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

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.

Conditions

• Prostate Carcinoma

Interventions

DRUG

Flotufolastat F-18 Gallium

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo TRUS-MR fusion biopsy

PROCEDURE

Multiparametric Magnetic Resonance Imaging

Undergo mpMRI

PROCEDURE

Positron Emission Tomography

Undergo PET

PROCEDURE

Transrectal Ultrasonography Guided Biopsy

Undergo TRUS-MR fusion biopsy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• David M Schuster, MD, FACR · Emory University Hospital/Winship Cancer Institute

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-18

Primary Completion

2028-12-31

Completion

2029-12-31

FDA Drug

Yes

Countries

• United States

Study Locations