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    Clinical Trial Results:
    PHASE III STUDY OF [18F]PSMA-1007 VS FLUOROCHOLINE (18F) PET TO COMPARE THE DETECTION RATE OF PROSTATE CANCER LESIONS IN PATIENTS WITH BIOCHEMICAL RECURRENCE AFTER PREVIOUS DEFINITIVE TREATMENT FOR LOCALIZED PROSTATE CANCER

    Summary
    EudraCT number
    		 2018-002975-16
    Trial protocol
    		 FR  
    Global end of trial date
    08 Oct 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    03 Jul 2022
    First version publication date
    09 Jun 2022
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    correction of patients numbers in End point section

    Trial information

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    Trial identification
    Sponsor protocol code
    ABX-CT-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04102553
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ABX GmbH
    Sponsor organisation address
    Heinrich-Glaeser-Strasse 10-14, Radeberg, Germany, 01454
    Public contact
    Department of Medicinal Chemistry, ABX GmbH, info@abx.de
    Scientific contact
    Department of Medicinal Chemistry, ABX GmbH, info@abx.de
    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
    08 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Oct 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To show, in an independent assessment by 3 readers blinded to clinical data and tracer, the superiority of [18F]PSMA-1007 over Fluorocholine (18F) regarding the detection rate of metastatic prostate cancer lesions (patient-based analysis)
    Protection of trial subjects
    In routine care
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Mar 2019
    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: 200
    Worldwide total number of subjects
    200
    EEA total number of subjects
    200
    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)
    51
    From 65 to 84 years
    149
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Administration of informed consent, evaluation of inclusion/exclusion criteria, medical history.

    Pre-assignment period milestones
    Number of subjects started
    		 200
    Number of subjects completed
    		 200

    Period 1
    Period 1 title
    Screening
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 [18F]PSMA-1007 and Fluorocholine (18F)
    Arm description
    		 Patients received 2 PET scans in randomized order, either [18F]PSMA-1007 PET/CT first, followed by Fluorocholine (18F) PET/CT, or Fluorocholine (18F) PET/CT first, followed by [18F]PSMA-1007 PET/CT (1-10 days apart).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluorocholine (18F)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Fluorocholine (18F) was administered with an activity of 200-400 MBq.

    Investigational medicinal product name
    [18F]PSMA-1007
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    [18F]PSMA-1007 was administered as a single intravenous injection of 3-4 MBq/kg (corresponding to a 210-280 MBq for a 70 kg adult).

    Number of subjects in period 1
    		[18F]PSMA-1007 and Fluorocholine (18F)
    Started
    200
    Completed
    200
    Period 2
    Period 2 title
    Study
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 [18F]PSMA-1007 and Fluorocholine (18F)
    Arm description
    		 Patients received 2 PET scans in randomized order, either [18F]PSMA-1007 PET/CT first, followed by Fluorocholine (18F) PET/CT, or Fluorocholine (18F) PET/CT first, followed by [18F]PSMA-1007 PET/CT (1-10 days apart).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluorocholine (18F)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Fluorocholine (18F) was administered with an activity of 200-400 MBq.

    Investigational medicinal product name
    [18F]PSMA-1007
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    [18F]PSMA-1007 was administered as a single intravenous injection of 3-4 MBq/kg (corresponding to a 210-280 MBq for a 70 kg adult).

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 2 is the baseline period, which refers to actual study procedure.
    Number of subjects in period 2
    		[18F]PSMA-1007 and Fluorocholine (18F)
    Started
    200
    study drug administration
    195
    Completed
    190
    Not completed
    10
         Consent withdrawn by subject
    1
         Physician decision
    8
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study
    Reporting group description
    		 -

    Reporting group values
    		 Study Total
    Number of subjects
    		 200 200
    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)
    		 51 51
        From 65-84 years
    		 149 149
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Male
    		 200 200
        Female
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients enrolled who received either study drug (including those who received Fluorocholine (18F) only)

    Subject analysis set title
    Intent-to-treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients who underwent both PET examinations and completed at least 4 weeks follow-up.

    Subject analysis sets values
    		 Safety Analysis Set Intent-to-treat
    Number of subjects
    195
    190
    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)
    50
    50
        From 65-84 years
    145
    140
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Male
    195
    190
        Female
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    [18F]PSMA-1007 and Fluorocholine (18F)
    Reporting group description
    		 Patients received 2 PET scans in randomized order, either [18F]PSMA-1007 PET/CT first, followed by Fluorocholine (18F) PET/CT, or Fluorocholine (18F) PET/CT first, followed by [18F]PSMA-1007 PET/CT (1-10 days apart).
    Reporting group title
    [18F]PSMA-1007 and Fluorocholine (18F)
    Reporting group description
    		 Patients received 2 PET scans in randomized order, either [18F]PSMA-1007 PET/CT first, followed by Fluorocholine (18F) PET/CT, or Fluorocholine (18F) PET/CT first, followed by [18F]PSMA-1007 PET/CT (1-10 days apart).

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients enrolled who received either study drug (including those who received Fluorocholine (18F) only)

    Subject analysis set title
    Intent-to-treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients who underwent both PET examinations and completed at least 4 weeks follow-up.

    Primary: Detection rate of [18F]PSMA-1007

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    End point title
    		 Detection rate of [18F]PSMA-1007
    End point description
    Patient-based detection rate of all lesions compared with expert panel assessment, as determined in an independent image read with 3 readers blinded to clinical data and tracer.
    End point type
    Primary
    End point timeframe
    6 months follow-up
    End point values
    		 [18F]PSMA-1007 and Fluorocholine (18F) Intent-to-treat
    Number of subjects analysed
    190
    190
    Units: estimate
        number (confidence interval 95%)
    0.7698 (0.7218 to 0.8178)
    0.7698 (0.7218 to 0.8178)
    Statistical analysis title
    		 Odds Ratio [18F]PSMA-1007 vs Fluorocholine (18F)
    Comparison groups
    [18F]PSMA-1007 and Fluorocholine (18F) v Intent-to-treat
    Number of subjects included in analysis
    380
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 z test
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.606
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.9656
         upper limit
    		 3.4549

    Primary: Detection rate of Fluorocholine (18F)

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    End point title
    		 Detection rate of Fluorocholine (18F)
    End point description
    Patient-based detection rate of all lesions compared with expert panel assessment, as determined in an independent image read with 3 readers blinded to clinical data and tracer.
    End point type
    Primary
    End point timeframe
    6 months follow-up
    End point values
    		 [18F]PSMA-1007 and Fluorocholine (18F) Intent-to-treat
    Number of subjects analysed
    190
    190
    Units: estimate
        number (confidence interval 95%)
    0.5651 (0.5071 to 0.6231)
    0.5651 (0.5071 to 0.6231)
    Statistical analysis title
    		 Difference in Proportions of Detection Rate
    Comparison groups
    [18F]PSMA-1007 and Fluorocholine (18F) v Intent-to-treat
    Number of subjects included in analysis
    380
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 z test
    Parameter type
    		 Difference in proportions
    Point estimate
    0.2047
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1465
         upper limit
    		 0.263

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded from the time of the first administration of study drug until 24 hours after the second PET examination. For most patients, this resulted in 1 day of safety follow-up; the maximum follow-up duration for AEs was 13 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    safety analysis set
    Reporting group description
    		 -

    Serious adverse events
    		 safety analysis set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 195 (0.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 safety analysis set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 195 (2.56%)
    Vascular disorders
    arterial hypertension
         subjects affected / exposed
    1 / 195 (0.51%)
         occurrences all number
    1
    General disorders and administration site conditions
    chest discomfort
         subjects affected / exposed
    1 / 195 (0.51%)
         occurrences all number
    1
    Gastrointestinal disorders
    toothache
         subjects affected / exposed
    1 / 195 (0.51%)
         occurrences all number
    1
    diarrhea
         subjects affected / exposed
    1 / 195 (0.51%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    shoulder pain
         subjects affected / exposed
    1 / 195 (0.51%)
         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
    23 Apr 2019
    Protocol version 3.0 (clarifications, typo correction)
    14 Oct 2019
    Protocol version 4.0 (description of study drug, extension of study period, typo correction)

    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.
    This was a cross-over study, therefore results of the endpoints are reported for the intent-to-treat population, consisting of 190 subjects total.
    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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