Summary

Eligibility
for males (full criteria)
Location
at La Jolla, California
Dates
study started
study ends around
Principal Investigator
by Michael A Liss, MD, PhD

Description

Summary

The researchers hope to learn if specific types of MRI software and techniques can help improve early prostate cancer detection at time of a MRI-guided prostate biopsy.

Official Title

Validation, Calibration, and Translation of Restriction Spectrum Imaging Signal Maps to Enhance MRI Diagnostic Capabilities in Prostate Cancer

Details

A phase 2 prospective, interventional, non-randomized clinical trial design to investigate whether Restricted Spectrum Maps (RSM) attained from RSI-MRI (On-Q Prostate) improves PI-RADS accuracy compared to PI-RADS alone for the detection of clinically significant prostate cancer. Patients who have agreed to undergo an MRI and subsequent prostate needle biopsy will be approached to participate in the trial.

The aims of the study are as follows:

Goal 1. Validate RSI-MRI imaging biomarker performance using a prospective clinical trial.

Goal 2. Calibrate the RSM values across different MRI scanner manufacturers. Goal 3. Translate RSI using a net clinical benefit model.

Keywords

Prostate Cancer, Detection of prostate cancer, software application, Prostatic Neoplasms, Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI), MRI imaging using Siemens MRI, MRI imaging using Phillips MRI, MRI imaging using General Electric (GE) MRI

Eligibility

You can join if…

Open to males

  • Selected to undergo an MRI-fusion prostate needle biopsy of the prostate.
  • Able to provide informed consent

You CAN'T join if...

  • prior diagnosis of prostate cancer (Grade Group >1)
  • metastatic prostate cancer
  • prior prostate cancer treatment
  • contraindication to prostate biopsy (e.g., on anticoagulation that cannot be safely discontinued)
  • inability to undergo MRI (e.g., too large to be accommodated in a scanner or with an implant incompatible with MRI).
  • Bilateral hip replacement
  • Unable to provide informed consent.

Location

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States

Lead Scientist at UCSD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05882253
Study Type
Interventional
Participants
Expecting 225 study participants
Last Updated