A Pilot Study for Detection of PSMA-Low Castration Resistant and Neuroendocrine Prostate Cancer With 18F-fluciclovine PET/CT Imaging
Brigham and Women's Hospital
Summary
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
Description
This research study is a pilot study, which is the first-time investigators are examining this study imaging agent, 18F-fluciclovine, for use in PSMA-low castration resistant and neuroendocrine prostate cancer detection. 18F-fluciclovine is approved by the U.S. Food and Drug Administration (FDA). It is approved for imaging the early stages of prostate cancer. It is not approved for imaging PSMA-low castration resistant or neuroendocrine prostate cancer. 18F-fluciclovine is a radiotracer for PET imaging that targets amino-acid receptors. Some information shows that both PSMA-low and neuroendoc…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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 pl…
Interventions
- Drug18F-fluciclovine
18F-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
- DevicePET/CT
Positron 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.
Locations (2)
- Dana Farber Cancer InstituteBoston, Massachusetts
- Brigham and Womens HospitalBoston, Massachusetts