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ACTIVE NOT RECRUITING
NCT03824275
PHASE2/PHASE3

18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer

Sponsor: Columbia University

View on ClinicalTrials.gov

Summary

PyL, also known as \[18F\]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted PET imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. Its ability to image metastatic prostate cancer sites was comparable to 68Ga-PSMA with high tumor-to-background ratios.Additionally, \[18F\] PyL demonstrated higher mean tumor-to-background ratios when using kidney, spleen, or parotid as reference organs. However, the role of \[18F\] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

129

Start Date

2019-02-12

Completion Date

2023-12

Last Updated

2022-05-11

Healthy Volunteers

No

Interventions

DRUG

18F- DCFPyL PET/CT

A CT scan using a radioactive marker to better image tumors

Locations (1)

Columbia University Irving Medical Center

New York, New York, United States