Drug updated on 10/30/2024
Dosage Form | Injection (intravenous; 335 MBq/mL to 8,200 MBq/mL [9 mCi/mL to 221 mCi/mL]) |
Drug Class | Radioactive 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.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Axumin (fluciclovine F 18) Prescribing Information. | 2022 | Blue Earth Diagnostics, Inc., Burlington, MA |