Multisite Experience of the Safety, Detection Rate and Diagnostic Performance of Fluciclovine (18F) 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.

Keywords: emission-computed; fluciclovine F-18; local; neoplasm recurrence; positron-emission tomography; prostatic neoplasms; tomography.

Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1

A, in 68-year-old male after radical prostatectomy with PSA rising to 0.4 ng/ml fluciclovine (18F) transverse PET/CT recurrence (arrow) in left prostate bed. B, in 67-year-old male after radical prostatectomy with sipuleucel-T and bicalutamide, rising to 0.91 ng/ml and negative bone scan sagittal fluciclovine (18F) PET/CT detected 3 to 4 mm presacral node (arrow). C, 64-year-old male after radical prostatectomy with PSA rising rapidly to 3.7 ng/ml 2 weeks before scanning transverse fluciclovine (18F) PET/CT (bone window) detected solitary bone metastasis (arrow) in right proximal femur.

Figure 2

Impact of PSA on fluciclovine (18F) PET/CT detection rate at subject and region levels in combined data set.

Figure 3

In 61-year-old male with PSA rising to 0.4 ng/ml after robot-assisted laparoscopic prostatectomy fluciclovine transverse PET/CT detected 8 mm mesorectal lymph node metastasis (arrow).