The Utility of PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men with High GC Decipher® Test Scores: A Sub-aim of the VANDAAM Study (MCC #18523)
This study deals with a new imaging test known as 18F-DCFPyLPSMA PET, or 18F-DCFPyL-PSMA positron emission tomography. The objective of this study is to evaluate usefulness of using 18F-DCFPyL in detecting recurrent/metastatic prostate cancer. The 18F-DCFPyL PET imaging technique is used in some parts of the world but is not currently standard imaging care.
The primary objective of this study is to estimate the concordance between tumor GC risk score and early metastatic disease using PSMA-PET imaging.
PSMA- PET imaging will begin 2 years post-treatment for patients with high GC scores, and then every year up to 5 years. We will use a high GC score (defined as GC >0.45) as a surrogate for early risk of early metastatic disease within 5 years. Biopsies of suspicious lesions will not be performed routinely unless deemed appropriate by treating physician and/or confirmed on conventional imaging.
To validate the GC as a predictor of 5-year metastatic disease using PSMA-PET imaging.
To compare 5-yr rate of early metastatic disease in a matched cohort of AAM vs NAAM with high GC scores.
To identify biomarkers that can predict aggressive PCa and early metastasis.
This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score >0.45).
Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia
Administration of any radioisotope within 5 physical half-lives OR any IV X-ray contrast medium within 24 hours OR any high-density oral contrast medium (oral water contrast acceptable) within 5 days prior to study drug injection
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