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.
Additional locations may be listed 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
