were detectable with a high correct localization rate (CLR) and a positive predictive value (PPV) when the investigational prostate-specific membrane antigen (PSMA) PET imaging agent 18F-DCFPyL, according to data from the pivotal phase 3 CONDOR study.
These results were reported at the 2021 Genitourinary Cancers Symposium as the FDA prepares to make a decision on a new drug application (NDA) for the prostate-specific membrane antigen (PSMA) PET imaging agent.1
The multicenter phase 3 CONDOR study (NCT03739684) enrolled men with rising prostate-specific antigen (PSA) after definitive therapy and negative or equivocal standard-of-care imaging. Patients were required to have a PSA level of 0.2 or higher if they had undergone radical prostatectomy (RP) or a PSA level of 2.0 or higher if they were treated with radiation therapy or cryotherapy.
The radiolabeled small molecule 18F-DCFPyL…