Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
Completed · Phase 2/Phase 3
Conditions studied: Prostatic Neoplasms, Prostate Cancer
In brief
The purpose of this study was 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) were used for the histopathology assessments.
Key facts
- Study ID
- NCT04838626
- Run by
- Novartis Pharmaceuticals
- People needed
- 195
- Starts
- 2021-09-07
- Expected to finish
- 2023-11-24
- Last updated by the study team
- 2025-10-07
Who can join
Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Explorer Molecular Imaging center — Sacramento, California, United States
- Novartis Investigative Site — Marseille, France
- Novartis Investigative Site — Nîmes, France
- Novartis Investigative Site — Pierre-Bénite, France
- Novartis Investigative Site — Toulouse, France
- Novartis Investigative Site — Toulouse, France
- Novartis Investigative Site — Bergamo, BG, Italy
- Novartis Investigative Site — Milan, MI, Italy
- Novartis Investigative Site — Milan, MI, Italy
- Novartis Investigative Site — Milan, MI, Italy
- Novartis Investigative Site — Rozzano, MI, Italy
- Novartis Investigative Site — L'Hospitalet de Llobregat, Barcelona, Spain
- Novartis Investigative Site — Barcelona, Catalonia, Spain
- Novartis Investigative Site — Barcelona, Spain
- Novartis Investigative Site — Bellinzona, Switzerland
- Novartis Investigative Site — Geneva, Switzerland
Full record on ClinicalTrials.gov
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