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

Phase II/III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging for the Detection of PSMA Positive Tumors Using Histopathology as a Standard of Truth

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms; Prostate Cancer
• Intervention / Treatment: Drug: [18F]CTT1057

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).

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13273
    • Novartis Investigative Site
  • Nîmes, France, 30029
    • Novartis Investigative Site
  • Pierre-Bénite, France, 69495
    • Novartis Investigative Site
  • Toulouse, France, 31059
    • Novartis Investigative Site
  • Toulouse, France, 31054
    • Novartis Investigative Site
• Italy
  • BG
    • Bergamo, BG, Italy, 24127
      • Novartis Investigative Site
  • MI
    • Milan, MI, Italy, 20162
      • Novartis Investigative Site
    • Milan, MI, Italy, 20141
      • Novartis Investigative Site
    • Milan, MI, Italy, 20132
      • Novartis Investigative Site
    • Rozzano, MI, Italy, 20089
      • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 08036
    • Novartis Investigative Site
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Novartis Investigative Site
  • Catalonia
    • Barcelona, Catalonia, Spain, 08035
      • Novartis Investigative Site
• Switzerland
  • Bellinzona, Switzerland, 6500
    • Novartis Investigative Site
  • Geneva, Switzerland, 1211
    • Novartis Investigative Site
• United States
  • California
    • Sacramento, California, United States, 95816
      • Explorer Molecular Imaging center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: [18F]CTT1057; PET/CT imaging with [18F]CTT1057; Other Names: Single intravenous dose of approximately 370 Mega-Becquerel (MBq) and subsequent PET/CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-level Specificity of Vidoflufolastat (18F) - % Specificity	Specificity of vidoflufolastat (18F) PET imaging, considering PSMA negative patients as those who do not show any pathological vidoflufolastat (18F) uptake either in the primary tumor or PLNs and will be confirmed not having primary tumor or metastatic PLNs with 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
Patient-level Positive Predictive Value of Vidoflufolastat (18F)	Proportion of patients who are both vidoflufolastat (18F) and SoT positive (true positives (TP) among those who test positive on vidoflufolastat (18F) (TP+ false positives (FP))	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)	Proportion of patients who are both vidoflufolastat (18F) and SoT negative (true negatives (TN)) among those who test negative on vidoflufolastat (18F) (TN+ false negatives (FN))	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)	Proportion of patients that are SoT and vidoflufolastat (18F) positive (TP) and negative (TN) among all patients in Efficacy Analysis Set (EFF) (TP+TN+FP+FN)	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	Proportion of PLN regions that test positive on both vidoflufolastat (18F) and SoT (TP) among those that are SoT positive (TP+FN)	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 Positive Predictive Value of Vidoflufolastat (18F)	Proportion of Pelvic Lymph Node (PLN) regions that are Standard of Truth (SoT) and vidoflufolastat (18F) positive (TP) among those regions that test positive on vidoflufolastat (18F) (TP+False Positive (FP))	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 Negative Predictive Value of Vidoflufolastat (18F)	Proportion of PLN regions that are SoT and vidoflufolastat (18F) negative (TN) among those regions that test negative on vidoflufolastat (18F) (TN+FN)	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 Accuracy of Vidoflufolastat (18F)	Proportion of PLN regions that are SoT and vidoflufolastat (18F) positive (TP) and negative (TN) among all PLN regions assessed vidoflufolastat (18F)(TP+TN+FP+FN)	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) Scan With Standard of Truth Excluding Pelvic Lymph Node (PLN) Metastasis < 2 mm	Sensitivity of vidoflufolastat (18F) PET imaging in the PLN region, excluding from the analysis those lymph nodes showing metastasis <2mm (micro-metastasis)	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
Detection of Distant Metastasis of Vidoflufolastat (18F) Scan - Participants With at Least One Distant Metastatic Lesion (%)	Number of distant metastasis identified at PET/CT scan in all patients, and percentage of patients with at least one distant metastatic lesion (extra-PLN, visceral or skeletal)identified by PET scan in all patients with an evaluable vidoflufolastat (18F) PET/CT scan.	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
Overview of Adverse Events	An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject	Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
Vidoflufolastat (18F) Scan Inter-reader Variability - %	Scan inter-reader variability is defined the agreement rate among reader determination of vidoflufolastat (18F) images.	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
Vidoflufolastat (18F) Scan Inter-reader Variability - Number of Scans Agreed	Scan inter-reader variability is defined the agreement rate among reader determination of vidoflufolastat (18F) images.	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
Vidoflufolastat (18F) Scan Intra-reader Variability	Scan intra-reader variability is defined as the within-reader agreement rate of vidoflufolastat (18F) images.	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
Observed Maximum Blood Concentration (Cmax) of Vidoflufolastat (18F)		Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
Time of Maximum Observed Blood Concentration Occurrence (Tmax) of Vidoflufolastat (18F)		Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
Area Under the Vidoflufolastat (18F) Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)		Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) of Vidoflufolastat (18F)		Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post infusion)
Half-Life Lambda z of Vidoflufolastat (18F)		Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) of Vidoflufolastat (18F)		Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
Urinary Excretion of Radioactivity Expressed as a Percentage of Injected Activity (%IA) of Vidoflufolastat (18F)		Day 1 (pre-injection/0 hour, 0 hour (injection) - T (image acquisition starting time), T (image acquisition starting time) to 3 hours, 3 hours to 5 hours post imaging)
Total Systemic Clearance for Intravenous Administration (CL) of Vidoflufolastat (18F)		Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• A Plain Language Trial Summary is available on www.novctrd.com

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Actual): November 24, 2023
• Study Completion (Actual): November 24, 2023

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Imaging; PET/CT; Prostate Cancer; [18F]CTT1057; Positron Emission Tomography/Computerized Tomography; Radioligand; Primary Staging; PS; Standard of Truth; SoT; PCa
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CAAA405A12302; 2020-003958-67 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No