Home › Prostate Cancer › NCT07164027
Comparing a New PSMA Imaging Agent to MRI for Detecting Prostate Cancer, BEACON Trial
Beacon: Prospective Assessment of Flotufolastat F 18 PSMA and MRI in the Diagnosis of Clinically Significant Prostate Cancer
Who can join
Ages 18 to 90 · Men
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
About the study
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.
What is being tested
- Biopsy of Prostate (procedure)
- Biospecimen Collection (procedure)
- Computed Tomography (procedure)
- Flotufolastat F-18 Gallium (radiation)
- Positron Emission Tomography (procedure)
Sponsor: Jonsson Comprehensive Cancer Center · Participants: 30 · Started: Nov 14, 2025
Contact the study team
- Kyla Grunden · Phone: 310-206-7576
Official record on ClinicalTrials.gov — NCT07164027
Locations in the U.S.
| California | UCLA / Jonsson Comprehensive Cancer Center, Los Angeles |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.