Next-Generation Imaging

The FDA is currently reviewing the results of these trials and is scheduled to make an approval decision by May 28, 2021.

The FDA is scheduled to make a decision on a new drug application for 18F-DCFPyL on or before May 28, 2021.

The novel PSMA-targeted radiopharmaceutical for PET identified M1 disease in the majority of patients examined who otherwise had locoregional disease, according to a subanalysis of the OSPREY trial.

Twelve percent of patients with negative results on conventional imaging had lesion localization on 18F-fluciclovine PET.

Dr. Declan G. Murphy discusses results from the phase 3 proPSMA study of Ga 68 PSMA-11 in patients with high-risk prostate cancer.

The agency approved the first PSMA-targeted PET imaging drug for men with prostate cancer.

EMPIRE-1 is the first randomized trial to demonstrate an improvement in failure-free survival with treatment based on advanced molecular imaging versus conventional imaging in men with recurrent prostate cancer.

The imaging modality detected nodal metastasis with a sensitivity of 55.3% and a specificity of 84.8% in each patient.