Prospective Phase II Validation of the Performance of a Prostate-Specific Membrane Antigen (PSMA) Radiotracer for Positron Emission Tomography-Multiparametric Magnetic Resonance (PET-mpMR) Imaging to Target Prostate Biopsy Via Transrectal Ultrasound (TRUS) -Magnetic Resonance Imaging (MRI) Fusion Technique

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial evaluates an imaging technique called 18F-rhPSMA-7.3 positron emission tomography (PET)-multiparametric (mp) magnetic resonance imaging (MRI) in identifying tumor tissue in men suspected to have prostate cancer. This clinical trial also seeks to determine if the abnormal tissue identified during imaging represents the tumor tissue removed during transrectal ultrasound-magnetic resonance imaging (TRUS-MR) fusion biopsy of the prostate. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-rhPSMA-7.3. Because some tumors take up 18F-rhPSMA-7.3 it can be seen with PET. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. Standard of care imaging for prostate cancer includes mpMRI, which is the combination of multiple magnetic resonance techniques, including diffusion weighted imaging, dynamic contrast-enhanced imaging, and spectroscopy, to achieve an image that will allow for better identification of tumor size and location, as well as possibly identifying tumor spread and aggressiveness. However, mpMRI may not be as effective in identifying prostate tumors that are clinically significant. A TRUS-MR biopsy involves using both ultrasound and MRI scans to locate abnormal areas in the prostate. An 18F-rhPSMA-7.3 PET-mpMRI may be more effective than mpMRI alone in identifying tumor tissue and may increase the accuracy of TRUS-MRI fusion biopsies in men suspected of having prostate cancer.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Male subjects aged \> 18 years

• Patients with suspected prostate cancer who will have prostate biopsy for confirmation

• Ability to lie still for MRI scanning

• Patients must be able to provide written informed consent

Locations
United States
Georgia
Emory University Hospital
RECRUITING
Atlanta
Contact Information
Primary
David M. Schuster, MD, FACR
dschust@emory.edu
404-712-4859
Time Frame
Start Date: 2025-04-18
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 90
Treatments
Experimental: Diagnostic (18F-rhPSMA-7.3 PET, mpMRI, TRUS-MR fusion biopsy)
Patients receive 18F-rhPSMA-7.3 IV and, 50 minutes later, undergo PET over 30 minutes at the time of SOC mpMRI. Patients may also undergo standard of care TRUS-MR fusion biopsy of targets identified on SOC mpMRI.
Related Therapeutic Areas
Sponsors
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)
Leads: Emory University

This content was sourced from clinicaltrials.gov

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