RecruitingPhase 2NCT06865768

An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique

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


Sponsor

Emory University

Enrollment

90 participants

Start Date

Apr 18, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of imaging scan that combines a special PET scan (using a tracer called 18F-rhPSMA-7.3) with an MRI to more accurately guide prostate biopsies in men with suspected prostate cancer. **You may be eligible if...** - You are male and over 18 years old - Your doctor suspects you may have prostate cancer and you are scheduled for a biopsy - You are able to lie still for an MRI scan - You are able to give written consent **You may NOT be eligible if...** - You have been diagnosed with acute prostatitis (inflamed prostate) - You have a pacemaker or other metal implants that are unsafe for MRI - You have severe claustrophobia (fear of enclosed spaces) - You have severe kidney problems that prevent the use of MRI contrast dye Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFlotufolastat F-18 Gallium

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo TRUS-MR fusion biopsy

PROCEDUREMultiparametric Magnetic Resonance Imaging

Undergo mpMRI

PROCEDUREPositron Emission Tomography

Undergo PET

PROCEDURETransrectal Ultrasonography Guided Biopsy

Undergo TRUS-MR fusion biopsy


Locations(1)

Emory University Hospital

Atlanta, Georgia, United States

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NCT06865768


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