Spots Global Cancer Trial Database for Diagnostic Accuracy and Performance of 18F-PSMA-1007

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Trial Identification

Brief Title: Diagnostic Accuracy and Performance of 18F-PSMA-1007

Official Title: Diagnostic Accuracy and Performance of 18F-PSMA-1007 in the Detection of Recurrent Prostate Cancer - a Prospective, Single-arm Study

Study ID: NCT04986280

Conditions

Prostate Cancer

Interventions

[18F]PSMA-1007

Study Description

Brief Summary: Whereas 18F-PSMA-1007 has rapidly established itself as a radiotracer for the investigation of prostate cancer, there are no studies confirming its diagnostic performance. The purpose of this study is to determine the diagnostic performance for this radiotracer.

Detailed Description: In this prospective, single-armed diagnostic imaging study men undergoing standard-of-care PSMA PET/CT using \[18F\]PSMA-1007 shall be studied. The primary objective is to confirm the positive predictive value (PPV) of this tracer at a patient-based level by recruiting until 53 patients with follow-up to a composite reference standard are available. Secondary outcomes shall include patient based rate of pathological-scans stratified by PSA, the PPV stratified by region , interrelate agreement, frequency of indeterminate lesions and the safety and tolerability of the examination.