Prostate Cancer
Conditions
Keywords
Detection of prostate cancer, software application
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.
Interventions
OTHERRestricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)
An advanced imaging software that supports improved prostate cancer detection and diagnosis
Sponsors
National Cancer Institute (NCI)
University of California, San Diego
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
MALE
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactMichael A Liss, MD, PhD
Backup ContactJessica Warbrick, ND
Outcome results
None listed