About this trial
Following numerous retrospective studies and Phase-3-Studies with promising results, \[18F\]PSMA-1007 has been approved by european authorities. Therefore, it is a growing deployment of this diagnostic method anticipated. This study aims to investigate the diagnostic performance and clinical impact in a real-world-evidence in the context of regular clinical care. The evidence generated by this approach is supposed to assist in optimizing the management of prostate cancer patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed Consent
Conduct of [18F]PSMA-1007 PET Imaging in the context of regular clinical care
Disqualifiers
Technical Flaws in the acquisition protocol
Trial population
The patient cohort will consist of biologically male patients with a histopathologically proven prostate cancer following a curative-intent cancer therapy. These patients will be referred to our center due to suspected recurrence.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
PSA-Stratified Detection rate of [18F]PSMA-1007 in BCR
Assessment of detection rate of molecular imaging in accordance with composite reference method or histopathological validation, if available
Clinical Impact
The assesment of the anticipated rate of therapy change based on the PSMA-PET imaging for the patients with BCR
Secondary outcomes
Prognostic value of [18F]PSMA-1007 for the patients with BCR
Assessment of prognostic value of \[18F\]PSMA-1007 imaging in terms of recurrence-free Survival and overall survival
Sponsors and contacts
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