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

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ClinicalTrials.gov Identifier: NCT04838626
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:

The purpose of this study is 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) will be used for the histopathology assessments.

Approximately 195 participants will be enrolled to ensure that at least 156 participants are evaluable (i.e. have both an evaluable PET/CT scan and histopathology assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery), which will be required for the calculation of the co-primary endpoints.


Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Prostate Cancer Drug: [18F]CTT1057 Phase 2 Phase 3

Detailed Description:

This is a multi-center, single-arm, open-label prospective study to evaluate the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors, using histopathology as SoT. Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk PCa will be used for the histopathology assessments.

All participants will receive [18F]CTT1057 for PET/CT scan imaging, and surgery (radical prostatectomy and extended pelvic lymph node dissection) will be performed up to 6 weeks after but not sooner than 48 hours after the completion of the [18F]CTT1057 PET/CT scan for pathology assessment of the tissue specimens.

The co-primary endpoints of patient-level sensitivity and region-level specificity will be assessed by comparing the central reading results of the [18F]CTT1057 PET scan to the histopathology results in the dissected tissue specimens, i.e. both the primary tumor and the dissected Pelvic Lymph Node (PLN)).

Pathology will be assessed by the local pathologists as per Standard of Care (SoC), who will be blinded to the PET data.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : September 7, 2021
Estimated Primary Completion Date : February 24, 2023
Estimated Study Completion Date : February 24, 2023

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Patient-level sensitivity of [18F]CTT1057 [ Time Frame: [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan ]
    Sensitivity of [18F]CTT1057 PET imaging, considering PSMA positive patients as those who show at least one pathological [18F]CTT1057 uptake either in the primary tumor and/or metastatic PLN regions, with anatomically localized correspondence with the SoT.

  2. Region-level specificity of [18F]CTT1057 [ Time Frame: [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan ]
    Specificity of [18F]CTT1057 PET imaging, defined as proportion of PLN regions that test negative for lymph nodes on [18F]CTT1057 among those that are lymph node negative on the SoT.


Secondary Outcome Measures :
  1. Patient-level specificity of [18F]CTT1057 [ Time Frame: [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan ]
    Specificity of [18F]CTT1057 PET imaging, considering PSMA negative patients as those who do not show any pathological [18F]CTT1057 uptake either in the primary tumor or PLNs and will be confirmed not having primary tumor or metastatic PLNs with the SoT

  2. Patient-level positive predictive value of [18F]CTT1057 [ Time Frame: [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan ]
    Proportion of patients who are both [18F]CTT1057 and SoT positive (true positives (TP) among those who test positive on [18F]CTT1057 (TP+ false positives(FP)

  3. Patient-level negative predictive value of [18F]CTT1057 [ Time Frame: [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan ]
    Proportion of patients who are both [18F]CTT1057 and SoT negative (true negatives (TN)) among those who test negative on [18F]CTT1057 (TN+ false negatives (FN))

  4. Patient-level accuracy of [18F]CTT1057 [ Time Frame: [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan ]
    Proportion of patients that are SoT and [18F]CTT1057 positive (TP) and negative (TN) among all patients in EFF (TP+TN+FP+FN)

  5. Region-level sensitivity of [18F]CTT1057 for patients excluding micro-metastasis [ Time Frame: [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan ]
    Sensitivity of [18F]CTT1057 PET imaging in the PLN region, excluding from the analysis those lymph nodes showing metastasis <2mm (micro-metastasis)

  6. Region-level sensitivity of [18F]CTT1057 [ Time Frame: [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan ]
    Proportion of PLN regions that test positive on both [18F]CTT1057 and SoT (TP) among those that are SoT positive (TP+FN)

  7. Region-level positive predictive value of [18F]CTT1057 [ Time Frame: [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan ]
    Proportion of PLN regions that are SoT and [18F]CTT1057 positive (TP) among those regions that test positive on [18F]CTT1057 (TP+FP)

  8. Region-level negative predictive value of [18F]CTT1057 [ Time Frame: [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan ]
    Proportion of PLN regions that are SoT and [18F]CTT1057 negative (TN) among those regions that test negative on [18F]CTT1057 (TN+FN)

  9. Region-level accuracy of [18F]CTT1057 [ Time Frame: [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan ]
    Proportion of PLN regions that are SoT and [18F]CTT1057 positive (TP) and negative (TN) among all PLN regions assessed [18F]CTT1057 (TP+TN+FP+FN)

  10. Detection of distant metastasis in PS patients [ Time Frame: [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan ]
    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 [18F]CTT1057 PET/CT scan.

  11. Characterize the safety and tolerability of [18F]CTT1057 [ Time Frame: From first dosing (Day 1) up to 14 days post dosing ]
    The distribution of adverse events (AEs) within 14 days after the administration of [18F]CTT1057 will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

  12. [18F]CTT1057 scan inter-reader variability [ Time Frame: [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan ]
    Scan inter-reader variability is defined the agreement rate among reader determination of [18F]CTT1057 images.

  13. [18F]CTT1057 scan intra-reader variability [ Time Frame: [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan ]
    Scan intra-reader variability is defined as the within-reader agreement rate of [18F]CTT1057 images.

  14. Observed maximum blood concentration (Cmax) of [18F]CTT1057 [ Time Frame: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection) ]
    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. Cmax will be listed and summarized using descriptive statistics.

  15. Time of maximum observed blood concentration occurrence (Tmax) of [18F]CTT1057 [ Time Frame: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection) ]
    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. Tmax will be listed and summarized using descriptive statistics.

  16. Area under the [18F]CTT1057 concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) [ Time Frame: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection) ]
    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. AUClast will be listed and summarized using descriptive statistics.

  17. Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) of [18F]CTT1057 [ Time Frame: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post infusion) ]
    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. AUCinf will be listed and summarized using descriptive statistics.

  18. Terminal elimination half-life (T1/2) of [18F]CTT1057 [ Time Frame: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection) ]
    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. The half-life will be listed and summarized using descriptive statistics.

  19. Volume of distribution during the terminal phase following intravenous elimination (Vz) of [18F]CTT1057 [ Time Frame: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection) ]
    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. Vz will be listed and summarized using descriptive statistics.

  20. Total systemic clearance for intravenous administration (CL) of [18F]CTT1057 [ Time Frame: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection) ]
    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. CL will be listed and summarized using descriptive statistics.

  21. Urinary excretion of radioactivity expressed as a percentage of injected activity (%IA) of [18F]CTT1057 [ Time Frame: 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) ]
    Urine samples will be collected over specified time intervals and analyzed for radioactivity in a subset of approximately 10 patients. The radioactivity excreted in each interval as a percentage of injected activity (%IA) will be listed and summarized using descriptive statistics.

  22. Change in patient management plans attributed to the [18F]CTT1057 PET/CT scan [ Time Frame: [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan ]
    Percentage of patients who underwent a change in intended treatment plan attributed to the PET/CT scan as assessed by pre and post imaging questionnaires


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04838626


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com

Locations
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France
Novartis Investigative Site Recruiting
Nimes Cedex 9, France, 30029
Novartis Investigative Site Recruiting
Pierre Benite Cedex, France, 69495
Novartis Investigative Site Recruiting
Toulouse Cedex 9, France, 31059
Italy
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20141
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20162
Novartis Investigative Site Recruiting
Rozzano, MI, Italy, 20089
Novartis Investigative Site Recruiting
Milan, Italy
Spain
Novartis Investigative Site Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08036
Switzerland
Novartis Investigative Site Recruiting
Bellinzona, Switzerland, 6500
Novartis Investigative Site Recruiting
Geneve, Switzerland, 1205
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04838626    
Other Study ID Numbers: CAAA405A12302
2020-003958-67 ( EudraCT Number )
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
[18F]CTT1057
Positron Emission Tomography/Computerized Tomography
PET/CT
Radioligand
Imaging
Primary Staging
 PS
Standard of Truth
SoT
Prostate Cancer
PCa
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases