About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- F-DCFPyL Injection
- PSMA PET
Treatment groups
Sponsors and collaborators
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Progenics Pharmaceuticals, Inc.
Collaborator