Clinical trial NCT05882253: Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)
Official title: Validation, Calibration, and Translation of Restriction Spectrum Imaging Signal Maps to Enhance MRI Diagnostic Capabilities in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Detection of prostate cancer
software application
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-05-31
Enrollment: 225
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: RSM mapping value
timeFrame: Baseline to approximately 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Audie Murphie VA
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
state: Texas
city: San Antonio
country: United States
facility: University Health System
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Michael A Liss, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: