Prostate Assessment with Restriction Spectrum Imaging (RSI) MRI

NCT ID: NCT04992728

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2026-11-01

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Restricted Spectrum Magnetic Resonance Imagining

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

RSI MRI; Diffusion MRI

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Tyler Seibert

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tyler Seibert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

UCSD Moores Cancer Center

La Jolla, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gerald Henderson, BA

Role: CONTACT

gehenderson@health.ucsd.edu

858-534-4811

Facility Contacts

Gerald Henderson, BA

Role: primary

gehenderson@ucsd.edu

858-822-5223

Other Identifiers

805338

Identifier Type: -

Identifier Source: org_study_id