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A PrOspective Phase 2/3 Multi-Center Study of 18F-DCFPyL PET/CT Imaging in Patients With PRostate Cancer: Examination of Diagnostic AccuracY (OSPREY)

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A PrOspective Phase 2/3 Multi-Center Study of 18F-DCFPyL PET/CT Imaging in Patients With PRostate Cancer: Examination of Diagnostic AccuracY (OSPREY)

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 28 Feb 2024

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At a glance

  • Drugs Piflufolastat F18 (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Diagnostic use; Registrational
  • Acronyms OSPREY
  • Sponsors Progenics Pharmaceuticals

    • Most Recent Events

    • 22 Feb 2024 According to a Curium Pharma media release, based on results from the Phase III PYTHON, OSPREY and CONDOR trial, the imaging AG on 31 January 2024 has submitted marketing authorization application for PYLCLARI (INN: Piflufolastat (18F) formerly known as (18F)-DCFPyL) to the Swiss Agency for Therapeutic Products (Swissmedic) which has been accepted for evaluation.
    • 01 May 2023 According to a Curium Pharma media release, based on data from the Phase III PYTHON, OSPREY and CONDOR trial, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended to grant a marketing authorization for PYLCLARI (piflufolastat (18F)) indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer.
    • 18 Feb 2023 Results of secondary analysis (n=208) assessing Changes in planned disease management after piflufolastat F18 PET/CT in men with biochemically recurrent prostate cancer and low PSA levels presented at the 2023 Genitourinary Cancers Symposium

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