18F-fluciclovine PET-CT and 68Ga-PSMA-11 PET-CT in patients with early biochemical recurrence after prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial.

摘要: Summary Background National Comprehensive Cancer Network guidelines consider 18F-fluciclovine PET-CT for prostate cancer biochemical recurrence localisation after radical prostatectomy, whereas European Association of Urology recommend prostate-specific membrane antigen (PSMA) PET-CT. To the best our knowledge, no prospective head-to-head comparison between these tests has been done so far. The aim this study was to compare prospectively paired and PSMA scans localising prostatectomy in patients with low (PSA) concentrations ( Methods This a prospective, single-centre, open-label, single-arm comparative at University California Los Angeles (Los Angeles, CA, USA). Patients older than 18 years age PSA levels ranging from 0·2 2·0 ng/mL without any prior salvage therapy Karnofsky performance status least 50 were eligible. underwent (reference test) (index within 15 days. Detection rate patient level by anatomical region primary endpoint. A statistical power analysis demonstrated that sample size needed show 22% difference detection rates favour (test superiority). Each PET scan interpreted three independent masked readers consensus majority interpretation generated (two vs one) determine positive findings. is registered ClinicalTrials.gov, number NCT02940262, complete. Findings Between Feb 26, 2018, Sept 20, 143 screened eligibility, whom enrolled into study. Median follow-up 8 months (IQR 7–9). endpoint met; significantly lower (13 [26%; 95% CI 15–40] 50) (28 [56%; 41–70] 50), an odds ratio (OR) 4·8 (95% 1·6–19·2; p=0·0026) level; subanalysis pelvic nodes (four [8%; 2–19] [30%; 18–45] PET-CT; OR 12·0 [1·8–513·0], p=0·0034); extrapelvic lesions (none [0%; 0–6] eight [16%; 7–29]; non-estimable [95% non-estimable], p=0·0078). Interpretation With higher rates, should be tracer choice when imaging considered subsequent treatment management decisions (≤2·0 ng/mL). Further research investigate whether translate improved oncological outcomes. Funding None.