Prostate Assessment with Restriction Spectrum Imaging (RSI) MRI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Restricted Spectrum Magnetic Resonance Imagining.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Quantitative Diffusion MRI for Prostate Cancer Detection and Monitoring
Overview
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.
Interventions
- Other Restricted Spectrum Magnetic Resonance Imagining
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.
Primary outcome measures
- Detection of grade group ≥2 prostate cancer on histopathology [Time frame: 30 days]
Secondary outcome measures (1)
- Inter-scan reliability [Time frame: 30 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- UCSD Moores Cancer Center — La Jolla
Identifiers
NCT: NCT04992728 · 805338