This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of advanced prostate cancer that either has low prostate-specific membrane antigen (PSMA) expression or has neuroendocrine features.
The name of the study interventions are:
* 18F-fluciclovine-PET/CT scan * Two research blood collections
Participants must have histologically confirmed prostate cancer that is metastatic and one of the following: CRPC with PSMA-low disease defined by whole-body SUVmean ≤ 10 determined by standard-of-care 68Ga-PSMA-11 PET/CT imaging with at least 5 metastatic lesions OR NEPC pathology based on tumor biopsy. This may include morphology consistent with small cell carcinoma or mixed adenocarcinoma/NE features and/or IHC staining for NE markers. Participants should have at least 5 metastatic lesions.
Must have either already had standard of care 68Ga-PSMA PET/CT scan or be planned for 68Ga-PSMA PET/CT scan before or after the planned 18F-fluciclovine-PET/CT.
Age ≥18 years. Since no dosing or adverse event data are currently available on the use of 18F-fluciclovine in participants <18 years of age, and most prostate cancer occurs in the adult population, children are excluded from this study but will be eligible for future pediatric trials.
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
Participants with other known malignancy requiring treatment
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Severe claustrophobia
Single group
18F-fluciclovine
Drug18F-fluciclovine is a radiotracer targeting amino-acid transporters.Radiotracers are compounds or drugs that are attached to small amounts of a radioactive substance to make images of processes that are happening in the body
PET/CT
DevicePositron emission tomography/computed tomography (PET/CT) uses small amounts of radioactive materials called radiotracers, a special camera and a computer to help evaluate organ and tissue functions.
Fluciclovine and PSMA Uptake in PSMA Positive Tumors
Number of 18F-fluciclovine positive lesions in PSMA-positive tumors on PET Number of fluciclovine positive tumors that are PSMA-negative
Fluciclovine and PSMA Uptake in PSMA Negative Tumors
Number of 18F-fluciclovine positive lesions in PSMA-negative tumors on PET
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Blue Earth Diagnostics
Collaborator
