A Phase 3, Open-label Study to Assess the Clinical Utility of Fluciclovine (18F) PET/CT in Patients With Prostate Cancer With Biochemical Recurrence After Radical Treatment

Trial Profile

A Phase 3, Open-label Study to Assess the Clinical Utility of Fluciclovine (18F) PET/CT in Patients With Prostate Cancer With Biochemical Recurrence After Radical Treatment

Discontinued
Phase of Trial: Phase III

Latest Information Update: 10 Feb 2018

At a glance

  • Drugs Fluciclovine 18F (Primary)
  • Indications Prostate cancer
  • Focus Diagnostic use; Registrational
  • Acronyms FALCON
  • Sponsors Blue Earth Diagnostics
  • Most Recent Events

    • 10 Feb 2018 Status changed from suspended to discontinued as the pre-specified condition defining overwhelming efficacy was met, according to results of a pre-planned interim analysis presented at the 2018 Genitourinary Cancers Symposium.
    • 10 Feb 2018 Primary endpoint (Percentage of men who have their management plan changed after a fluciclovine (18F) PET/CT scan: pre-planned interim analysis) has been met, according to results presented at the 2018 Genitourinary Cancers Symposium.
    • 10 Feb 2018 Results of a pre-planned interim analysis (n=85), presented at the 2018 Genitourinary Cancers Symposium.
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