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An Open-label, Single-arm, Rater-blinded, Multicenter Phase 1/2 Study to Assess Safety and Diagnostic Accuracy and Radiotherapeutic Implications of Pre-operative Ga-68-PSMA-11 PET/CT Imaging in Comparison to Histopathology, in Newly-diagnosed Prostate Cancer (PCA) Patients at High Risk for Metastasis, Scheduled for Radical Prostatectomy (RP) With Extended Pelvic Lymph Node Dissection (EPLND)

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Trial Profile

An Open-label, Single-arm, Rater-blinded, Multicenter Phase 1/2 Study to Assess Safety and Diagnostic Accuracy and Radiotherapeutic Implications of Pre-operative Ga-68-PSMA-11 PET/CT Imaging in Comparison to Histopathology, in Newly-diagnosed Prostate Cancer (PCA) Patients at High Risk for Metastasis, Scheduled for Radical Prostatectomy (RP) With Extended Pelvic Lymph Node Dissection (EPLND)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Gallium (68Ga) gozetotide (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Adverse reactions; Diagnostic use

    • Most Recent Events

    • 24 Jul 2020 Status changed from recruiting to completed.
    • 08 Apr 2020 This trial has been completed in Austria, as per European Clinical Trials Database record
    • 03 Apr 2020 This trial has been completed in Germany as per European Clinical Trials Database record
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