Drug updated on 9/4/2024
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.
Latest News
Summary
- Axumin (fluciclovine F18) 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.
- This summary is based on the review of 12 systematic review(s)/meta-analysis(es). [1-12]
- Pooled detection rates (DRs) for biochemical prostate cancer recurrence showed PSMA radiotracers had higher detection rates across PSA levels: <0.5 ng/mL (44%), 0.5-0.99 ng/mL (60%), 1.0-1.99 ng/mL (80%), compared to choline and fluciclovine.
- In the initial staging of high-risk prostate cancer, fluciclovine and PSMA showed similar diagnostic performance with sensitivity of 85% and 84% (P = .78), and specificity of 77% and 83% (P = .40), respectively.
- For primary staging of prostate cancer, the pooled sensitivity was 83% (95% CI: 80-86), and specificity was 77% (95% CI: 74-80); for preoperative LN staging, sensitivity was 57% (95% CI: 39-73) and specificity was 99% (95% CI: 94-100).
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
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 |