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

NCT ID: NCT04838626

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-07
• Study Completion Date: 2023-11-24

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.

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 and localization of prostate specific membrane antigen (PSMA) positive tumors, using histopathology as standard of truth (SoT). in newly diagnosed high-risk prostate cancer (PCa) patients.

A total of 195 participants were enrolled to ensure that at least 156 participants were evaluable for the co-primary endpoints. Surgery was performed after vidoflufolastat (18F) positron emission tomography/computerized tomography (PET/CT) scan.

The co-primary endpoints of patient-level sensitivity and region-level specificity were assessed by comparing the central reading results of the vidoflufolastat (18F) PET/CT scan to the local histopathology results in the dissected tissue specimens, i.e. both the primary tumor and the dissected Pelvic Lymph Nodes (PLNs).

Conditions

Prostatic Neoplasms; Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PET/CT imaging with [18F]CTT1057

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

Group Type: EXPERIMENTAL

[18F]CTT1057

Intervention Type: DRUG

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

Interventions

[18F]CTT1057

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

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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

Countries

United States; France; Italy; Spain; Switzerland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-003958-67

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAAA405A12302

Identifier Type: -

Identifier Source: org_study_id