Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection

Exclusion Criteria

• •Inability to complete the needed investigational and standard-of-care imaging examinations due to any reason (severe claustrophobia, inability to lie still for the entire imaging time, etc.)
• •Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation, including, but not limited to, current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, need of indwelling/condom catheters, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, and COVID-19.
• •Known allergy, hypersensitivity, or intolerance to \[18F\]CTT1057
• •Prior and current use of PSMA targeted therapies
• •Prior and current treatment with any ADT (first or second generation), including LHRH analogues (agonists or antagonists)
• •Any 5-alpha reductase inhibitors within 30 days before screening
• •Patients with small cell or neuroendocrine PCa in more than 50% of biopsy tissue
• •Patients with incidental PCa after transurethral resection
• •Use of other investigational drugs within 30 days before screening