Diagnostic Accuracy and Performance of 18F-PSMA-1007

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

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.

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.

Inclusion Criteria:

• Adult Patients referred for investigation of recurrent PC by PSMA PET/CT.
• Patients with known biochemical recurrence of a histologically confirmed primary prostate cancer, defined as:

Post prostatectomy: two consecutive PSA > 0.2 ng/ml Post-radiotherapy: a rise of 2ng/mL > post-therapy nadir (ASTRO consensus definition)

• Male patients >18 years old
• PSA measured ± 4 weeks of the PSMA-PET/CT
• Patients willing and able to consent to the informed consent document

Exclusion Criteria:

• Patients with ADT within 6 months prior to the PSMA-PET/CT
• Inability to provide informed, written consent
• Patients undergoing active treatment for a second non-prostatic malignancy