TheranosticTrials.org

Clinical Trial · NCT03495427

PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores

Overview

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). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Phase

Phase 2/3

Contacts

Riley Smith (CONTACT)

riley.smith@moffitt.org

813-799-6821

Kosj Yamoah, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03495427

Drug / Compound

DCFPyL

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • * 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).
  • 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)
  • Previously enrolled to MCC#18523
  • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1

Exclusion

  • 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
  • Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia
  • * No follow up information available post treatment