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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

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

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

Progenics Pharmaceuticals, Inc.

Collaborator