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Clinical Trial 19291

Cancer Type: Genitourinary
Study Type: Diagnostic
NCT#: NCT03495427

Phase: Phase II/III
Principal Investigator: Yamoah, Kosj

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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)


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.


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.




Inclusion Criteria

  • 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
  • Previously enrolled to MCC#18523
  • Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen
  • Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (>0.45)
  • Treated with radical prostatectomy (RP) or radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT)) with ≥2 years follow up
  • Age > 18

  • Exclusion Criteria

  • No follow up information available post treatment
  • 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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