Real-World data show utility of 18F-fluciclovine PET/CT in biochemically recurrent prostate cancer

January 25, 2021
Jason M. Broderick

,
Lisette Hilton

Twelve percent of patients with negative results on conventional imaging had lesion localization on 18F-fluciclovine PET.

Use of 18F-fluciclovine (Axumin) PET/CT changed clinical management in 62% of patients with biochemically recurrent prostate cancer, according to real-world data from an academic center published in Molecular Imaging and Biology.1

Twelve percent of patients with negative results on conventional imaging had lesion localization on 18F-fluciclovine PET.

18F-Fluciclovine PET/CT remains a useful diagnostic tool in the workup of patients with BCR PC,” authors concluded.

The study retrospectively assessed 18F-fluciclovine scans of 165 consecutive men with biochemical recurrence after receiving primary definitive treatment. Among these patients, 102 had undergone prostatectomy as their primary treatment and 63 had received radiotherapy.

18F-fluciclovine PET had an overall positivity rate of 67%. There was an expected incremental increase in the positivity rate as patients’ PSA levels increased, from a low of 15% among patients with a PSA <0.5 ng/ml, to a high of 94% among patients with a PSA ≥5 ng/ml. Overall, the results of 18F-fluciclovine PET resulted in a change in clinical management in 162 patients.

Additional findings were assessed in 33 patients who received 1 or more other PET imaging, including 18F-NaF PET/CT (12 patients), 68Ga-PSMA11 PET/CT (5 patients), 18F-DCFPyL PET/CT (20 patients), and 68Ga-RM2 PET/MRI (5 patients). Among 14 of these patients, changes to the patient’s treatment plan were made based on further PET imaging with a different radiopharmaceutical.

Prior clinical trial of 18F-fluciclovine PET/CT

Previous results from a study published in the Journal of Urology showed that 18F-fluciclovine PET/CT detects metastases better than conventional imaging in patients with high-risk prostate cancer.2

In this clinical trial, 57 patients with high-risk prostate cancer were staged by conventional imaging, including 99mTc-methylene diphosphonate bone scanning and CT or MRI. They then underwent 18F-fluciclovine PET/CT, followed by robotic radical prostatectomy and extended pelvic lymph node dissection.

18F-fluciclovine PET/CT detected nodal metastasis with a sensitivity of 55.3% and a specificity of 84.8% in each patient. PET imaging sensitivity and specificity were 54.8% and 96.4%, respectively, per region (right and left pelvis, presacral and nonregional), according to the paper.

The advanced imaging had 22% greater sensitivity for each patient compared with conventional imaging. And 18F-fluciclovine PET/CT detected regional and nonregional metastases in patients with prostate cancer that went undetected with conventional imaging. PET/CT detected metastases in 7 more patients and 22 more regions and identified distant disease or other cancers in 4 patients.

In the paper, the authors noted that their findings were in line with results of other studies published in the literature.

The FDA approved the radiopharmaceutical 18F-fluciclovine in May 2016 for PET imaging in men with suspected prostate cancer recurrence based on elevated PSA levels following prior treatment.

References

1. The Clinical Utility of 18F-Fluciclovine PET/CT in Biochemically Recurrent Prostate Cancer: an Academic Center Experience Post FDA Approval [published online ahead of print January 19, 2021]. Mol Imaging Biol. doi: 10.1007/s11307-021-01583-3

2. Alemozaffar M, Akintayo AA, Abiodun-Ojo OA, et al. [18F]Fluciclovine positron emission tomography/computerized tomography for preoperative staging in patients with intermediate to high risk primary prostate cancer. J Urol. 2020;204(4):734-740. doi:10.1097/JU.0000000000001095