Abstract
163 Background: Fluciclovine (18F) is an FDA-approved positron emission tomography/computerized tomography (PET/CT) tracer in clinical use for the detection and localization of biochemically recurrent (BCR) prostate cancer. Here, we report the impact of clinical factors and study site on its performance. Methods: In total, 596 subjects with BCR prostate cancer underwent fluciclovine (18F) PET/CT scanning at four sites in Italy, Norway and USA. Detection Rates (DR), including region level analyses, were stratified by prostate specific antigen (PSA) levels, PSA doubling time (PSAdt), Gleason score (GS), and by investigator/site. Extra-prostatic disease was defined as all positivity outside of residual prostate, prostate bed and seminal vesicles. Results: Fluciclovine (18F) PET/CT was positive in 67.7% (403/595) of subjects. Positive findings were detected in the prostate/bed and pelvic lymph node regions in 38.7% (232/599) and 32.6% (194/596) of scans, respectively. Metastatic involvement outside the pelvis was found in 26.2% (155/591) of scans. Generally, DR increased with increasing baseline PSA (Table 1). While subject level DR did not vary significantly with PSAdt (DR = 60-69% across all categories), a positive extra-prostatic scan was more likely in patients with shorter PSAdt (DR = 52%, 48%, 37% and 28% for PSAdt <3, 3-<6, 6-<12 and >12 months, respectively). Among 361 subjects for whom baseline GS was available, scores ≥9 were associated with the highest extra-prostatic DR (55%) compared with 23% in patients with GS ≤6. Inter-site variations in acquisition protocols may have impacted DR at low baseline PSA values; with subject level DR at PSA >0.2-0.5 ng/ml = 20%, 38%, 46% and 73% at site A, B, C and D, respectively. Conclusions: Fluciclovine (18F) can detect and localize BCR prostate cancer in a wide range of subjects and, with appropriate imaging protocols, has a clinically useful DR at PSA <0.5 ng/ml. Clinical trial information: NCT02443571. [Table: see text]
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