Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Patients who have agreed to undergo an MRI and subsequent prostate needle biopsy will be approached to participate in the trial. The patient will undergo the prostate MRI as standard of care. The OnQ Prostate will be acquired at the same time as the standard of care MRI at no additional cost to the subject. The MRI images will be acquired using MRI equipment manufactured by 3 different companies, depending on which facility they have their imaging performed.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MRI imaging using Siemens MRI<br>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. | Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)<br>* An advanced imaging software that supports improved prostate cancer detection and diagnosis<br>* Other names: On-Q Prostate;|
| Other: MRI imaging using Phillips MRI<br>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. | Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)<br>* An advanced imaging software that supports improved prostate cancer detection and diagnosis<br>* Other names: On-Q Prostate;|
| Other: MRI imaging using General Electric (GE) MRI<br>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. | Other: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)<br>* An advanced imaging software that supports improved prostate cancer detection and diagnosis<br>* Other names: On-Q Prostate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RSM mapping value | 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. | Baseline to approximately 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Detection of prostate cancer, software application