Prostate Assessment with Restriction Spectrum Imaging (RSI) MRI

Recruiting

• Conditions: Prostate Cancer
• Interventions: Other: Restricted Spectrum Magnetic Resonance Imagining

• Registration Number: NCT04992728
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

Study Timeline

• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-05
• Study Start: 2021-11-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Male Prostate Patients	Restricted Spectrum Magnetic Resonance Imagining	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.

Primary Outcome Measures

Name	Time	Method
Detection of grade group ≥2 prostate cancer on histopathology	30 days	To determine an optimal quantitative dMRI technique for csPCa detection, we will implement an expanded dMRI protocol that will permit exploration of six different approaches, each with published evidence of advantages over conventional ADC. Accuracy will be evaluated using histopathology as the gold standard.

Secondary Outcome Measures

Name	Time	Method
Inter-scan reliability	30 days	Reliability is a critical feature of quantitative imaging biomarkers. Prostate MRI is known to vary with physiologic conditions, such as bowel activity, bowel/bladder filling, and recency of ejaculation(5). Patients planning to undergo prostatectomy (to permit whole-mount histopathology correlation) will be invited to consent to a second MRI scan on a different date, within approximately 30 days of the first scan (to avoid meaningful change in any tumor). The across-date reproducibility coefficient will be calculated for each metric

Trial Locations

Locations (1)

UCSD Moores Cancer Center; 🇺🇸 La Jolla, California, United States