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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
In a retrospective, observational study evaluating the efficacy and safety of Axumin PET imaging in patients with suspected biochemically recurrent prostate cancer.1
*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)
In a multicenter, retrospective, observational study of the efficacy and safety of Axumin PET/CT in 596 patients with biochemical recurrence2
68% (403 of 595 scans) overall detection rate of recurrent prostate cancer2
The positive predictive value (PPV) of Axumin in the prostate bed was 72% for prostate/bed involvement.2
American Journal of Roentgenology (Savir-Baruch)
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
Note: Data are number of patients.
Abbreviations: BT, brachytherapy; EBRT, external beam radiation therapy; HT, hormone therapy; RP, radical prostatectomy.
Of the 152 patients in the cohort:
PSA doubling time or velocity has no statistically significant effect on the detection rates of Axumin3
Likelihood of detecting extraprostatic lesions with positive Axumin findings significantly increased with an increasing Gleason score3
Safety data were not reported in this study
Axumin® (fluciclovine F 18) injection is 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.
Please see Axumin full Prescribing Information.