Table 1.
Prospective trials evaluating the management change rate after restaging PET/CT in prostate cancer patients with biochemical recurrence after radical prostatectomy.
Trial | N | Study design | Primary endpoint | Results |
---|---|---|---|---|
Andriole et al. (27) LOCATE - NCT02680041 |
114 | Prospective trial: 18F-Fluciclovine |
Management change post scan | - Management change: 48% (32% omission SRT; 16% change in SRT volumes) |
Scarsbrook et al. (30) FALCON - NCT02578940 |
104 (63% RP) |
Prospective trial: 18F-Fluciclovine |
Management change post scan | - Management change: 64% - PSA response rate: 72% without PET/CT guidance vs 88% with PET/CT guidance |
Morris et al. (32) CONDOR - NCT03739684 |
208 | Prospective trial: 18F-DCFPyL (PyL) PSMA |
Correct localization rate (CLR) vs composite standard of truth | - CLR: 84.8% to 87.0% (positive trial) - Management change: 63.9% |
NCT02940262 | 1200, active not recruiting | Prospective trial: 68Ga-PSMA |
Sensitivity of 68Ga-PSMA for detection of tumor location | - Management change: 53% (ancillary study of 161 recurrent patients) (34) |
PSMA, prostate specific membrane antigen; SOC, standard of care; SRT, salvage radiotherapy; RP, radical prostatectomy.