TheranosticTrials.org

Clinical Trial · NCT04838613

Study of Diagnostic Performance of [18F]CTT1057 in BCR

Overview

The current study aimed at evaluating the diagnostic performance of \[18F\]CTT1057 as a PET imaging agent for detection and localization of Prostate specific membrane antigen (PSMA) positivity in patients diagnosed of biochemical recurrence of prostate cancer (PCa), using a composite truth standard. Approximately 190 participants were to be enrolled to ensure at least 152 participants were evaluable (i.e. have both an evaluable \[18F\]CTT1057 Positron emission tomography/Computed Tomography (PET/CT) scan imaging and at least one evaluable Composite Truth Standard (CTS) assessment and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures, which were required for the calculation of the co-primary endpoints.

Sponsor

Novartis

Phase

Phase 3

Contacts

Novartis Pharmaceuticals (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT04838613

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

CTT1057

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

Inclusion criteria not yet provided.

Exclusion

  • Known allergy, hypersensitivity, or intolerance to \[18F\]CTT1057, \[68Ga\]Ga-PSMA-11, or to CT contrast
  • Use of other investigational drugs within 30 days before screening
  • Patient with small cell or neuroendocrine PCa in more than 50% of biopsy tissue
  • Castration-resistant patients
  • Any 5-alpha reductase inhibitors within 30 days before screening
  • Prior major surgery undergone less than 12 weeks prior to screening (with the exception of any surgery related to prostatic cancer)
  • Prior and current use of PSMA targeted therapies
  • Prior salvage surgery or salvage radiation therapy
  • Prior ADT (first or second generation), including LHRH analogues (agonists or antagonists), within 9 months before screening
  • 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