On May 27, 2016, the FDA approved a new PET Scan tracer (injection) for prostate cancer patients with “suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment.” Two studies helped the Axumin PET Scan obtain its FDA approval. In one study, results from the Axumin PET Scans were compared with biopsy pathology, and read by several radiologists independent of each other.(1)
The second study compared the Axumin PET Scan to the C11 Choline PET Scan, which is currently available at the Mayo Clinic. (3) Patients in this study had a median PSA of 1.44. (Median is the middle number, not the average number.) Again, several radiologists read the scans independently and reported their findings. Based on these 2 studies, the FDA ruled that the Axumin PET Scan was both safe and effective.
Oni, et. al. [(14)C]Fluciclovine (alias anti-[(14)C]FACBC) uptake and ASCT2 expression in castration-resistant prostate cancer cells. Nucl Med Biol. 2015 Nov;42(11):887-92
Nanni et. al. 18F-Fluciclovine PET/CT for the Detection of Prostate Cancer Relapse; A Comparison to 11C-Choline PET/CT. Clin Nucl Med 2015 Aug;40(8):e386-91