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    Clinical Trial Results:
    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 (GuideView)

    Summary
    EudraCT number
    		 2020-003958-67
    Trial protocol
    		 FR   ES   IT  
    Global end of trial date
    24 Nov 2023

    Results information
    Results version number
    		 v1
    This version publication date
    09 Nov 2024
    First version publication date
    09 Nov 2024
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    CAAA405A12302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04838626
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Nov 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives were: • Evaluate the patient-level sensitivity of vidoflufolastat (18F) • Evaluate the region-level specificity of vidoflufolastat (18F) Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com for complete trial results.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Sep 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 45
    Country: Number of subjects enrolled
    Italy: 54
    Country: Number of subjects enrolled
    Spain: 80
    Country: Number of subjects enrolled
    Switzerland: 12
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    195
    EEA total number of subjects
    179
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    92
    From 65 to 84 years
    103
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 195 patients were enrolled. 184 participants received vidoflufolastat (18F) and 184 underwent PET/CT. 173 patients completed the study and 184 patients completed treatment.

    Pre-assignment
    Screening details
    		 A total of 195 participants were enrolled. 184 participants completed the study treatment phase (PET imaging completed)

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 PET/CT imaging with vidoflufolastat (18F).
    Arm description
    		 Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan
    Arm type
    		 Experimental

    Investigational medicinal product name
    vidoflufolastat (18F)
    Investigational medicinal product code
    AAA405
    Other name
    [18F]CTT1057
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan

    Number of subjects in period 1
    		PET/CT imaging with vidoflufolastat (18F).
    Started
    195
    Completed
    173
    Not completed
    22
         Consent withdrawn by subject
    9
         Physician decision
    6
         Adverse event, non-fatal
    2
         Technical Problems
    2
         Protocol deviation
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PET/CT imaging with vidoflufolastat (18F).
    Reporting group description
    		 Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan

    Reporting group values
    		 PET/CT imaging with vidoflufolastat (18F). Total
    Number of subjects
    		 195 195
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 92 92
        From 65-84 years
    		 103 103
        85 years and over
    		 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 64.5 ( 6.41 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 0 0
        Male
    		 195 195
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 0 0
        White
    		 192 192
        More than one race
    		 0 0
        Unknown or Not Reported
    		 2 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 56 56
        Not Hispanic or Latino
    		 122 122
        Unknown or Not Reported
    		 17 17

    End points

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    End points reporting groups
    Reporting group title
    PET/CT imaging with vidoflufolastat (18F).
    Reporting group description
    		 Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan

    Subject analysis set title
    Central Reader 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Central Reading Center 1

    Subject analysis set title
    Central Reader 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Central Reading Center 2

    Subject analysis set title
    Central Reader 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Central Reading Center 3

    Subject analysis set title
    Central Reader 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Central Reading Center 1

    Subject analysis set title
    Central Reader 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Central Reading Center 2

    Subject analysis set title
    Central Reader 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Central Reading Center 3

    Subject analysis set title
    Central Reader 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Central Reader 1

    Subject analysis set title
    Central Reader 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Central Reader 2

    Subject analysis set title
    Central Reader 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Central Reader 3

    Primary: Patient-level sensitivity of vidoflufolastat (18F) - % Sensitivity

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    End point title
    		 Patient-level sensitivity of vidoflufolastat (18F) - % Sensitivity [1]
    End point description
    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).
    End point type
    Primary
    End point timeframe
    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
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Not applicable for a single treatment arm study.
    End point values
    		 Central Reader 1 Central Reader 2 Central Reader 3
    Number of subjects analysed
    172
    172
    172
    Units: % Sensitivity
        number (confidence interval 95%)
    88.8 (83.00 to 93.09)
    88.2 (82.32 to 92.62)
    86.8 (80.74 to 91.56)
    No statistical analyses for this end point

    Primary: Region-level specificity of vidoflufolastat (18F) - % Specificity

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    End point title
    		 Region-level specificity of vidoflufolastat (18F) - % Specificity [2]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    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
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Not applicable for a single treatment arm study.
    End point values
    		 Central Reader 1 Central Reader 2 Central Reader 3
    Number of subjects analysed
    172
    172
    172
    Units: % Specificity
        number (confidence interval 95%)
    97.1 (92.74 to 99.20)
    97.1 (92.74 to 99.20)
    97.1 (92.74 to 99.20)
    No statistical analyses for this end point

    Secondary: Patient-level specificity of vidoflufolastat (18F) - % Specificity

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    End point title
    		 Patient-level specificity of vidoflufolastat (18F) - % Specificity
    End point description
    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
    End point type
    Secondary
    End point timeframe
    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
    End point values
    		 Central Reader 1 Central Reader 2 Central Reader 3
    Number of subjects analysed
    172
    172
    172
    Units: % Specificity
        number (confidence interval 95%)
    0.0 (0.0 to 70.76)
    33.3 (0.84 to 90.57)
    20.0 (0.51 to 71.64)
    No statistical analyses for this end point

    Secondary: Patient-level positive predictive value of vidoflufolastat (18F)

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    End point title
    		 Patient-level positive predictive value of vidoflufolastat (18F)
    End point description
    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))
    End point type
    Secondary
    End point timeframe
    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
    End point values
    		 Central Reader 1 Central Reader 2 Central Reader 3
    Number of subjects analysed
    172
    172
    172
    Units: % Positive Predictive Value
        number (confidence interval 95%)
    98.0 (94.38 to 99.59)
    98.7 (95.30 to 99.84)
    97.3 (93.27 to 99.26)
    No statistical analyses for this end point

    Secondary: Patient-level accuracy of vidoflufolastat (18F)

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    End point title
    		 Patient-level accuracy of vidoflufolastat (18F)
    End point description
    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)
    End point type
    Secondary
    End point timeframe
    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
    End point values
    		 Central Reader 1 Central Reader 2 Central Reader 3
    Number of subjects analysed
    172
    172
    172
    Units: % Negative Predictive Value
        number (confidence interval 95%)
    87.2 (81.28 to 91.81)
    87.2 (81.28 to 91.81)
    84.9 (78.64 to 89.88)
    No statistical analyses for this end point

    Secondary: Patient-level negative predictive value of vidoflufolastat (18F)

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    End point title
    		 Patient-level negative predictive value of vidoflufolastat (18F)
    End point description
    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))
    End point type
    Secondary
    End point timeframe
    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
    End point values
    		 Central Reader 1 Central Reader 2 Central Reader 3
    Number of subjects analysed
    172
    172
    172
    Units: % Negative Predictive Value
        number (confidence interval 95%)
    0.0 (0.0 to 17.65)
    4.8 (0.12 to 23.82)
    4.3 (0.11 to 21.95)
    No statistical analyses for this end point

    Secondary: Region-level Sensitivity of vidoflufolastat (18F) - % Sensitivity

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    End point title
    		 Region-level Sensitivity of vidoflufolastat (18F) - % Sensitivity
    End point description
    Proportion of PLN regions that test positive on both vidoflufolastat (18F) and SoT (TP) among those that are SoT positive (TP+FN)
    End point type
    Secondary
    End point timeframe
    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
    End point values
    		 Central Reader 1 Central Reader 2 Central Reader 3
    Number of subjects analysed
    172
    172
    172
    Units: % Sensitivity
        number (confidence interval 95%)
    20.6 (8.70 to 37.90)
    23.5 (10.75 to 41.17)
    20.6 (8.70 to 37.90)
    No statistical analyses for this end point

    Secondary: Region-level positive predictive value of vidoflufolastat (18F)

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    End point title
    		 Region-level positive predictive value of vidoflufolastat (18F)
    End point description
    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))
    End point type
    Secondary
    End point timeframe
    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
    End point values
    		 Central Reader 1 Central Reader 2 Central Reader 3
    Number of subjects analysed
    172
    172
    172
    Units: % Positive Predictive Value
        number (confidence interval 95%)
    63.6 (30.79 to 89.07)
    66.7 (34.89 to 90.08)
    63.6 (30.79 to 89.07)
    No statistical analyses for this end point

    Secondary: Region-level accuracy of vidoflufolastat (18F)

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    End point title
    		 Region-level accuracy of vidoflufolastat (18F)
    End point description
    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)
    End point type
    Secondary
    End point timeframe
    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
    End point values
    		 Central Reader 1 Central Reader 2 Central Reader 3
    Number of subjects analysed
    172
    172
    172
    Units: % Negative Predictive Value
        number (confidence interval 95%)
    82.0 (75.40 to 87.41)
    82.6 (76.05 to 87.91)
    82.0 (75.40 to 87.41)
    No statistical analyses for this end point

    Secondary: Region-level negative predictive value of vidoflufolastat (18F)

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    End point title
    		 Region-level negative predictive value of vidoflufolastat (18F)
    End point description
    Proportion of PLN regions that are SoT and vidoflufolastat (18F) negative (TN) among those regions that test negative on vidoflufolastat (18F) (TN+FN)
    End point type
    Secondary
    End point timeframe
    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
    End point values
    		 Central Reader 1 Central Reader 2 Central Reader 3
    Number of subjects analysed
    172
    172
    172
    Units: % Negative Predictive Value
        number (confidence interval 95%)
    83.2 (76.55 to 88.65)
    83.8 (77.10 to 89.10)
    83.2 (76.55 to 88.65)
    No statistical analyses for this end point

    Secondary: Region-level sensitivity of vidoflufolastat (18F) scan with standard of truth excluding Pelvic Lymph Node (PLN) metastasis < 2 mm

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    End point title
    		 Region-level sensitivity of vidoflufolastat (18F) scan with standard of truth excluding Pelvic Lymph Node (PLN) metastasis < 2 mm
    End point description
    Sensitivity of vidoflufolastat (18F) PET imaging in the PLN region, excluding from the analysis those lymph nodes showing metastasis <2mm (micro-metastasis)
    End point type
    Secondary
    End point timeframe
    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
    End point values
    		 Central Reader 1 Central Reader 2 Central Reader 3
    Number of subjects analysed
    172
    172
    172
    Units: % Negative Predictive Value
        number (confidence interval 95%)
    26.9 (11.57 to 47.79)
    30.8 (14.33 to 51.79)
    26.9 (11.57 to 47.79)
    No statistical analyses for this end point

    Secondary: Overview of adverse events

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    End point title
    		 Overview of adverse events
    End point description
    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. AEs = Adverse Events
    End point type
    Secondary
    End point timeframe
    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.
    End point values
    		 PET/CT imaging with vidoflufolastat (18F).
    Number of subjects analysed
    184
    Units: Participants
        Adverse events
    24
        Treatment-related Adverse events
    1
        Serious adverse events
    2
        Serious adverse events Treatment-related
    0
        Fatal serious adverse events
    0
        Fatal serious adverse events Treatment-related
    0
        AEs leading to dose adjustment / interruption
    0
        Adverse events requiring additional therapy
    5
    No statistical analyses for this end point

    Secondary: Detection of distant metastasis of vidoflufolastat (18F) scan - Participants with at least one distant metastatic lesion (%)

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    End point title
    		 Detection of distant metastasis of vidoflufolastat (18F) scan - Participants with at least one distant metastatic lesion (%)
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    		 Central Reader 1 Central Reader 2 Central Reader 3
    Number of subjects analysed
    184
    184
    184
    Units: Participants
    7
    11
    7
    No statistical analyses for this end point

    Secondary: vidoflufolastat (18F) scan inter-reader variability - Number of scans agreed

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    End point title
    		 vidoflufolastat (18F) scan inter-reader variability - Number of scans agreed
    End point description
    Scan inter-reader variability is defined the agreement rate among reader determination of vidoflufolastat (18F) images.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    		 PET/CT imaging with vidoflufolastat (18F).
    Number of subjects analysed
    184
    Units: Participants
        Number of scans agreed by all three readers
    163
        Number of scans agreed by two readers
    21
    No statistical analyses for this end point

    Secondary: vidoflufolastat (18F) scan inter-reader variability - %

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    End point title
    		 vidoflufolastat (18F) scan inter-reader variability - %
    End point description
    Scan inter-reader variability is defined the agreement rate among reader determination of vidoflufolastat (18F) images.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    		 PET/CT imaging with vidoflufolastat (18F).
    Number of subjects analysed
    184
    Units: % variability
        number (confidence interval 95%)
    63.9 (55.52 to 72.20)
    No statistical analyses for this end point

    Secondary: vidoflufolastat (18F) scan intra-reader variability

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    End point title
    		 vidoflufolastat (18F) scan intra-reader variability
    End point description
    Scan intra-reader variability is defined as the within-reader agreement rate of vidoflufolastat (18F) images.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    		 Central Reader 1 Central Reader 2 Central Reader 3
    Number of subjects analysed
    20
    20
    20
    Units: variability (%)
        number (confidence interval 95%)
    100 (100 to 100)
    100 (100 to 100)
    89.4 (69.04 to 100)
    No statistical analyses for this end point

    Secondary: Observed maximum blood concentration (Cmax) of vidoflufolastat (18F)

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    End point title
    		 Observed maximum blood concentration (Cmax) of vidoflufolastat (18F)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
    End point values
    		 PET/CT imaging with vidoflufolastat (18F).
    Number of subjects analysed
    10
    Units: kBq/mL
        arithmetic mean (standard deviation)
    49.0 ( 19.2 )
    No statistical analyses for this end point

    Secondary: Time of maximum observed blood concentration occurrence (Tmax) of vidoflufolastat (18F)

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    End point title
    		 Time of maximum observed blood concentration occurrence (Tmax) of vidoflufolastat (18F)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
    End point values
    		 PET/CT imaging with vidoflufolastat (18F).
    Number of subjects analysed
    10
    Units: kBq/mL
        median (full range (min-max))
    0.0333 (0.0167 to 0.0833)
    No statistical analyses for this end point

    Secondary: Area under the vidoflufolastat (18F) concentration-time curve from time zero to the time of last quantifiable concentration (AUClast)

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    End point title
    		 Area under the vidoflufolastat (18F) concentration-time curve from time zero to the time of last quantifiable concentration (AUClast)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
    End point values
    		 PET/CT imaging with vidoflufolastat (18F).
    Number of subjects analysed
    10
    Units: h*kBq/mL
        arithmetic mean (standard deviation)
    47.9 ( 11.9 )
    No statistical analyses for this end point

    Secondary: Volume of distribution during the terminal phase following intravenous elimination (Vz) of vidoflufolastat (18F)

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    End point title
    		 Volume of distribution during the terminal phase following intravenous elimination (Vz) of vidoflufolastat (18F)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
    End point values
    		 PET/CT imaging with vidoflufolastat (18F).
    Number of subjects analysed
    1
    Units: Liters
        arithmetic mean (standard deviation)
    14.9 ( 999 )
    No statistical analyses for this end point

    Secondary: Urinary excretion of radioactivity expressed as a percentage of injected activity (%IA) of vidoflufolastat (18F)

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    End point title
    		 Urinary excretion of radioactivity expressed as a percentage of injected activity (%IA) of vidoflufolastat (18F)
    End point description
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 PET/CT imaging with vidoflufolastat (18F).
    Number of subjects analysed
    10
    Units: Hours
    arithmetic mean (standard deviation)
        0 HRS INJECTION/PRE-INJECTION
    0.000821 ( 0.00120 )
        0 HRS (INJECTION) - T (IMAGE STARTING TIME)
    15.8 ( 11.9 )
        IMAGE ACQUISITION STARTING TIME T - 3 H
    11.9 ( 8.30 )
        3 H - 5 H
    10.5 ( 8.06 )
    No statistical analyses for this end point

    Secondary: Half-Life Lambda z of vidoflufolastat (18F)

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    End point title
    		 Half-Life Lambda z of vidoflufolastat (18F)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
    End point values
    		 PET/CT imaging with vidoflufolastat (18F).
    Number of subjects analysed
    1
    Units: hours
        arithmetic mean (standard deviation)
    1.34 ( 999 )
    No statistical analyses for this end point

    Secondary: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) of vidoflufolastat (18F)

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    End point title
    		 Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) of vidoflufolastat (18F)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post infusion)
    End point values
    		 PET/CT imaging with vidoflufolastat (18F).
    Number of subjects analysed
    1
    Units: h*kBq/mL
        arithmetic mean (standard deviation)
    50.0 ( 999 )
    No statistical analyses for this end point

    Secondary: Total systemic clearance for intravenous administration (CL) of vidoflufolastat (18F)

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    End point title
    		 Total systemic clearance for intravenous administration (CL) of vidoflufolastat (18F)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
    End point values
    		 PET/CT imaging with vidoflufolastat (18F).
    Number of subjects analysed
    1
    Units: L/h
        arithmetic mean (standard deviation)
    7.70 ( 999 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    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.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    		 All Subjects

    Serious adverse events
    		 All Subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 184 (1.09%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Myocardial ischaemia
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Sepsis syndrome
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All Subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 184 (12.50%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Amylase increased
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Vascular disorders
    Hot flush
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Hypertension
         subjects affected / exposed
    5 / 184 (2.72%)
         occurrences all number
    5
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    2 / 184 (1.09%)
         occurrences all number
    2
    Neuropathy peripheral
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    2 / 184 (1.09%)
         occurrences all number
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Feeling hot
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Scrotal oedema
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Skin discolouration
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Renal and urinary disorders
    Urinary incontinence
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1
    COVID-19
         subjects affected / exposed
    1 / 184 (0.54%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Dec 2021
    The main purpose of the amendment was to update the inclusion criterion on the definition of high-risk prostate cancer per D'Amico classification to also include participants with clinical stage T2c or higher at initial diagnosis (instead of T2c only) as they were also considered high-risk per D’Amico classification. Other clarifications and corrections of discrepancies or errors were implemented across the protocol.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com for complete trial results.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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