Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)

Purpose

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.

Condition

  • Prostate Cancer

Eligibility

Eligible Ages
All ages
Eligible Genders
Male
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Intervention 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.
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
MRI imaging using Siemens MRI 		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)
    An advanced imaging software that supports improved prostate cancer detection and diagnosis
    Other names:
    • On-Q Prostate
Other
MRI imaging using Phillips MRI 		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)
    An advanced imaging software that supports improved prostate cancer detection and diagnosis
    Other names:
    • On-Q Prostate
Other
MRI imaging using General Electric (GE) MRI 		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)
    An advanced imaging software that supports improved prostate cancer detection and diagnosis
    Other names:
    • On-Q Prostate

Recruiting Locations

The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
San Antonio, Texas 78229
Contact:
Michael Liss, MD
210-567-5676
Liss@uthscsa.edu

University Health System
San Antonio, Texas 78229
Contact:
Michael A Liss, MD, PhD
210-567-0548
Liss@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Michael A Liss, MD, PhD
(210) 567-0548
Liss@uthscsa.edu

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.