Prostate Assessment with Restriction Spectrum Imaging (RSI) MRI

Quantitative Diffusion MRI for Prostate Cancer Detection and Monitoring

This single-center study will enroll 40 male participants to complete 2 diffusion magnetic resonance images within 30 days of each other.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Restricted Spectrum Magnetic Resonance Imagining

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Gerald Henderson, BA; Phone Number: 858-534-4811; Email: gehenderson@health.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • UCSD Moores Cancer Center
      • Contact: Gerald Henderson, BA; Phone Number: 858-822-5223; Email: gehenderson@ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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 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.; Other Names: RSI MRI; Diffusion MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of grade group ≥2 prostate cancer on histopathology	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-scan reliability	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	30 days

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Tyler Seibert, MD, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: prostatectomy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 805338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No