This phase IV trial studies how well 18F-fluciclovine positron emission tomography (PET)/computed tomography (CT) works in detecting prostate-specific membrane antigen (PSMA)-low castration resistant and neuroendocrine prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). PSMA is a protein found on the surface of some prostate cancers and can be detected by PSMA imaging scans. Prostate cancers can have different levels of PSMA. 18F-fluciclovine is a radioactive drug used to measure tumor growth. PET/CT uses x-rays to take pictures inside the body. 18F-fluciclovine PET-CT imaging scans may help doctors detect and determine the extent of metastatic PSMA-low castration resistant and neuroendocrine prostate cancer in the body.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06062745.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer InstituteStatus: Active
Contact: Heather Jacene
Brigham and Women's HospitalStatus: Active
Contact: Heather Jacene
PRIMARY OBJECTIVES:
I. To determine if PSMA-negative metastatic prostate cancer lesions have a higher percentage of lesions with fluciclovine F18 (18F-fluciclovine) uptake compared to PSMA-positive lesions. (Cohort A)
II. To determine if PSMA-negative and PSMA-positive metastatic prostate cancer lesions have different percentages of lesions with 18F-fluciclovine uptake in patients with neuroendocrine prostate cancer (NEPC) prostate cancer. (Cohort B)
SECONDARY OBJECTIVES:
I. To correlate semi-quantitative measures of PSMA and 18F-fluciclovine uptake on PET/CT imaging in PSMA-low disease and NEPC. (Both cohorts)
II. To correlate PSMA and 18F-fluciclovine PET imaging features with tumor molecular features including PSMA expression, amino acid transporter expression, androgen receptor (AR) and neuroendocrine (NE) signaling markers, and genomic /transcriptomic and other molecular alterations. (Both cohorts)
III. To report baseline clinical features associated with PSMA/18F-fluciclovine PET imaging in patients with PSMA-low castration-resistant prostate cancer (CRPC) and NEPC including serum prostate-specific antigen (PSA), sites of metastases, prior therapies, as well as response and radiographic progression free survival on subsequent therapies and overall survival. (Both cohorts)
OUTLINE:
Patients receive 18F-fluciclovine intravenously (IV) and undergo a PET/CT scan over 1 hour. Patients with NEPC may undergo a standard of care (SOC) gallium Ga 68 gozetotide (68Ga-PSMA) PET/CT on study. Patients also undergo blood sample collection throughout the trial.
After completion of study, patients are followed up every 3 months.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorHeather Jacene
