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
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.
In a recent study, Axumin demonstrated a high detection rate of prostate cancer recurrence3*
This was a retrospective cohort study of 152 men who had suspected biochemical recurrence of prostate cancer after receiving initial treatment and had an Axumin scan. Detection rates (DR) were calculated for whole-body, prostate and prostate bed, and extraprostatic locations. The influence of different factors (absolute PSA level, PSA kinetics, the Gleason score, and Gleason grade groups) on the DR were evaluated.
Initial therapy received by patients (N=152)
Note: Data are number of patients.
Abbreviations: BT, brachytherapy; EBRT, external beam radiation therapy; HT, hormone therapy; RP, radical prostatectomy.
Axumin demonstrated an overall (whole-body) detection rate of 81%
Of the 152 patients in the cohort:
- 92 (61%) had positive findings within the prostate and prostate bed
- 83 (55%) had positive findings in the extraprostatic region (lymph nodes, bone, viscera, or a combination of these locations)
Axumin detection rates were consistent across patients with or without hormone therapy
*Information on the presence or absence of disease was not available for most patients, therefore, the diagnostic performance of fluciclovine F 18 PET/CT could not be evaluated.
Axumin detection rates correlated with increasing PSA levels3
The Axumin detection rate increased linearly with an increasing PSA level (P<.001).
Detection rate of extraprostatic disease (including pelvic and extrapelvic lymph nodes, bone, lung, and liver lesions) was 55%.
PSA doubling time or velocity had no statistically significant effect on the detection rates of Axumin
Likelihood of detecting extraprostatic lesions with positive Axumin findings significantly increased with an increasing Gleason score
Safety data were not reported
- 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.
- Savir-Baruch B, Lovec P, Solanki AA, et al. Fluorine-18-labeled fluciclovine PET/CT in clinical practice: factors affecting the rate of detection of recurrent prostate cancer. AJR Am J Roentgenol. 2019;213(4):851-858.