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

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:

• Evaluate if MRI vs PSMA ROI detects more aggressive cancer clones based on the percentage of Gleason pattern 4 or 5.
• 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.

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)