Recruiting

Restriction Spectrum Imaging

Sponsor:

UCLA

Code:

NCT04992728

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Restricted Spectrum Magnetic Resonance Imagining

Study Details

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

Study ID

NCT04992728

Start date

Nov 2, 2021

Status verified date

Feb, 2025

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Detection of grade group ≥2 prostate cancer on histopathology [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Gerald Henderson, BA

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

Locations

UCSD Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Gerald Henderson, BA

858-822-5223gehenderson@ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Feb 6, 2025

Last verified

Feb, 2025

Keywords

  • prostatectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-02-06.