Diagnostic Performance of [18F]PSMA-1007 in the Context of Biochemical Recurrence of Prostate Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorHeinrich-Heine University, Duesseldorf

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
From the timepoint of recruitment on for a time frame of 6 months for each individual
2

Clinical Impact

The assesment of the anticipated rate of therapy change based on the PSMA-PET imaging for the patients with BCR

Time frame
From the timepoint of recruitment on for a time frame of 6 months for each individual

Secondary outcomes

1

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

Time frame
From the timepoint of recruitment on for a time frame of 24 months for each individual

Other outcomes

Sponsors and contacts

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