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Prostate Cancer Imaging in Early Detection (IMAGINED Trial)

This study is testing if a special type of MRI software, called Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI), can help doctors find prostate cancer more accurately during an MRI-guided biopsy. Researchers want to see if this advanced imaging improves how well prostate cancer is detected compared to standard MRI readings alone. You might be able to join if you are a man selected for an MRI-fusion prostate needle biopsy and have not had prostate cancer before or received prior treatment. The study aims to see if the RSI-MRI software can improve the accuracy of detecting important prostate cancers. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 225 men. It is a Phase 2, prospective, non-randomized clinical trial.
What's involved
You would undergo an MRI and a subsequent prostate needle biopsy. The study will measure RSM mapping values from baseline to approximately 9 months.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement for the study is taken from baseline up to approximately 9 months.

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NCT05882253

Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)

Recruiting
NAAll AgesInterventionalDiagnostic
University of California, San Diego
~225 participants
Updated 2025-07-17 on ClinicalTrials.gov
What's tested:Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
RSM mapping value
Measured over Baseline to approximately 9 months

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Michael A Liss, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Diego

Who to contact

Michael A Liss, MD, PhD
[email protected]
858-249-1240
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • RSM mapping valueBaseline to approximately 9 months

    Radiologists will report a standard Prostate Imaging, Reporting, and Data System (PI-RADS) and document the RSM values associated with each lesion. Change in value will be reported from baseline to routine biopsy follow-up.