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    Clinical Trial Results:
    Phase III study for evaluation of the diagnostic performance of [18F]CTT1057 PET imaging in patients with prostate cancer with rising PSA levels [biochemical recurrence (BCR)] (GuidePath)

    Summary
    EudraCT number
    		 2020-003959-16
    Trial protocol
    		 FR   ES  
    Global end of trial date
    23 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Dec 2024
    First version publication date
    08 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAAA405A12301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04838613
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma, AG
    Sponsor organisation address
    CH 4002, 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
    23 Nov 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives were: • Evaluate the region-level Correct localization rate (CLR) of vidoflufolastat (18F) • Evaluate the patient-level Positive predictive value (PPV) (with anatomical localization) of vidoflufolastat (18F)
    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
    30 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: 69
    Country: Number of subjects enrolled
    Spain: 104
    Country: Number of subjects enrolled
    Switzerland: 12
    Country: Number of subjects enrolled
    United States: 5
    Worldwide total number of subjects
    190
    EEA total number of subjects
    173
    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)
    66
    From 65 to 84 years
    123
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 190 participants were randomized using a 1:1 ratio to receive either Sequence 1 (vidoflufolastat (18F) followed by gallium (68Ga) gozetotide; N= 96) or Sequence 2 (gallium (68Ga) gozetotide followed by vidoflufolastat (18F); N=94). Out of the 190 randomized participants, 169 completed the study.

    Pre-assignment
    Screening details
    		 Prior to participation in the study, patients had to have biopsy proven prostate adenocarcinoma and diagnosis of biochemical recurrence following initial definitive therapy with either radical prostatectomy or curative intent radiation therapy.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence 1: Vidoflufolastat(18F) then gallium (68Ga)gozetotide
    Arm description
    		 All eligible participants were assigned to this PET/CT scan sequence 1 at random in a 1:1 ratio: - Sequence 1: vidoflufolastat (18F) on Day 1 (investigational imaging agent of interest) followed by gallium (68Ga) gozetotide at least 14 days apart (as part of CTS if required, and for secondary endpoint)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gallium (68Ga) gozetotide
    Investigational medicinal product code
    AAA517
    Other name
    [68Ga]Ga-PSMA-11
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    This drug was injected as a single intravenous injection of approximately 150 MBq (range 111 - 185 MBq).

    Investigational medicinal product name
    vidoflufolastat (18F)
    Investigational medicinal product code
    AAA405
    Other name
    [18F]CTT1057
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    This drug was injected as a single intravenous dose of approximately 370 MBq (range 266 - 407 MBq).

    Arm title
    		 Sequence 2: Gallium(68Ga) gozetotide then vidoflufolastat(18F)
    Arm description
    		 All eligible participants were assigned to the following PET/CT scan sequence 2 at random in a 1:1 ratio: - Sequence 2: gallium (68Ga) gozetotide (as part of CTS if required, and for secondary endpoint) on Day 1 followed by vidoflufolastat (18F) (investigational imaging agent of interest) at least 14 days apart
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gallium (68Ga) gozetotide
    Investigational medicinal product code
    AAA517
    Other name
    [68Ga]Ga-PSMA-11
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    This drug was injected as a single intravenous injection of approximately 150 MBq (range 111 - 185 MBq).

    Investigational medicinal product name
    vidoflufolastat (18F)
    Investigational medicinal product code
    AAA405
    Other name
    [18F]CTT1057
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    This drug was injected as a single intravenous dose of approximately 370 MBq (range 266 - 407 MBq).

    Number of subjects in period 1
    		Sequence 1: Vidoflufolastat(18F) then gallium (68Ga)gozetotide Sequence 2: Gallium(68Ga) gozetotide then vidoflufolastat(18F)
    Started
    96
    94
    Completed
    88
    81
    Not completed
    8
    13
         Consent withdrawn by subject
    3
    6
         Physician decision
    2
    -
         Protocol Deviation
    3
    2
         Technical Problems
    -
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sequence 1: Vidoflufolastat(18F) then gallium (68Ga)gozetotide
    Reporting group description
    		 All eligible participants were assigned to this PET/CT scan sequence 1 at random in a 1:1 ratio: - Sequence 1: vidoflufolastat (18F) on Day 1 (investigational imaging agent of interest) followed by gallium (68Ga) gozetotide at least 14 days apart (as part of CTS if required, and for secondary endpoint)

    Reporting group title
    Sequence 2: Gallium(68Ga) gozetotide then vidoflufolastat(18F)
    Reporting group description
    		 All eligible participants were assigned to the following PET/CT scan sequence 2 at random in a 1:1 ratio: - Sequence 2: gallium (68Ga) gozetotide (as part of CTS if required, and for secondary endpoint) on Day 1 followed by vidoflufolastat (18F) (investigational imaging agent of interest) at least 14 days apart

    Reporting group values
    		 Sequence 1: Vidoflufolastat(18F) then gallium (68Ga)gozetotide Sequence 2: Gallium(68Ga) gozetotide then vidoflufolastat(18F) Total
    Number of subjects
    		 96 94 190
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 34 32 66
        From 65-84 years
    		 62 61 123
        85 years and over
    		 0 1 1
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 66.8 ( 7.59 ) 67.6 ( 8.09 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 0 0 0
        Male
    		 96 94 190
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 31 32 63
        Not Hispanic or Latino
    		 54 54 108
        Unknown or Not Reported
    		 11 8 19
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 87 93 180
        Black or African American
    		 3 1 4
        Asian
    		 2 0 2
        Unknown
    		 4 0 4
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) includes all randomized participants.

    Subject analysis set title
    Efficacy Analysis Set (EFF) - Central Reader 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Efficacy Analysis Set (EFF) included all randomized participants who received vidoflufolastat(18F) and have both an evaluable vidoflufolastat(18F) PET/CT scan imaging, and at least one evaluable CTS assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures. Results are reported independently for each of the three central readers.

    Subject analysis set title
    Efficacy Analysis Set (EFF) - Central Reader 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Efficacy Analysis Set (EFF) included all randomized participants who received vidoflufolastat(18F) and have both an evaluable vidoflufolastat(18F) PET/CT scan imaging, and at least one evaluable CTS assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures. Results are reported independently for each of the three central readers.

    Subject analysis set title
    Efficacy Analysis Set (EFF) - Central Reader 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Efficacy Analysis Set (EFF) included all randomized participants who received vidoflufolastat(18F) and have both an evaluable vidoflufolastat(18F) PET/CT scan imaging, and at least one evaluable CTS assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures. Results are reported independently for each of the three central readers.

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    F-SAF included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)).

    Subject analysis set title
    Gallium (68Ga) gozetotide safety Set (Ga-SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Ga-SAF included all participants who received Gallium (68Ga) gozetotide.

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    F-SAF included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)).

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    For intra-reader variability endpoint, scans for a subset of 19 patients from the vidoflufolastat (18F) safety set were read by each reader at 2 different time points. Results were reported independently for each of the three central readers.

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    For intra-reader variability endpoint, scans for a subset of 19 patients from the vidoflufolastat (18F) safety set were read by each reader at 2 different time points. Results were reported independently for each of the three central readers.

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    For intra-reader variability endpoint, scans for a subset of 19 patients from the vidoflufolastat (18F) safety set were read by each reader at 2 different time points. Results were reported independently for each of the three central readers.

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF) Central Reader 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    F-SAF included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)). Results were reported independently for each of the three central readers for some secondary endpoints.

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    F-SAF included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)). Results were reported independently for each of the three central readers for some secondary endpoints.

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    F-SAF included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)). Results were reported independently for each of the three central readers for some secondary endpoints.

    Subject analysis sets values
    		 Full Analysis Set (FAS) Efficacy Analysis Set (EFF) - Central Reader 1 Efficacy Analysis Set (EFF) - Central Reader 2 Efficacy Analysis Set (EFF) - Central Reader 3 Vidoflufolastat (18F) Safety Set (F-SAF) Gallium (68Ga) gozetotide safety Set (Ga-SAF) Vidoflufolastat (18F) Safety Set (F-SAF) Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 1 Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 2 Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 3 Vidoflufolastat (18F) Safety Set (F-SAF) Central Reader 1 Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 2 Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 3
    Number of subjects
    190
    161
    161
    161
    171
    178
    171
    19
    19
    19
    171
    171
    171
    Age categorical
    Units: Subjects
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    67.2 ( 7.83 )
    67.8 ( )
    73.3 ( )
    67.2 ( )
    ( )
    ( )
    65.5 ( )
    100 ( )
    61.2 ( )
    100 ( )
    49.4 ( )
    50.9 ( )
    54.3 ( )
    Sex: Female, Male
    Units: Participants
        Female
    0
        Male
    190
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    63
        Not Hispanic or Latino
    108
        Unknown or Not Reported
    19
    Race/Ethnicity, Customized
    Units: Subjects
        White
    180
        Black or African American
    4
        Asian
    2
        Unknown
    4

    End points

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    End points reporting groups
    Reporting group title
    Sequence 1: Vidoflufolastat(18F) then gallium (68Ga)gozetotide
    Reporting group description
    		 All eligible participants were assigned to this PET/CT scan sequence 1 at random in a 1:1 ratio: - Sequence 1: vidoflufolastat (18F) on Day 1 (investigational imaging agent of interest) followed by gallium (68Ga) gozetotide at least 14 days apart (as part of CTS if required, and for secondary endpoint)

    Reporting group title
    Sequence 2: Gallium(68Ga) gozetotide then vidoflufolastat(18F)
    Reporting group description
    		 All eligible participants were assigned to the following PET/CT scan sequence 2 at random in a 1:1 ratio: - Sequence 2: gallium (68Ga) gozetotide (as part of CTS if required, and for secondary endpoint) on Day 1 followed by vidoflufolastat (18F) (investigational imaging agent of interest) at least 14 days apart

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) includes all randomized participants.

    Subject analysis set title
    Efficacy Analysis Set (EFF) - Central Reader 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Efficacy Analysis Set (EFF) included all randomized participants who received vidoflufolastat(18F) and have both an evaluable vidoflufolastat(18F) PET/CT scan imaging, and at least one evaluable CTS assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures. Results are reported independently for each of the three central readers.

    Subject analysis set title
    Efficacy Analysis Set (EFF) - Central Reader 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Efficacy Analysis Set (EFF) included all randomized participants who received vidoflufolastat(18F) and have both an evaluable vidoflufolastat(18F) PET/CT scan imaging, and at least one evaluable CTS assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures. Results are reported independently for each of the three central readers.

    Subject analysis set title
    Efficacy Analysis Set (EFF) - Central Reader 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Efficacy Analysis Set (EFF) included all randomized participants who received vidoflufolastat(18F) and have both an evaluable vidoflufolastat(18F) PET/CT scan imaging, and at least one evaluable CTS assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures. Results are reported independently for each of the three central readers.

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    F-SAF included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)).

    Subject analysis set title
    Gallium (68Ga) gozetotide safety Set (Ga-SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Ga-SAF included all participants who received Gallium (68Ga) gozetotide.

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    F-SAF included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)).

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    For intra-reader variability endpoint, scans for a subset of 19 patients from the vidoflufolastat (18F) safety set were read by each reader at 2 different time points. Results were reported independently for each of the three central readers.

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    For intra-reader variability endpoint, scans for a subset of 19 patients from the vidoflufolastat (18F) safety set were read by each reader at 2 different time points. Results were reported independently for each of the three central readers.

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    For intra-reader variability endpoint, scans for a subset of 19 patients from the vidoflufolastat (18F) safety set were read by each reader at 2 different time points. Results were reported independently for each of the three central readers.

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF) Central Reader 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    F-SAF included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)). Results were reported independently for each of the three central readers for some secondary endpoints.

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    F-SAF included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)). Results were reported independently for each of the three central readers for some secondary endpoints.

    Subject analysis set title
    Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    F-SAF included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)). Results were reported independently for each of the three central readers for some secondary endpoints.

    Primary: Region-level correct localization rate (CLR) of vidoflufolastat (18F)

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    End point title
    		 Region-level correct localization rate (CLR) of vidoflufolastat (18F) [1]
    End point description
    Region-level correct localization rate (CLR) is defined as the percentage of regions containing at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings within the same region, out of all regions containing at least one PET-positive finding.
    End point type
    Primary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    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: No formal comparison was done between central readers. The lower bound of the 95% confidence interval was compared against the predefined threshold for each central reader.
    End point values
    		 Efficacy Analysis Set (EFF) - Central Reader 1 Efficacy Analysis Set (EFF) - Central Reader 2 Efficacy Analysis Set (EFF) - Central Reader 3
    Number of subjects analysed
    161
    161
    161
    Units: Percentage of regions
        number (confidence interval 95%)
    67.8 (54.44 to 78.75)
    73.3 (60.79 to 82.98)
    67.2 (55.13 to 77.30)
    No statistical analyses for this end point

    Primary: Patient-level positive predictive value (PPV) (with anatomical localization) of vidoflufolastat (18F)

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    End point title
    		 Patient-level positive predictive value (PPV) (with anatomical localization) of vidoflufolastat (18F) [2]
    End point description
    Patient-level positive predictive value (PPV) is defined as the percentage of participants who have at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all participants who are PET/CT scan positive.
    End point type
    Primary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    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: No formal comparison was done between central readers. The lower bound of the 95% confidence interval was compared against the predefined threshold for each central reader.
    End point values
    		 Efficacy Analysis Set (EFF) - Central Reader 1 Efficacy Analysis Set (EFF) - Central Reader 2 Efficacy Analysis Set (EFF) - Central Reader 3
    Number of subjects analysed
    161
    161
    161
    Units: Percentage of participants
        number (confidence interval 95%)
    67.8 (54.36 to 79.38)
    74.5 (61.00 to 85.33)
    66.7 (53.31 to 78.31)
    No statistical analyses for this end point

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

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    End point title
    		 Patient-level sensitivity of vidoflufolastat (18F)
    End point description
    Patient-level sensitivity is defined as the percentage of participants who test positive on vidoflufolastat (18F) and Composite Truth Standard (CTS) (True Positive (TP)) among those that are CTS positive (True Positive (TP) or False Negative (FN)).
    End point type
    Secondary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    End point values
    		 Efficacy Analysis Set (EFF) - Central Reader 1 Efficacy Analysis Set (EFF) - Central Reader 2 Efficacy Analysis Set (EFF) - Central Reader 3
    Number of subjects analysed
    161
    161
    161
    Units: Percentage of participants
        number (confidence interval 95%)
    66.7 (53.31 to 78.31)
    68.3 (55.04 to 79.74)
    66.7 (53.31 to 78.31)
    No statistical analyses for this end point

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

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    End point title
    		 Patient-level negative predictive value (NPV) of vidoflufolastat (18F)
    End point description
    Patient-level negative predictive value is defined as the percentage of participants who are both vidoflufolastat (18F) and CTS negative (True Negative (TN)) among those who test negative on vidoflufolastat (18F) (True Negative (TN) or False Negative (FN)).
    End point type
    Secondary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    End point values
    		 Efficacy Analysis Set (EFF) - Central Reader 2 Efficacy Analysis Set (EFF) - Central Reader 3
    Number of subjects analysed
    161
    161
    Units: Percentage of participants
        number (confidence interval 95%)
    82.1 (73.43 to 88.85)
    80.2 (71.09 to 87.46)
    No statistical analyses for this end point

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

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    End point title
    		 Patient-level specificity of vidoflufolastat (18F)
    End point description
    Patient-level specificity is defined as the percentage of participants who test negative on vidoflufolastat (18F) and CTS (True Negative (TN)) among those that are CTS negative (True Negative (TN) or False Positive (FP)).
    End point type
    Secondary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    End point values
    		 Efficacy Analysis Set (EFF) - Central Reader 1 Efficacy Analysis Set (EFF) - Central Reader 2 Efficacy Analysis Set (EFF) - Central Reader 3
    Number of subjects analysed
    161
    161
    161
    Units: Percentage of participants
        number (confidence interval 95%)
    81.2 (72.19 to 88.28)
    86.1 (77.84 to 92.21)
    80.2 (71.09 to 87.46)
    No statistical analyses for this end point

    Secondary: Patient-level detection rate

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    End point title
    		 Patient-level detection rate
    End point description
    Patient-level detection rate is defined as the percentage of participants who have at least one PET positive lesion, regardless of True Positive (TP) or False Positive (FP) findings, out of all participants who are scanned.
    End point type
    Secondary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    End point values
    		 Efficacy Analysis Set (EFF) - Central Reader 1 Efficacy Analysis Set (EFF) - Central Reader 2 Efficacy Analysis Set (EFF) - Central Reader 3
    Number of subjects analysed
    161
    161
    161
    Units: Percentage of participants
        number (confidence interval 95%)
    36.6 (29.20 to 44.59)
    34.2 (26.88 to 42.04)
    37.3 (29.79 to 45.23)
    No statistical analyses for this end point

    Secondary: Patient-level correct detection rate (CDR)

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    End point title
    		 Patient-level correct detection rate (CDR)
    End point description
    Patient-level correct detection rate (CDR) is defined as the percentage of participants who have at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all participants who are scanned.
    End point type
    Secondary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    End point values
    		 Efficacy Analysis Set (EFF) - Central Reader 1 Efficacy Analysis Set (EFF) - Central Reader 2 Efficacy Analysis Set (EFF) - Central Reader 3
    Number of subjects analysed
    161
    161
    161
    Units: Percenage of participants
        number (confidence interval 95%)
    24.8 (18.38 to 32.26)
    25.5 (18.94 to 32.92)
    24.8 (18.38 to 32.26)
    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
    Patient-level accuracy is defined as the percentage of participants who are CTS and vidoflufolastat (18F) positive (True Positive (TP)) and negative (True Negative (TN)) among those participants that identified on vidoflufolastat (18F) (True Positive (TP), True Negative (TN), False Positive (FP) or False Negative (FN)).
    End point type
    Secondary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    End point values
    		 Efficacy Analysis Set (EFF) - Central Reader 1 Efficacy Analysis Set (EFF) - Central Reader 2 Efficacy Analysis Set (EFF) - Central Reader 3
    Number of subjects analysed
    161
    161
    161
    Units: Percentage of participants
        number (confidence interval 95%)
    75.8 (68.41 to 82.17)
    79.5 (72.44 to 85.45)
    75.2 (67.74 to 81.62)
    No statistical analyses for this end point

    Secondary: Region-level sensitivity of vidoflufolastat (18F) (Overall)

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    End point title
    		 Region-level sensitivity of vidoflufolastat (18F) (Overall)
    End point description
    Region level sensitivity is defined as the percentage of regions that test positive on both vidoflufolastat (18F) and CTS (True Positive (TP)) among those regions that are CTS positive (True Positive (TP) or False Negative (FN)).
    End point type
    Secondary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    End point values
    		 Efficacy Analysis Set (EFF) - Central Reader 1 Efficacy Analysis Set (EFF) - Central Reader 2 Efficacy Analysis Set (EFF) - Central Reader 3
    Number of subjects analysed
    161
    161
    161
    Units: Percentage of regions
        number (confidence interval 95%)
    58.2 (46.69 to 68.81)
    54.3 (43.44 to 64.80)
    57.0 (45.69 to 67.60)
    No statistical analyses for this end point

    Secondary: Region level specificity of vidoflufolastat (18F)

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    End point title
    		 Region level specificity of vidoflufolastat (18F)
    End point description
    Region level specificity is defined as the percentage of regions that test negative on both vidoflufolastat (18F) and CTS (True Negative (TN)) among those regions that are CTS negative (False Positive (FP) or True Negative (TN)).
    End point type
    Secondary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    End point values
    		 Efficacy Analysis Set (EFF) - Central Reader 1 Efficacy Analysis Set (EFF) - Central Reader 2 Efficacy Analysis Set (EFF) - Central Reader 3
    Number of subjects analysed
    161
    161
    161
    Units: Percentage of regions
        number (confidence interval 95%)
    97.0 (95.44 to 98.04)
    97.8 (96.42 to 98.64)
    97.0 (95.44 to 98.00)
    No statistical analyses for this end point

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

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    End point title
    		 Region level negative predictive value (NPV) of vidoflufolastat (18F)
    End point description
    Region level negative predictive value is defined as the percentage of regions that are CTS and vidoflufolastat (18F) negative (True Negative (TN)) among those regions that test negative on vidoflufolastat (18F) (True Negative (TN) or False Negative (FN)).
    End point type
    Secondary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    End point values
    		 Efficacy Analysis Set (EFF) - Central Reader 1 Efficacy Analysis Set (EFF) - Central Reader 2 Efficacy Analysis Set (EFF) - Central Reader 3
    Number of subjects analysed
    161
    161
    161
    Units: Percentage of regions
        number (confidence interval 95%)
    95.5 (93.75 to 96.82)
    95.0 (93.22 to 96.38)
    95.4 (93.61 to 96.75)
    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
    Region level accuracy is defined as the percentage of regions that are CTS andvidoflufolastat (18F) positive (True Positive (TP)) and negative (True Negative (TN)) among those regions that identified on vidoflufolastat (18F) (True Positive (TP), True Negative (TN), False Positive (FP) and False Negative (FN)).
    End point type
    Secondary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    End point values
    		 Efficacy Analysis Set (EFF) - Central Reader 1 Efficacy Analysis Set (EFF) - Central Reader 2 Efficacy Analysis Set (EFF) - Central Reader 3
    Number of subjects analysed
    161
    161
    161
    Units: Percentage of regions
        number (confidence interval 95%)
    93.2 (91.18 to 94.74)
    93.4 (91.48 to 94.94)
    93.0 (91.07 to 94.61)
    No statistical analyses for this end point

    Secondary: Patient-level positive predictive value (PPV) of vidoflufolastat (18F) related to PSA levels

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    End point title
    		 Patient-level positive predictive value (PPV) of vidoflufolastat (18F) related to PSA levels
    End point description
    Patient-level positive predictive value related to PSA levels is defined as the percentage of participants who have at least one True Positive (TP) lesion (exactly anatomically localized correspondence between vidoflufolastat (18F) PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all participants who are vidoflufolastat (18F) positive, stratified by PSA levels. This endpoint was analyzed in each of the following subgroups: PSA ≤ 0.5 ng/mL; 0.5 ng/mL<PSA≤1 ng/mL; 1 ng/mL<PSA≤2 ng/mL; 2 ng/mL<PSA≤5 ng/mL; PSA > 5 ng/mL.
    End point type
    Secondary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    End point values
    		 Efficacy Analysis Set (EFF) - Central Reader 1 Efficacy Analysis Set (EFF) - Central Reader 2 Efficacy Analysis Set (EFF) - Central Reader 3
    Number of subjects analysed
    161
    161
    161
    Units: Percentage of Participants
    number (confidence interval 95%)
        Subgroup: PSA <= 0.5 ng/mL (n = 100,100,100)
    59.3 (38.80 to 77.61)
    61.5 (40.57 to 79.77)
    51.9 (31.95 to 71.33)
        Subgroup: 0.5 ng/mL <PSA <= 1 ng/mL (n=29, 29, 29)
    66.7 (34.89 to 90.08)
    90.9 (58.72 to 99.77)
    81.8 (48.22 to 97.72)
        Subgroup: 1 ng/mL <PSA <= 2 ng/mL (n = 11, 11, 11)
    71.4 (29.04 to 96.33)
    85.7 (42.13 to 99.64)
    62.5 (24.49 to 91.48)
        Subgroup: 2 ng/mL <PSA <= 5 ng/mL (n=11,11,11)
    85.7 (42.13 to 99.64)
    83.3 (35.88 to 99.58)
    87.5 (47.35 to 99.68)
        Subgroup: PSA > 5 ng/mL (n = 6,6,6)
    100 (39.76 to 100)
    100 (39.76 to 100)
    100 (39.76 to 100)
    No statistical analyses for this end point

    Secondary: Overview of Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Overview of Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs)
    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.
    End point type
    Secondary
    End point timeframe
    From first dosing (Day 1) up to 14 days post dosing
    End point values
    		 Vidoflufolastat (18F) Safety Set (F-SAF) Gallium (68Ga) gozetotide safety Set (Ga-SAF)
    Number of subjects analysed
    171
    178
    Units: Participants
        Adverse Events (AEs)
    20
    16
        Treatment-related AEs
    6
    2
        Serious Adverse Events (SAEs)
    1
    0
        Treatment-related SAEs
    0
    0
        Fatal serious AEs
    0
    0
        Treatment-related fatal AEs
    0
    0
        AEs leading to treatment discontinuation
    0
    0
        Treatment-related AEs leading to treatment discont
    0
    0
        AEs leading to dose adjustment / interruption
    0
    0
        AEs requiring additional therapy
    2
    4
    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
    Inter-reader variability is defined as the agreement among three readers determination of vidoflufolastat (18F) images.
    End point type
    Secondary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    End point values
    		 Vidoflufolastat (18F) Safety Set (F-SAF)
    Number of subjects analysed
    171
    Units: % agreement
        number (confidence interval 95%)
    65.5 (56.84 to 74.15)
    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
    Intra-reader variability is defined as the within-reader agreement for two different time points of vidoflufolastat (18F) images.
    End point type
    Secondary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    End point values
    		 Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 1 Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 2 Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 3
    Number of subjects analysed
    19
    19
    19
    Units: % agreement
        number (confidence interval 95%)
    100 (100 to 100)
    61.2 (10.39 to 100)
    100 (100 to 100)
    No statistical analyses for this end point

    Secondary: Concordance between vidoflufolastat (18F) and gallium (68GA) gozetotide for detection of lesions at lesion level using central reads (Overall)

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    End point title
    		 Concordance between vidoflufolastat (18F) and gallium (68GA) gozetotide for detection of lesions at lesion level using central reads (Overall)
    End point description
    Concordance between vidoflufolastat (18F) and gallium (68Ga) gozetotide for detection of PSMA-positive lesions (location and number) using central reads.
    End point type
    Secondary
    End point timeframe
    vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    End point values
    		 Vidoflufolastat (18F) Safety Set (F-SAF) Central Reader 1 Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 2 Vidoflufolastat (18F) Safety Set (F-SAF) - Central Reader 3
    Number of subjects analysed
    171
    171
    171
    Units: Percentage of lesions
        number (confidence interval 95%)
    49.4 (39.78 to 59.00)
    50.9 (40.65 to 61.04)
    54.3 (43.47 to 64.77)
    No statistical analyses for this end point

    Secondary: Change in patient management plans attributed to the vidoflufolastat (18F) PET/CT scan

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    End point title
    		 Change in patient management plans attributed to the vidoflufolastat (18F) PET/CT scan
    End point description
    Change in patient management plans attributed to the PET/CT scan is defined as the percentage of participants who underwent a change in intended treatment plan attributed to the vidoflufolastat (18F) PET/CT scan as assessed by pre and post imaging questionnaires.
    End point type
    Secondary
    End point timeframe
    From randomization up to 14 days after obtaining the results of the vidoflufolastat (18F) PET imaging
    End point values
    		 Vidoflufolastat (18F) Safety Set (F-SAF)
    Number of subjects analysed
    171
    Units: participants
    61
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing.
    Adverse event reporting additional description
    Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Gallium (68Ga) gozetotide safety Set (Ga-SAF)
    Reporting group description
    		 Ga-SAF included all participants who received Gallium (68Ga) gozetotide.

    Reporting group title
    Vidoflufolastat (18F) Safety Set (F-SAF)
    Reporting group description
    		 F-SAF included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)).

    Serious adverse events
    		 Gallium (68Ga) gozetotide safety Set (Ga-SAF) Vidoflufolastat (18F) Safety Set (F-SAF)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 171 (0.58%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Gallium (68Ga) gozetotide safety Set (Ga-SAF) Vidoflufolastat (18F) Safety Set (F-SAF)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 178 (8.99%)
    20 / 171 (11.70%)
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    2 / 178 (1.12%)
    0 / 171 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Thirst
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Injection site warmth
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Asthenia
         subjects affected / exposed
    0 / 178 (0.00%)
    5 / 171 (2.92%)
         occurrences all number
    0
    5
    Respiratory, thoracic and mediastinal disorders
    Tachypnoea
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Apathy
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Amylase increased
         subjects affected / exposed
    0 / 178 (0.00%)
    2 / 171 (1.17%)
         occurrences all number
    0
    2
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 178 (0.56%)
    1 / 171 (0.58%)
         occurrences all number
    1
    1
    Lipase increased
         subjects affected / exposed
    0 / 178 (0.00%)
    3 / 171 (1.75%)
         occurrences all number
    0
    3
    Injury, poisoning and procedural complications
    Wound
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Tendon rupture
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Muscle strain
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 178 (0.56%)
    1 / 171 (0.58%)
         occurrences all number
    1
    1
    Neuropathy peripheral
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Cognitive disorder
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia oral
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Renal pain
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 171 (0.58%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 171 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 178 (0.56%)
    2 / 171 (1.17%)
         occurrences all number
    1
    2

    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 clarify the inclusion criterion on PSA level requirements for confirmation of BCR following RT and following RP to avoid misinterpretation and ensure full alignment with the published definitions for BCR per AUA and ASTRO-Phoenix guidelines and with the targeted study population (participants who had BCR following initial definitive therapy). The amendment also clarified that participants with prior salvage RT or salvage surgery were not eligible for the study to ensure alignment with the targeted participant population.

    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.
    The cohort was mainly European and White, with only 1 site in the US. Low subject numbers in some subgroups precluded analysis. Composite Truth Standard Level 1 was usable from only a small proportion of subjects in this study.
    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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