Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)

University of California San Diego

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05882253

HSC20220897H

R01CA279667 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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225 participants in 3 patient groups

MRI imaging using Siemens MRI

Other group

Description:

Participants enrolled will undergo routine Magnetic Resonance Imaging (MRI) to obtain Restricted Spectrum Mapping (RSM). These sequences are acquired at the same time as standard multi-parametric MRI sequences. Second post-processing software then transfers the acquired RSI images from DICOM format and applies a color-coded image that is then overlayed onto the anatomic T2 image.

Treatment:

Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)

MRI imaging using Phillips MRI

Other group

Description:

Participants enrolled will undergo routine MRI to obtain RSM. These sequences are acquired at the same time as standard multi-parametric MRI sequences. Second post-processing software then transfers the acquired RSI images from DICOM format and applies a color-coded image that is then overlayed onto the anatomic T2 image.

Treatment:

Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)

MRI imaging using General Electric (GE) MRI

Other group

Description:

Participants enrolled will undergo routine MRI to obtain RSM. These sequences are acquired at the same time as standard multi-parametric MRI sequences. Second post-processing software then transfers the acquired RSI images from DICOM format and applies a color-coded image that is then overlayed onto the anatomic T2 image.

Treatment:

Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)