Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer

Exclusion Criteria11

• Patients for whom radical prostatectomy is not clinically appropriate or the patient is otherwise unlikely to undergo radical prostatectomy with extensive pelvic lymph node dissection.
• The patient has received any therapy - be it radiation, surgical or drug therapy - for his prostate cancer.
• The patient has any contraindication(s) for and/or known hypersensitivity to any constituent(s) of \[18F\]PSMA-1007.
• The patient is not able to have PET-CT scans (for example, because of weight, claustrophobia, or inability to lie still for the duration of the scan).
• The patient is closely affiliated to the investigation site; e.g. is a first-degree relative of the investigator.
• At the time of screening, the patient is receiving any other investigational agent(s), or he has received any such agent(s) within the previous 30 days, or he is scheduled to receive any such agent(s) in the period up to the planned date for the last study visit.
• The patient has previously been enrolled in this trial.
• The patient has previously undergone PET imaging with any PSMA-avid product.
• The patient has histological evidence of small-cell carcinoma of the prostate.
• The patient is clinically unstable or requires emergency treatment.
• The patient has any mental condition rendering him incapable of understanding the nature, scope, and consequences of the trial as set out in the information given to the patient.