Clinical Trial 19291

Study Title

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)

Summary

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.

Objective

Primary Objective: 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. Secondary Objectives: 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.