Drug updated on 4/26/2024
| Dosage Form | Injection (intravenous; 9-221 mCi/mL) |
| Drug Class | Radioactive 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
- 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 Title | Year | Source |
|---|---|---|
| Axumin (fluciclovine F18) Prescribing Information. | 2022 | Blue Earth Diagnostics Ltd., Oxford, UK |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| PSMA PET/CT: joint EANM procedure guideline/SNMMI procedure standard for prostate cancer imaging 2.0. | 2022 | European Journal of Nuclear Medicine and Molecular Imaging |
| [18F]fluciclovine PET/CT: joint EANM and SNMMI procedure guideline for prostate cancer imaging—version 1.0. | 2019 | European Journal of Nuclear Medicine and Molecular Imaging |
| UK guidelines on 18F-fluciclovine PET/CT in prostate cancer imaging. | 2019 | Nuclear Medicine Communications |