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.
Study Type
OBSERVATIONAL
Enrollment
174
PSMA PET/CT using the intervention.
Inselspital, Universitätsspital Bern
Bern, Switzerland
Primary objective: To confirm the PPV of the new tracer (patient-based PPV)
The primary end point is the per patient PPV for the detection of PSMA-positive tumour lesions as confirmed by either a) histology or b) a composite reference standard of imaging and/or PSA fall following focal therapy in the absence of systemic therapy.
Time frame: At one year follow up
• To determine the patient-based detection rate of pathologic scans (sensitivity) for the new tracer
Patient based detection (PET-positivity) rate (stratified by PSA value)
Time frame: Within one week of scan
To explore the regional based PPV
Region-based PPV (prostate bed, pelvic lymph nodes, extra-pelvic lymph nodes, extra-pelvic viscera and bone metastases)
Time frame: At one year follow up
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