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

Conditions

• Prostate Carcinoma

Eligibility Criteria

Sex

MALE

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Biopsy of Prostate — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Computed Tomography — PROCEDURE
  Undergo PET/CT
• Flotufolastat F-18 Gallium — RADIATION
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT

Study Details

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 Dates

Start date

Nov 14, 2025

Status verified

Mar 2026

Primary completion

Jan 28, 2036

Completion

Jan 28, 2037

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Diagnostic (flotufolastat F-18 PET/CT)
  Patients receive flotufolastat F-18 IV and then, 50-100 minutes later, undergo PET/CT over 30 minutes. Within 6 months of PET/CT imaging, patients undergo PSMA PET/CT/US fusion biopsy and MRI/US fusion biopsy in a randomized order. Patients may undergo blood sample collection at screening and/or on study.

Primary Outcome Measure

Detection of high-grade cancer (grade group [GG] ≥ 2) [ Time Frame: At time of biopsy ]

Central Contacts

• Kyla Grunden
  310-206-7576
  [email protected]

Locations (1)

Find similar trials in Los Angeles, CA

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