Prescribing Information
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The efficacy of Axumin® (fluciclovine F 18) injection was established in 2 separate clinical studies1
The FDA-approved prescribing information provides summaries from 2 clinical studies of Axumin, including an evaluation of 105 images by 3 independent readers who were unaware of the clinical details of each patient and whether the biopsy of the prostate/prostate bed or suspicious lesions on imaging were positive or negative for cancer. The charts illustrate the correctly predicted biopsy findings.
Clinical studies were based on patients with elevated prostate specific antigen (PSA) levels following radical prostatectomy and/or radiotherapy.1
Trial results
Patient PSA levels seemed to affect results with, in general, lower PSA levels correlating more frequently with negative scans than with positive scans.1
Average performance of Axumin in patients with biochemically recurrent prostate cancer1
On average, the readers correctly predicted the biopsy results for 77% of the images (range: 75%–79%). For the approximately 1/3 of the images with suspicious lesions outside the region of the prostate bed, 90% of the images were confirmed by histology.1
Charts illustrate findings from clinical trial 1 only. Information adapted from Section 14, Table 4, of Prescribing Information.
Efficacy was confirmed in a multicenter retrospective study2
Results from this multicenter retrospective study show an overall detection rate of recurrent prostate cancer of 68% (403 of 595 scans)2
Overall detection rate of ~40% in patients with PSA levels ≤0.79 ng/mL, rising to ~60% at PSA 0.80-2.032
Impact of PSA on fluciclovine F 18 PET/CT detection rate at subject and region levels in combined data set.
References
- Axumin [package insert]. Oxford, UK: Blue Earth Diagnostics Ltd; 2016.
- Bach-Gansmo T, Nanni C, Nieh PT, et al. Multisite Experience of the Safety, Detection Rate and Diagnostic Performance of Fluciclovine (18F) Positron Emission Tomography/Computerized Tomography Imaging in the Staging of Biochemically Recurrent Prostate Cancer. J Urol. 2017;197:676-683.