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

• Status: Recruiting
• Trial end date: 2023-02-24
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as Standard of Truth (SoT). Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk prostate cancer (PCa) will be used for the histopathology assessments.

Approximately 195 participants will be enrolled to ensure that at least 156 participants complete the [18F]CTT1057 PET/CT scan procedure (i.e. investigational imaging agent administration and successful completion of the PET/CT scan), which will be required for the calculation of the co-primary endpoints.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Signed informed consent must be obtained prior to participation in the study

• Untreated high risk biopsy-proven PCa patients according to D'Amico classification (Stage T2c or Prostate Specific Antigen (PSA) level >20ng/ml or Gleason score ≥8)

• 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

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• 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 reasons (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 Coronavirus Disease 2019 (COVID-19)

• Known allergy, hypersensitivity, or intolerance to [18F]CTT1057

• Prior and current use of PSMA targeted therapies

• Prior and current treatment with Luteinizing Hormone-Releasing Hormone (LHRH) analogues

• Any prior Androgen Deprivation Therapy (ADT) (first or second generation) within 9 months before screening

• 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