-60 minutes complete the imaging.
Outcome Measures
Primary Outcome Measures
Detection of grade group u22652 prostate cancer on histopathology
Secondary Outcome Measures
Inter-scan reliability
Timeline
Last Updated
January 26, 2024Start Date
August 5, 2021Today
February 5, 2025Completion Date ( Estimated )
November 1, 2026
Sponsors of this trial
Lead Sponsor
University of California, San Diego
RECRUITING 
21 - 64 Years