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Prostate CarcinomaEarly Phase 1NCT07164027

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

A Early Phase 1 study testing Biopsy of Prostate, Biospecimen Collection and Computed Tomography in people with Prostate Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 90 years, men only
Conditions the study is for
Prostate Carcinoma
What is being tested?
Biopsy of Prostate, Biospecimen Collection and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
14 Nov 2025to 28 Jan 2037
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kyla Grunden contact

310-206-7576

kgrunden@mednet.ucla.edu

United States1 site, 1 recruiting

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

    Kyla Grunden, 310-206-7576, kgrunden@mednet.ucla.edu

    Wayne Brisbane, MD

    Recruiting

Other trials in United States

About this study

Official title: Beacon: Prospective Assessment of Flotufolastat F 18 PSMA and MRI in the Diagnosis of Clinically Significant Prostate 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the detection rate of flotufolastat F 18 and magnetic resonance imaging (MRI) regions of interest for grade group 2 and greater prostate cancer.

SECONDARY OBJECTIVES:

  1. Evaluate the detection rate of incidental grade group (GG)1 prostate cancer (region of interest [ROI] benign, systematic GG1).

II. Evaluate the patient-level GG ≥ 2 detection rate for increasing standardized uptake value (SUV) and Prostate Imaging-Reporting and Data System (PI-RADS) score to determine if/when systematic biopsy may be omitted.

III. Evaluate the concordance between biopsy methods for intraprostatic tumor location (e.g., right versus [vs.] left vs. bilateral).

IV. Validate the MRI + prostate specific membrane antigen (PSMA)-positron emission tomography (PET) composite (P) score for prostate biopsy.

EXPLORATORY OBJECTIVES:

  1. Evaluate if MRI vs PSMA ROI detects more aggressive cancer clones based on the percentage of Gleason pattern 4 or 5.
  2. Compare the tumor volume of PSMA and MRI for men proceeding to focal therapy.

OUTLINE:

Patients receive flotufolastat F-18 intravenously (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/ultrasound (US) fusion biopsy and MRI/US fusion biopsy in a randomized order. Patients may undergo blood sample collection at screening and/or on study.

After completion of study intervention, patients are followed up within 3 months of their biopsy and then every 12 months for up to 10 years.

Being tested
Biopsy of Prostate, Biospecimen Collection, Computed Tomography, Flotufolastat F-18 Gallium, Positron Emission Tomography
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy of ProstateProcedure or surgery

    Also called Prostate Biopsy, Prostatic Biopsy

    Undergo biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT

  • Flotufolastat F-18 GalliumRadiation

    Also called (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

Study groups in NCT07164027
Study groupRoleWhat they receive
Diagnostic (flotufolastat F-18 PET/CT)ExperimentalPatients 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.
Receives: Procedure: Biopsy of Prostate; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: Flotufolastat F-18 Gallium; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detection of high-grade cancer (grade group [GG] ≥ 2)

    Results of prostate specific membrane antigen (PSMA)- and magnetic resonance imaging (MRI)-guided biopsy will be compared to the results of systematic biopsy in the same patient.

    Measured: At time of biopsy

Secondary outcomes (4)

  1. Proportion of subjects with incidental GG1 prostate cancer detected through systematic biopsy when the region of interest is benign on MRI and PSMA-positron emission tomography (PET)

    Measured: At time of biopsy

  2. Rate of detection of GG ≥ 2 prostate cancer in relation to increasing standardized uptake value and Prostate Imaging-Reporting and Data System scores

    Measured: At time of biopsy

  3. Percentage of cases where the intraprostatic tumor location identified by MRI-guided and PSMA-guided biopsies matches

    Measured: At time of biopsy

  4. Accuracy and predictive value of the MRI + PSMA-PET composite score for detecting clinically significant prostate cancer during biopsy

    Measured: At time of biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2025
  2. Study start14 Nov 2025
  3. Primary completion28 Jan 2036 (estimated)
  4. Study completion28 Jan 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07164027
Sponsor's protocol ID
24-1372
Other IDs
NCI-2025-05056
Status last verified
Mar 2026
First submitted
25 Aug 2025
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Biopsy of Prostate, Biospecimen Collection and Computed Tomography in people with Prostate Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kyla Grunden (310-206-7576, kgrunden@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection of high-grade cancer (grade group [GG] ≥ 2) (time frame: At time of biopsy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07164027.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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Clinical Trial NCT07164027 | AzTrials