The efficacy of Axumin® (fluciclovine F 18) injection was established in 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. Patient PSA levels seemed to affect results with, in general, lower PSA levels correlating more frequently with negative scans than with positive scans.1
Pivotal Trial
High levels of accuracy seen with Axumin
A retrospective, observational study evaluating the efficacy and safety of Axumin PET imaging in patients with suspected biochemically recurrent prostate cancer.1
Confidence across all regions1*
*105 images were evaluated by 3 independent readers who were unaware of the clinical details of each patient and whether the biopsy of the prostate bed or suspicious lesions on imaging were positive or negative for cancer. N is averaged across the 3 readers.
aAccuracy average of 3 blinded readers.
bAccuracy range across 3 blinded readers.
Accuracy= true positive + true negative/true positive + false positive + true negative + false negative.
Journal of Urology (Bach-Gansmo)
High detection rate even with low PSA levels
A multicenter, retrospective, observational study of the efficacy and safety of Axumin PET/CT in 596 patients with biochemical recurrence2
Distribution of recurrent and metastatic sites in men with positive Axumin scans (N=403)2:
68% (403 of 595 scans) overall detection rate of recurrent prostate cancer2
High detection rate across PSA levels
Impact of PSA on Axumin PET/CT detection rate at subject and region levels in combined data set2
Detection rates of ~40% in patients with PSA levels ≤0.79 ng/mL, rising to ~60% at PSA 0.80-2.03 ng/mL2
American Journal of Roentgenology (Savir-Baruch)
High detection rate of recurrence correlated with increasing PSA levels
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.3
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%3
Of the 152 patients in the cohort:
- 61% (92) had positive findings within the prostate and prostate bed
- 55% (83) had positive findings in the extraprostatic region (lymph nodes, bone, viscera, or a combination of these locations)
Detection rates correlated with increasing PSA levels3
A linear increase followed rising PSA levels (P<0.001)3
PSA doubling time or velocity has no statistically significant effect on the detection rates of Axumin3
Similar detection rates seen regardless of hormone therapy status3
Detection rates with and without hormone therapy3
Likelihood of detecting extraprostatic lesions with positive Axumin findings significantly increased with an increasing Gleason score3
Safety data were not reported in this study
References:
- Axumin [package insert]. Oxford, UK: Blue Earth Diagnostics Ltd; May 2021.
- 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.