A phase 2 study of 99m Tc-trofolastat chloride (MIP-1404) SPECT/CT to identify and localize prostate cancer (PCa) in high-risk patients (pts) undergoing radical prostatectomy (RP) and extended pelvic lymph node (ePLN) dissection compared to histopathology: An interim analysis.

e16003 Background: Technetium Tc99m trofolastat chloride is a novel small molecule SPECT radiotracer with high affinity binding to the external domain of prostate specific membrane antigen highly expressed in PCa. We conducted an open-label, multicenter study; the primary endpoint was the ability to detect PCa within the prostate gland (PG). Secondary endpoints included detection in PLNs and comparison to MRI. Methods: Pts with PCa scheduled for RP with ePLND at high risk (≥cT3 or nomogram score ≥130) for PLN involvement were eligible. Enrolled pts required a bone scan, pelvic MRI and received trofolastat and SPECT/CT imaging 3-6 hrs later. Readers blinded to clinical information evaluated all available image data. Results were compared to histopathology assessments of RP and ePLN surgical specimens using a common anatomic template. Target to background (T:B) ratio within the PG was measured on the SPECT/CT and compared to Gleason Score (GS). Results: Enrollment has been completed and interim data is avai...