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

Inclusion Criteria:

* Untreated high risk biopsy-proven PCa patients according to D'Amico classification (Stage ≥ T2c or PSA level \>20ng/ml or Gleason score ≥8) (D'Amico et al 1998)
* Scheduled or planned radical prostatectomy and extended pelvic lymph node resection up to 6 weeks after the investigational PET/CT scan followed by histopathology assessment
* ECOG performance status 0-2
* Signed informed consent must be obtained prior to participation in the study
* Participants must be adults ≥ 18 years of age

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