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

NCT ID: NCT07164027

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-28

Study Completion Date

2037-01-28

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVE:

I. 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:

I. 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.

Conditions

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Prostate Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Nuclear medicine physicians will initially be blinded to MRI findings while interpreting and outlining the PSMA PET/CT.

Study Groups

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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.

Group Type EXPERIMENTAL

Biopsy of Prostate

Intervention Type PROCEDURE

Undergo biopsy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

Computed Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Flotufolastat F-18 Gallium

Intervention Type RADIATION

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Interventions

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Biopsy of Prostate

Undergo biopsy

Intervention Type PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

Intervention Type PROCEDURE

Computed Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Flotufolastat F-18 Gallium

Given IV

Intervention Type RADIATION

Positron Emission Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Other Intervention Names

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Prostate Biopsy Prostatic Biopsy Biological Sample Collection Biospecimen Collected Specimen Collection CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan tomography (18F)-rhPSMA-7.3 18F-rhPSMA-7.3 18FrhPSMA-7.3 F-18-rhPSMA-7.3 Fluorine F 18 Radiohybrid PSMA-7.3 Fluorine F 18 rhPSMA-7.3 Fluorine-18 rhPSMA-7.3 Posluma rhPSMA-7.3 (18F) Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography PT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Blue Earth Diagnostics

INDUSTRY

Sponsor Role collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wayne Brisbane

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

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UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

Central Contacts

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Kyla Grunden

Role: CONTACT

Phone: 310-206-7576

Email: [email protected]

Facility Contacts

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Kyla Grunden

Role: primary

Other Identifiers

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NCI-2025-05056

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-1372

Identifier Type: -

Identifier Source: org_study_id