Fluciclovine F-18
Fluciclovine F-18 was the first PET tracer approved for finding recurrent prostate cancer after treatment (2016), and has been largely superseded since 2020 by PSMA PET.
Approved May 2016 for suspected recurrence with rising PSA; detection ~68% overall, lower at low PSA. EMSPOT/EMPIRE-1 (Lancet 2021) showed fluciclovine-guided salvage radiotherapy improved failure-free survival. PSMA PET (Ga-68 PSMA-11, piflufolastat, flotufolastat) has higher detection and displaced it.
- Medicare
- Part B (clinician-administered)
Diagnostic radiopharmaceutical billed with the PET/CT scan under Part B for suspected prostate cancer recurrence; PSMA agents have largely displaced it.
- Commercial insurance
- variable
Covered by many plans for biochemical recurrence, but some now require PSMA PET as the preferred tracer.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · Medicare.gov: Diagnostic non-laboratory tests (imaging). Not medical or financial advice; verify with your plan.
- Notes
- EU-licensed but not commissioned for routine NHS use; PSMA PET is preferred.
- NHS England
- Not routinely funded
Sources: NICE search: fluciclovine F-18. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2016 | PET imaging in men with suspected prostate cancer recurrence based on elevated PSA |
| EU | 2017 | Same |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
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