Role of [ 18 F]F-Fluciclovine PET/CT in Patients with Biochemical Recurrence of Prostate Cancer and Negative PSMA PET Results: A Single-Center Study

Our purpose was to evaluate whether [18F]F-fluciclovine PET/CT detects sites of disease in patients with biochemical recurrence (BCR) of prostate cancer and negative findings on prostate-specific membrane antigen (PSMA) PET and to assess its impact on intended management. Methods: In this prospective single-arm study (NCT05722925), 50 patients with BCR (prostate-specific antigen [PSA] ≥ 0.2 ng/mL) and negative findings on PSMA PET underwent [18F]F-fluciclovine PET/CT within 30 d of the previous imaging. Detection rate, distribution of disease, PSA-stratified analysis, management impact, and correct localization rate were assessed using descriptive statistics and exact CI. Results: [18F]F-fluciclovine PET had positive findings in 28 of 50 patients (56%; 95% CI, 41%–70%). Disease was confined to the prostate bed in 14 patients (50%), whereas 14 (50%) demonstrated nodal or distant metastases. Detection rate increased with PSA, from 44% at a PSA of 0.2–0.5 ng/mL to 100% at a PSA of 5 ng/mL or higher. The intended management changed in 71% of patients after the [18F]F-fluciclovine PET: 87% of patients with positive findings and 54% with negative findings. Among patients with an available reference standard (n = 14), all positive findings were confirmed to be true-positive. Conclusion: [18F]F-fluciclovine PET detected recurrent disease in over half of patients with negative PSMA PET findings and frequently altered management, supporting its complementary role in selected patients with BCR.