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

Not Applicable

Not yet recruiting

• Conditions: Prostate Carcinoma

• Registration Number: NCT07164027
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief 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. 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

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-08-25
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Study Start: 2025-09-28
• Primary Completion: 2035-09-28
• Study Completion: 2036-09-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Detection of high-grade cancer (grade group [GG] ≥ 2)	At time of biopsy	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.

Secondary Outcome Measures

Name	Time	Method
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)	At time of biopsy
Rate of detection of GG ≥ 2 prostate cancer in relation to increasing standardized uptake value and Prostate Imaging-Reporting and Data System scores	At time of biopsy
Accuracy and predictive value of the MRI + PSMA-PET composite score for detecting clinically significant prostate cancer during biopsy	At time of biopsy
Percentage of cases where the intraprostatic tumor location identified by MRI-guided and PSMA-guided biopsies matches	At time of biopsy

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States