Status:
RECRUITING
Comparing a New PSMA Imaging Agent to MRI for Detecting Prostate Cancer, BEACON Trial
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Blue Earth Diagnostics
Conditions:
Prostate Carcinoma
Eligibility:
MALE
18-90 years
Phase:
EARLY_PHASE1
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...
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 OBJECTIVE...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 28 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 28 2037
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07164027
Start Date
January 28 2026
End Date
January 28 2037
Last Update
November 14 2025
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095