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RecruitingEarly Phase 1

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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 years
  • Procedures mentioned: CT scans, Biopsies, X-rays, Ultrasound, MRI scans, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "CT utilizes X-rays that track the body from the outside."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares a new PET/CT scan using the radioactive agent flotufolastat F 18 with MRI to guide prostate biopsies, which take small tissue samples. It tests how often each method finds prostate cancer. It is for men ages 18–90 who have at least one area on a recent MRI that may be cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a man age 18–90 when you join.
  • An MRI done within the past 12 months shows at least one area rated PI-RADS 3–5, meaning cancer may be present.

Who can't join

  • You cannot safely have a PET/CT scan with flotufolastat F 18.
  • You cannot safely have a prostate biopsy guided by ultrasound, which uses sound waves to make images.
  • You have had treatment for prostate cancer.
  • You cannot stop taking blood thinners for 7 days before the biopsy.
  • You received any experimental agents within 42 days before the first study dose.
  • You cannot understand or follow study instructions or requirements.
  • You cannot complete the scans or biopsy for any reason, such as a strong fear of enclosed spaces, trouble lying still, or being unable to keep your arms raised.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

CA