Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)

Not Applicable

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT05882253
• Lead Sponsor: University of California, San Diego

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-31
• Study Start: 2023-12-04
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Primary Completion: 2027-12
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 225

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
RSM mapping value	Baseline 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.

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States