Primary endpoint
RECURRENCES, METASTASES, BONE METASTASES
A total of 205 patients with first BCR underwent [The per-patient DR, based on the number of observed cases receiving both tracers (N = 201), was significantly higher for [Per-patient detection rate according to the PSA concentration level at first injection for patients after radical prostatectomy ± eLND (observed case) – full analysis set (N = 205)Observed case: missing or indeterminate results are not imputed Explanatory note: Full analysis set comprised 205 patients that had been imaged with only one tracer. Observed case refers to 201 patients that were scanned with both tracers. One-hundred-fifty out of 201 patients had radical prostatectomy ± eLND. From these, 15 patients had no PSA at baseline and 3 patients had only one tracer, resulting in a total number of 132 patientsPer-patient detection rate according to the PSA concentration level at first injection for patients after radiation therapy (observed case) – full analysis set (N = 205)Observed case: missing or indeterminate results are not imputed Explanatory note: Full analysis set comprised 205 patients that had been imaged with only 1 tracer. Observed case refers to 201 patients that were scanned with both tracers. Fifty-five out of 201 patients had radiation therapy. From these, 5 patients had no PSA at baseline and 1 patient had only one tracer, resulting in a total number of 49 patientsIn the subanalysis, local recurrences (21% vs. 11%), bone metastases (17% vs. 9%) and metastases in other organs (9.0% vs. 2.0%) were more often detected by [Detection rate for pelvic (When considering the initial treatment with curative intent, the DR was: 47% (69/147) 