Prostate Assessment With Restriction Spectrum Imaging (RSI) MRI

Prostate Cancer Clinical Trial

Official title:

Quantitative Diffusion MRI for Prostate Cancer Detection and Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04992728
• Other study ID #: 805338
• Status: Recruiting
• Start date: November 2, 2021
• Est. completion date: November 1, 2026

Study information

• Verified date: January 2024
• Source: University of California, San Diego
• Contact: Gerald Henderson, BA
• Phone: 858-534-4811
• Email: gehenderson[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	UCSD Moores Cancer Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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