Radiopharmaceutical developer Blue Earth Diagnostics is highlighting results from a phase III clinical trial of its Axumin (fluciclovine F-18) PET radiopharmaceutical agent indicating a 68% detection rate for prostate cancer recurrence.
Axumin is a molecular imaging agent indicated for use in PET imaging in men with suspected prostate cancer recurrence based on elevated blood levels of prostate-specific antigen (PSA) following prior treatment. Results of the multicenter study demonstrated a 68% overall detection rate for Axumin, with the ability to detect local and distant prostate cancer recurrence across a range of PSA values, the firm said.
The study assessed the diagnostic performance and safety of Axumin in men with biochemical recurrence of prostate cancer. A total of 596 patients underwent Axumin PET/CT imaging at four clinical sites in Norway, Italy, and the U.S. to determine the detection rate stratified by PSA values.
Axumin was assessed against histopathology in 143 scans and was found to have a detection rate of 68%. In the prostate/bed and pelvic lymph node regions, positive findings were detected in 39% and 33% of scans, respectively. Metastatic involvement outside the pelvis was detected in 26% of Axumin scans. The detection rate for Axumin in patients in the lowest quartile of baseline PSA (< 0.79 ng/mL) was 41%. Of these patients, 13 had involvement in the prostate/bed only, 16 had pelvic lymph node involvement without distant disease, and 24 had distant metastases.
For the 143 patient scans, the positive predictive value (PPV) of Axumin PET/CT scanning was 82%. For tumors in the prostate/prostate bed, the PPV was 72% and for extraprostatic tumors it was 92%. Adverse events were reported in 5.4% of patients, with none considered related to Axumin. The safety profile was not altered following repeat administration. The authors concluded that Axumin is well-tolerated and able to detect local and distant prostate cancer recurrence across a wide range of PSA values, Blue Earth Diagnostics said.
The study was published online in the Journal of Urology on October 13.
