Primary Objective: * To determine whether changes in uptake of \[18F\]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: * To determine whether changes in uptake of \[18F\]DCFPyL PET/CT scans correlate with overall survival (OS) * To determine whether baseline SUVmax correlate with rPFS * To compare number of lesions detected with standard imaging at baseline and at the time of progression
Prostate cancer is the most common cancer and the third most common cause of cancer deaths in American men. The lethal form of the disease is metastatic castrate resistant prostate cancer (mCRPC). Serum prostate specific antigen (PSA) testing has been relied upon heavily as a marker of disease and is commonly used in the community to guide therapy. PyL, also known as \[18F\]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
\[18F\]DCFPyL will be used for study imaging. It will be administered intravenously on the day of imaging. Subjects will receive a bolus injection of 9mCi (331 MBq) of \[18F\]DCFPyL through a peripheral IV catheter. 60 to 120 minutes after injection, a whole body (toes to vertex) lowdose CT will be obtained (120 kVp, 80 mA maximum).
As per standard of care, acquisition will be performed on PET/CT scanner (Siemens, Germany) operating in 3D emission mode with CT-derived attenuation correction.
Columbia University Irving Medical Center
New York, New York, United States
Prevalence of changes in PyL PET imaging correlating with radiographic Progression-Free Survival (rPFS)
To determine if changes in PyL PET/CT scans before and after 6 weeks on treatment is associated with stability of disease as measured by standard imaging.
Time frame: Baseline, Post-treatment (approximately 6 weeks)
Prevalence of changes in uptake of [18F]DCFPyL PET/CT scans correlating with Overall Survival (OS)
The percent difference in summed SUV between the first and second PET/CT will be noted.
Time frame: Baseline, Post-treatment (approximately 6 weeks)
Prevalence of baseline SUVmax correlating with rPFS
To determine if standardized uptake values (SUVs) at baseline is a good measure for patient evaluation.
Time frame: Baseline, Post-treatment (approximately 6 weeks)
Change in number of lesions detected with standard imaging at baseline and at the time of progression
To compare lesions detected with standard imaging
Time frame: Baseline, up to 1 year
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