Multisite Experience of the Safety, Detection Rate and Diagnostic Performance of Fluciclovine ( ¹⁸ F) Positron Emission Tomography/Computerized Tomography Imaging in the Staging of Biochemically Recurrent Prostate Cancer

Abstract

Purpose Sensitive detection of cancer foci in men experiencing biochemical recurrence following initial treatment of prostate cancer is of great clinical significance with a possible impact on subsequent treatment choice. We describe a multisite experience of the efficacy and safety of the positron emission tomography/computerized tomography agent fluciclovine (18F) after biochemical recurrence. Materials and Methods A total of 596 patients underwent fluciclovine (18F) positron emission tomography/computerized tomography at 4 clinical sites. Detection rate determinations were stratified by the baseline prostate specific antigen value. Diagnostic performance was assessed against a histological reference standard in 143 scans. Results The subject level fluciclovine (18F) positron emission tomography/computer tomography detection rate was 67.7% (403 of 595 scans). Positive findings were detected in the prostate/bed and pelvic lymph node regions in 38.7% (232 of 599) and 32.6% of scans (194 of 596), respectively. Metastatic involvement outside the pelvis was detected in 26.2% of scans (155 of 591). The subject level detection rate in patients in the lowest quartile for baseline prostate specific antigen (0.79 ng/ml or less) was 41.4% (53 of 128). 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. The positive predictive value of fluciclovine (18F) positron emission tomography/computerized tomography scanning for all sampled lesions was 62.2%, and it was 92.3% and 71.8% for extraprostatic and prostate/bed involvement, respectively. Fluciclovine (18F) was well tolerated and the safety profile was not altered following repeat administration. Conclusions Fluciclovine (18F) is well tolerated and able to detect local and distant prostate cancer recurrence across a wide range of prostate specific antigen values.

Management of Patients with Advanced Prostate Cancer: The Report of the Advanced Prostate Cancer Consensus Conference APCCC 2017

“…Regarding the PET/CT tracers comparative studies between prostate-specific membrane antigen (PSMA) and choline have demonstrated superiority of PSMA to identify bone lesions [98]. The PET tracer 18 Ffluciclovine has recently been approved for use in North America; available data indicate good detection rates both for lymph nodes and for bone disease in biochemical recurrence of prostate cancer [99]. The diagnostic performance of fluciclovine PET was found to be superior to CT and to choline PET but there are no comparative data versus WB-MRI and PSMA PET [100].…”

Comparison of 68Ga-PSMA-11 and 18F-Fluciclovine PET/CT in a Case Series of 10 Patients with Prostate Cancer Recurrence

“…Several molecular imaging approaches have been proposed over the last decade. The best results for assessing patients with PCa recurrence were obtained with 18 F-fluciclovine and PSMA-targeted PET radiotracers (2)(3)(4)(5).…”

State‐of‐the‐art imaging techniques in the management of preoperative staging and re‐staging of prostate cancer

“…However, the DR in the lowest serum PSA quartile (≤0.79 ng/mL) was as low as 41.4% . In a prospective comparison with 11 C‐choline in 89 patients, 18 F‐fluciclovine resulted in being slightly superior in terms of sensitivity and superior in terms of specificity. In particular, the 11 C‐choline and 18 F‐FACBC, sensitivities were 32% and 37%, the specificities 40% and 67%, the accuracies 32% and 38%, the PPVs 90% and 97%, and the NPVs 3% and 4%, respectively …”