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

This was a multi-center, single-arm, open-label prospective study to evaluate the diagnostic performance of vidoflufolastat (18F) as a positron emission tomography (PET) imaging agent for detection and localization of prostate specific membrane antigen (PSMA) positive tumors, using histopathology as standard of truth (SoT). in newly diagnosed high-risk prostate cancer (PCa) patients.

A total of 195 participants were enrolled to ensure that at least 156 participants were evaluable for the co-primary endpoints. Surgery was performed after vidoflufolastat (18F) positron emission tomography/computerized tomography (PET/CT) scan.

The co-primary endpoints of patient-level sensitivity and region-level specificity were assessed by comparing the central reading results of the vidoflufolastat (18F) PET/CT scan to the local histopathology results in the dissected tissue specimens, i.e. both the primary tumor and the dissected Pelvic Lymph Nodes (PLNs).

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