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Clinical trial

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)

NCT03362359 is registered in ClinicalTrials.gov with German Cancer Research Center as lead sponsor.

NCT NCT03362359
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Registry record

As filed in ClinicalTrials.gov.

Title
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)
Lead sponsor
German Cancer Research Center
Phase
Phase 1/2
Overall status
Completed
Start date
October 9, 2017
Completion date
July 6, 2020
Enrollment
173 (actual)
Sites
8

Conditions

As the registry lists them; a condition with its own page is linked.

high-risk prostate cancer, lymphnode metastasis, prostate cancer, prostate cancer metastatic