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

Recruiting now · Early Phase 1

Conditions studied: Prostate Carcinoma

In brief

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.

Key facts

Study ID

NCT07164027

Run by

Jonsson Comprehensive Cancer Center

People needed

30

Starts

2025-11-14

Expected to finish

2037-01-28

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men aged 18-90 at study enrollment
• Have at least one PI-RADS 3-5 lesion on MRI within the 12 months prior to enrollment

You may not qualify if…

• Contraindication to flotufolastat F 18 PET CT
• Contraindication to ultrasound-guided prostate biopsy
• Previous treatment of prostate cancer
• Unable to discontinue blood thinners for 7 days prior to biopsy
• Any investigational agents within 42 days prior to the day of the first dose
• Not able to understand and to follow study instructions and requirements. This also includes the inability to complete the study imaging and or biopsy procedures due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time, any condition that precludes raised arms position)

Where it is running

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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