INTRODUCTION AND OBJECTIVE:
Several PSMA-targeted imaging agents are currently in development for initial staging of men at risk of harboring metastatic prostate cancer (PCa) not detected by conventional imaging (CI). 18F-DCFPyL is a novel PSMA-targeted radiopharmaceutical that has the potential to improve treatment planning for PCa patients both at the time of initial staging and in the event of disease recurrence. Here we report on the utility of 18F-DCFPyL-PET/CT at initial assessment and its impact on intended management in men with high risk PCa.
18F-DCFPyL-PET/CT was evaluated in men with NCCN high-risk PCa scheduled to undergo radical prostatectomy with pelvic lymphadenectomy (RP-PLND). A single dose of 9 mCi (333 MBq) of 18F-DCFPyL was administered via intravenous injection, followed by PET/CT acquisition 1 to 2 hours thereafter. Three, blinded, independent central readers evaluated the 18F-DCFPyL scans. Imaging results were compared to surgical pathology as the truth standard. Changes to clinical management plans were evaluated based on review of individual patient-level baseline clinical and CI data by an independent central panel of experts using Medical Management Questionnaires completed before and after 18F-DCFPyL-PET/CT.
268 men (median PSA 9.7 [range 1.2-125.3], n=267) underwent 18F-DCFPyL-PET/CT. Staging by CI, compared to disease assessment by 18F-DCFPyL-PET/CT, is presented in Table 1. After 18F-DCFPyL-PET/CT, 72 (26.9%) patients were considered staged as N1M0=39 (14.6%); N1M1=12 (4.5%); N0M1=21 (7.8%). In addition, incorporation of 18F-DCFPyL-PET/CT results led to a change in planned management by an assessment panel independent of the trial procedures for 43.6% (115/264) of patients; in 39.0% (103/264), a change in surgery or type of surgery was recommended and, in 25.8% (68/264), a change in planned radiation therapy was recommended.
18F-DCFPyL-PET/CT identified probable occult N1 and M1 disease in 19% and 12.3% of high-risk patients scheduled to undergo RP-PLND, respectively. These data suggest that 18F-DCFPyL-PET/CT may have a substantial impact on the staging and subsequent management of patients with high-risk PCa. Clinicaltrials.gov: NCT02981368.
Source of Funding:
Progenics Pharmaceuticals, Inc