Fluciclovine F18

(Axumin®)

Fluciclovine F18

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Drug updated on 4/26/2024

Dosage FormInjection (intravenous; 9-221 mCi/mL)
Drug ClassRadioactive diagnostic agents
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

Summary
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  • Fluciclovine F18 (Axumin) is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
  • A total of 12 studies were reviewed, all related to the performance and diagnostic accuracy of Fluciclovine F18 in the context of prostate cancer detection, both in primary staging and recurrent settings.
  • In terms of detection rates for biochemical prostate cancer recurrence, Fluciclovine generally exhibited higher rates compared to choline across different PSA levels. However, PSMA-based radiotracers demonstrated superior detection rates especially at lower PSA levels.
  • For initial staging of high-risk prostate cancer, there was no statistically significant difference between Fluciclovine and PSMA PET's diagnostic test accuracy. Both modalities had comparable sensitivity and specificity indicating that they can be equally effective in diagnosing and staging this disease.
  • The sensitivity and specificity demonstrated by Fluciclovine varied depending on whether it was used for primary or recurrent diagnosis as well as the target area being diagnosed. Generally though, its performance was similar or slightly less than that achieved by PSMA-based tracers particularly when detecting biochemical recurrences.
  • The effectiveness of both Fluciclovine PET/CT scans versus those using a PSMA tracer are influenced by PSA levels; however, at lower PSA values where early detection is crucially important - the latter outperforms Axumin significantly more often than not according to these studies' findings.
  • Studies showed that the use of Axumin significantly impacted decisions due to its ability to guide therapy choices effectively, which aligns with literature about other advanced PET imaging techniques like those involving a targeted approach toward Prostate-Specific Membrane Antigen (PSMA).
  • The pooled analyses suggest that despite the lack of detailed subgroup considerations such as hormone sensitivity or previous treatments received, Fluciclovine PET is beneficial across a broad range of prostate cancer scenarios including patients who have undergone radical prostatectomy or those with biochemically recurrent disease.

Product Monograph / Prescribing Information

Document TitleYearSource
Axumin (fluciclovine F18) Prescribing Information.2022Blue Earth Diagnostics Ltd., Oxford, UK

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparing the diagnostic performance of radiotracers in prostate cancer biochemical recurrence: A systematic review and meta-analysis.2022European Radiology
18F-Fluciclovine versus PSMA PET imaging in primary tumor detection during initial staging of high-risk prostate cancer: a systematic review and meta-analysis.2022Radiology Imaging Cancer
18F-fluciclovine positron emission tomography in prostate cancer: a systematic review and diagnostic meta-analysis.2021Diagnostics
The diagnostic role of 18F-choline, 18F-fluciclovine and 18F-PSMA PET/CT in the detection of prostate cancer with biochemical recurrence: a meta-analysis.2021Frontiers in Oncology
18F-fluciclovine PET for assessment of prostate cancer with histopathology as reference standard: A systematic review.2021PET Clinics
Positron emission tomography and whole-body magnetic resonance imaging for metastasis-directed therapy in hormone-sensitive oligometastatic prostate cancer after primary radical treatment: A systematic review.2021European Urology Oncology
18F-fluciclovine PET/CT performance in biochemical recurrence of prostate cancer: a systematic review.2021Prostate Cancer and Prostatic Diseases
Comparing the diagnostic performance of radiotracers in recurrent prostate cancer: a systematic review and network meta-analysis. 2021European Journal of Nuclear Medicine and Molecular Imaging
PSMA-targeted radiotracers versus 18F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: A systematic review and meta-analysis.2020Radiology
Diagnostic performance of PET/CT using 18F-FACBC in prostate cancer: A meta-analysis.2020Frontiers in Oncology
18F-Facbc in prostate cancer: a systematic review and meta-analysis.2019Cancers
The role of 18F-fluciclovine PET in the management of prostate cancer: a systematic review and meta-analysis.2019Clinical Radiology

Clinical Practice Guidelines