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

RecruitingEARLY Phase 1Ages 18 Years - 90 YearsMaleJonsson Comprehensive Cancer Center
NCT07164027 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

  • Biopsy of Prostate
  • Biospecimen Collection
  • Computed Tomography
  • Flotufolastat F-18 Gallium
  • Positron Emission Tomography
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Where

1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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