Status:
COMPLETED
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Prostatic Neoplasms
Prostate Cancer
Eligibility:
MALE
18-100 years
Phase:
PHASE2
PHASE3
Brief Summary
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...
Detailed Description
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2023
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT04838626
Start Date
September 7 2021
End Date
November 24 2023
Last Update
October 7 2025
Active Locations (16)
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1
Explorer Molecular Imaging center
Sacramento, California, United States, 95816
2
Novartis Investigative Site
Marseille, France, 13273
3
Novartis Investigative Site
Nîmes, France, 30029
4
Novartis Investigative Site
Pierre-Bénite, France, 69495