TABLE 1

Definitions of Criteria

CriterionDefinition
NL (new lesions)Appearance of at least 1 new PSMA-positive lesion on iPET, which was defined as any new focal uptake of PSMA ligand higher than surrounding background, and each tumor SUVmax > mean SUVmean
RECIP
 RECIP-CRAbsence of any PSMA uptake on iPET
 RECIP-PRPSMA-VOL_PR without appearance of new lesions
 RECIP-PDPSMA-VOL_PD with appearance of new lesions
 RECIP-SDInsufficient decline in PSMA-VOL to qualify for PSMA-VOL_PR or PSMA-VOL_PR with appearance of new lesions or insufficient increase in PSMA-VOL to qualify for PSMA-VOL_PD or PSMA-VOL_PD without appearance of new lesions
Response classifications
 PSAResponse: ≥50% decrease; progression: ≥25% increase
 RECIPResponse: RECIP-PR; progression: RECIP-PD
 PSA + RECIPResponse: PSA ≥ 50% decrease or RECIP-PR/RECIP-CR; progression: PSA ≥ 25% increase or RECIP-PD