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RECRUITING
NCT07164027
EARLY_PHASE1

Comparing a New PSMA Imaging Agent to MRI for Detecting Prostate Cancer, BEACON Trial

Sponsor: Jonsson Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

This early phase I trial evaluates whether a new imaging technique using flotufolastat F 18 (a type of prostate specific membrane antigen \[PSMA\] imaging agent) with positron emission tomography (PET)/computed tomography (CT) can be used to guide targeted prostate biopsies in men with prostate cancer. Flotufolastat F 18 is a radioactive imaging agent that binds to prostate tumor cells that express PSMA. This allows for visualization of PSMA-expressing tumor cells on imaging scans such as PET/CT. 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, flotufolastat F 18. Because prostate cancer takes up flotufolastat F 18, it can be seen with PET. CT utilizes X-rays that track the body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the body. The PET/CT scanner combines the PET and the CT scanners into a single device. A targeted prostate biopsy refers to using advanced imaging for guidance when taking samples (biopsies) of the prostate. This method can fuse (combine) PET/CT images with real-time ultrasound during a prostate biopsy. PSMA PET/CT scans have the potential for guiding prostate biopsies. Using image fusion technology, they can increase detection of prostate cancer by providing anatomical information and guidance during a prostate biopsy. Improved detection of prostate cancer using PSMA PET/CT guidance may better inform men and their clinicians about prostate cancer risk and management. This study attempts to determine how often prostate cancer is found when using PSMA PET/CT scan images during a biopsy versus the conventional magnetic resonance imaging-guidance.

Official title: Beacon: Prospective Assessment of Flotufolastat F 18 PSMA and MRI in the Diagnosis of Clinically Significant Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-11-14

Completion Date

2037-01-28

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

PROCEDURE

Biopsy of Prostate

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Computed Tomography

Undergo PET/CT

RADIATION

Flotufolastat F-18 Gallium

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States