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

NCT04838626 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CAAA405A123022020-003958-67
• Study Type: interventional
• Target: 195
• Locations: 5 countries
• Sites: 16

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 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.

Conditions

Prostatic Neoplasms; Prostate Cancer

Keywords

[18F]CTT1057; Positron Emission Tomography/Computerized Tomography; PET/CT; Radioligand; Imaging; Primary Staging; PS; Standard of Truth; SoT; Prostate Cancer; PCa

Outcome Measures

Primary Outcomes (2)

• Patient-level Sensitivity of Vidoflufolastat (18F) - % Sensitivity

  Sensitivity of vidoflufolastat (18F) Positron Emission Tomography (PET) imaging, considering Prostate Specific Membrane Antigen (PSMA) positive patients as those who show at least one pathological vidoflufolastat (18F) uptake either in the primary tumor and/or metastatic Pelvic Lymph Node (PLN) regions, with anatomically localized correspondence with the Standard of Truth (SoT).

  vidoflufolastat (18F)7 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

• Region-level Specificity of Vidoflufolastat (18F) - % Specificity

  Specificity of vidoflufolastat (18F) PET imaging, defined as proportion of PLN regions that test negative for lymph nodes on vidoflufolastat (18F) among those that are lymph node negative on the SoT.

  vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

Secondary Outcomes (22)

• Patient-level Specificity of Vidoflufolastat (18F) - % Specificity

  vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

• Patient-level Positive Predictive Value of Vidoflufolastat (18F)

  vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

• Patient-level Negative Predictive Value of Vidoflufolastat (18F)

  vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

• Patient-level Accuracy of Vidoflufolastat (18F)

  vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

• Region-level Sensitivity of Vidoflufolastat (18F) - % Sensitivity

  vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan

Study Arms (1)

PET/CT imaging with [18F]CTT1057

EXPERIMENTAL

All eligible participants will be enrolled to receive \[18F\]CTT1057 imaging agent on Day 1 and have PET/CT scan

Drug: [18F]CTT1057

Interventions

[18F]CTT1057 DRUG

PET/CT imaging with \[18F\]CTT1057

Also known as: Single intravenous dose of approximately 370 Mega-Becquerel (MBq) and subsequent PET/CT scan

PET/CT imaging with [18F]CTT1057

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (16)

Explorer Molecular Imaging center

Sacramento, California, 95816, United States

Location

Novartis Investigative Site

Marseille, 13273, France

Location

Novartis Investigative Site

Nîmes, 30029, France

Location

Novartis Investigative Site

Pierre-Bénite, 69495, France

Location

Novartis Investigative Site

Toulouse, 31054, France

Location

Novartis Investigative Site

Toulouse, 31059, France

Location

Novartis Investigative Site

Bergamo, BG, 24127, Italy

Location

Novartis Investigative Site

Milan, MI, 20132, Italy

Location

Novartis Investigative Site

Milan, MI, 20141, Italy

Location

Novartis Investigative Site

Milan, MI, 20162, Italy

Location

Novartis Investigative Site

Rozzano, MI, 20089, Italy

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, 08036, Spain

Location

Novartis Investigative Site

Bellinzona, 6500, Switzerland

Location

Novartis Investigative Site

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will receive \[18F\]CTT1057 for PET/CT scan imaging, and surgery will be performed up to 6 weeks after \[18F\]CTT1057 PET for pathology assessment of the tissue specimens. Additional pharmacokinetics (PK) assessments will be performed on the date of imaging in a subset of approximately 10 patients at the same site.

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 9, 2021
• Study Start: September 7, 2021
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: October 7, 2025
• Results First Posted: December 18, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

IT (5); FR (5); CH (2); ES (3); US (1)