Fluciclovine F 18

(Axumin®)

Axumin®

Drug updated on 10/30/2024

Dosage FormInjection (intravenous; 335 MBq/mL to 8,200 MBq/mL [9 mCi/mL to 221 mCi/mL])
Drug ClassRadioactive diagnostic agents
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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.

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Summary
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  • This summary is based on the review of 12 systematic review(s)/meta-analysis(es). [1-12]
  • Detection Rates for Biochemical Recurrence (BCR) by PSA (Prostate-Specific Antigen) Levels: Fluciclovine detection rates varied by PSA level, with 37% at PSA < 0.5 ng/mL, 44% at 0.5-0.99 ng/mL, and 61% at 1.0-1.99 ng/mL, while PSMA (prostate-specific membrane antigen) showed higher detection rates of 44%, 60%, and 80% for these PSA levels, respectively. In another study, PSMA demonstrated rates of 58%, 75%, 86%, and 94% for PSA levels < 0.5, 0.5-0.99, 1.0-1.99, and > 2.0 ng/mL, respectively.
  • Primary Tumor Detection Accuracy: Fluciclovine and PSMA radiotracers had similar diagnostic accuracy for primary tumor detection in initial staging of high-risk prostate cancer, with sensitivity and specificity of 85% and 77% for fluciclovine and 84% and 83% for PSMA, respectively.
  • Impact on Management and Outcomes: Fluciclovine PET (Positron Emission Tomography)/CT resulted in management changes in 59-63% of patients and was associated with improved failure-free survival when used in radiotherapy planning.
  • Pooled Sensitivity and Specificity in Recurrence Detection: Fluciclovine showed a pooled sensitivity and specificity of 0.68 for detecting recurrence in relapsed prostate cancer patients.
  • 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 TitleYearSource
Axumin (fluciclovine F 18) Prescribing Information.2022Blue Earth Diagnostics, Inc., Burlington, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparing the diagnostic performance of radiotracers in prostate cancer biochemical recurrence: a systematic review and meta-analysis2022European Radiology
(18)F-Fluciclovine versus PSMA PET Imaging in Primary Tumor Detection during Initial Staging of High-Risk Prostate Cancer: A Systematic Review and Meta-Analysis2022Imaging Cancer
The Diagnostic Role of (18)F-Choline, (18)F-Fluciclovine and (18)F-PSMA PET/CT in the Detection of Prostate Cancer With Biochemical Recurrence: A Meta-Analysis2021Frontiers in Oncology
(18)F-Fluciclovine PET/CT performance in biochemical recurrence of prostate cancer: a systematic review2021Prostate Cancer and Prostatic Diseases
18F-Fluciclovine Positron Emission Tomography in Prostate Cancer: A Systematic Review and Diagnostic Meta-Analysis2021Diagnostics
(18)F-Fluciclovine PET for Assessment of Prostate Cancer with Histopathology as Reference Standard: A Systematic Review2021PET Clinics
Comparing the diagnostic performance of radiotracers in recurrent prostate cancer: a systematic review and network meta-analysis2021European Journal of Nuclear Medicine and Molecular Imaging
PSMA-targeted Radiotracers versus (18)F Fluciclovine for the Detection of Prostate Cancer Biochemical Recurrence after Definitive Therapy: A Systematic Review and Meta-Analysis2020Radiology
Current Imaging Techniques for and Imaging Spectrum of Prostate Cancer Recurrence and Metastasis: A Pictorial Review2020Radiographics
Imaging for Metastasis in Prostate Cancer: A Review of the Literature2020Frontiers in Oncology
Diagnostic Performance of PET/CT Using 18F-FACBC in Prostate Cancer: A Meta-Analysis2019Frontiers in Oncology
The role of (18)F-fluciclovine PET in the management of prostate cancer: a systematic review and meta-analysis2019Clinical Radiology

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