Prostate Assessment with Restriction Spectrum Imaging (RSI) MRI

NCT04992728 | Recruiting

• 1 other identifier: 805338
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inter-scan reliability

  30 days

Study Arms (1)

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

Interventions

Restricted Spectrum Magnetic Resonance Imagining 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.

Also known as: RSI MRI, Diffusion MRI

Male Prostate Patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: biological males with intact prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Tyler Seibert, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerald Henderson, BA

CONTACT

858-534-4811; gehenderson@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: November 2, 2021
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)