An Investigational Imaging Scan ([18F]DCFPyL PET/CT) in Monitoring Response to Treatment in Patients with Metastatic Castrate Resistant Prostate Cancer

PRIMARY OBJECTIVE:

I. To determine whether changes in uptake of fluorine F 18 DCFPyL ([18F]DCFPyL) PET/CT scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rPFS) as defined by Prostate Cancer Working Group 3 (PCWG3) criteria.

SECONDARY OBJECTIVES:

I. To determine whether changes in uptake of [18F]DCFPyL PET/CT scans correlate with overall survival (OS).

II. To determine whether baseline maximum standardized uptake value (SUVmax) correlate with rPFS.

III. To compare number of lesions detected with standard imaging at baseline and at the time of progression.

EXPLORATORY OBJECTIVES:

I. To determine whether circulating tumor deoxyribonucleic acid (DNA) (ctDNA) and/or exosome signatures at baseline will predict response to treatment.

II. To determine whether changes in ctDNA and or exosomes at the time of disease progression reveal resistance mechanisms to current therapies.

III. To determine whether changes in uptake on [18F]DCFPyL PET/CT scans at baseline and after 6 weeks of treatment correlate with circulating tumor DNA (ctDNA) and/or serum exosome signatures.

OUTLINE:

Patients receive fluorine F 18 DCFPyL intravenously (IV) and then undergo PET/CT scan at baseline, after 6 weeks of the new therapy, and on progression of disease. Depending on preliminary fluorine F 18 DCFPyL PET/CT scan results, up to 5 patients may undergo an optional fluorine F 18 DCFPyL PET/CT scan after 2 weeks of starting the new therapy.