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A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Clinical Impact of 18F-DCFPyL PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer

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Trial Profile

A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Clinical Impact of 18F-DCFPyL PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2019

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At a glance

  • Drugs 18F DCFPyL (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Diagnostic use; Registrational
  • Acronyms CONDOR
  • Sponsors Progenics Pharmaceuticals

    • Most Recent Events

    • 07 Nov 2019 According to a Progenics Pharmaceuticals media release, NDA submission is expected in July 2020.
    • 05 Aug 2019 According to a Progenics Pharmaceuticals media release, the last patient visit is expected in September and top-line data is expected by year end.
    • 05 Aug 2019 According to a Progenics Pharmaceuticals media release, the company recently met with the U.S. FDA to discuss the regulatory path for PyL. Based on those discussions, the company believes that positive data from this study and the previously reported OSPREY study could serve as the basis for a regulatory submission. Progenics intends to submit a New Drug Application (NDA) with the FDA for PyL following this phase 3 CONDOR study, assuming positive results.
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