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    Clinical Trial Results:
    [18F]PSMA-11 PET/CT for prostate cancer – phase 3 clinical trial

    Summary
    EudraCT number
    		 2018-003168-29
    Trial protocol
    		 BE  
    Global end of trial date
    20 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Dec 2021
    First version publication date
    05 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2018/003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03911310
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Corneel Heymanslaan 10, Gent, Belgium, 9000
    Public contact
    Kathia De Man, Ghent University Hospital, 0032 093325461, kathia.deman@uzgent.be
    Scientific contact
    Kathia De Man, Ghent University Hospital, 0032 093325461, kathia.deman@uzgent.be
    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
    20 Sep 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the position of [18F]PSMA-11 PET/CT within the field of available radiotracers for diagnosis of prostate cancer. For this, the diagnostic performances of [18F]PSMA-11 will be compared to those of the current state-of-the-art radiotracer [68Ga]PSMA-11.
    Protection of trial subjects
    - 18F]PSMA-11 and [68Ga]PSMA-11 are injected in a very low quantity to perform the PET scans. Consequently, product-related adverse reactions are not to be expected. - as CT contrast is used in this trial, allergic reactions or a tempory slight reduction in kidney function might occur. In this regard, patients with a history of anaphylactic shock after CT contrast, as well as patients with a serum creatinine concentration > 2.0 mg/dL or estimated glomerular filtration rate < 30 ml/min, are not allowed to participate in this trial. In addition, the renal risk is further reduced by keeping the dose of contrast medium as low as possible during the study (dose calculation based on weight class) and keeping the patient sufficiently hydrated. - The study drug taken in this study may pose an unprecedented risk to an embryo or foetus. Therefore, it is important that the patient avoid pregnancy with a partner and to use contraception (using a condom and possibly additional contraception by the partner) for up to 90 days after the study. The patients participating in this trial also commit to tell their partner that they are participating in this study and to inform the partner of the possible risk to the unborn child. - Both the PET and the CT scan use ionising radiation, which leads to a certain radiation exposure for the patient. Although the patient received 2 PET/CT scans, radiation exposure is minimized by performing only one diagnostic CT scan, and by promoting excretion of the radiotracer. - in case the patient experiences any discomfort, the patient will receive appropriate treatment
    Background therapy
    		 - Iodixanol CT contrast --> to perform the diagnostic CT scan - Furosemide (in case that patient is not contra-indicated) --> to promote diuresis after radiotracer administration - physiological saline --> to promote diuresis after radiotracer administration
    Evidence for comparator
    		 Comparator: [68Ga]PSMA-11 evidence: Bois F, Noirot C, Dietemann S, et al. [68Ga]Ga-PSMA-11 in prostate cancer: a comprehensive review. Am J Nucl Med Mol Imaging. 2020;10(6):349-374. Published 2020 Dec 15.
    Actual start date of recruitment
    25 Apr 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 96
    Worldwide total number of subjects
    96
    EEA total number of subjects
    96
    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)
    19
    From 65 to 84 years
    77
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 - a maximum of 12 weeks was foreseen between the time of signing the informed consent and acquiring both ([18F]PSMA-11 and [68Ga]PSMA-11) PET/CT scans.

    Pre-assignment
    Screening details
    		 Inclusion criteria: Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after previous treatment, or at primary diagnosis and staging Exclusion criteria: Age < 18 years - Physically or mentally unfit to perform the sequential procedures - Refusal of patient to be informed about accidental f

    Period 1
    Period 1 title
    PET CT scans (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Data analyst
    Blinding implementation details
    Concerning the order of the PET scans, half of the patients will be first scanned (= 1st period) with [18F]PSMA-11 and subsequently (=2nd period, maximum three weeks later) with [68Ga]PSMA-11. The scan order in the remaining group of patients will be reversed. Identity of the PET scans will be blind to the patients, the recruiting physicians, and the nuclear medicine physicians interpreting the images. Therefore, after PET/CT reconstruction, raditracer identity details are deleted.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ga-PSMA / F-PSMA
    Arm description
    		 1st PET CT scan: 68Ga-PSMA-11 2nd PET CT scan: 18F-PSMA-11
    Arm type
    		 comparator followed by experimental

    Investigational medicinal product name
    68Ga-PSMA-11
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    2.0 +- 0.2 MBq/kg (single bolus intravenous injection)

    Investigational medicinal product name
    18F-PSMA-11
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    2.0 + 0.2 MBq/kg body weight (single intravenous bolus injection)

    Arm title
    		 F-PSMA / Ga-PSMA
    Arm description
    		 1st PET CT: F-PSMA 2nd PET CT: Ga-PSMA
    Arm type
    		 experimental followed by comparator

    Investigational medicinal product name
    18F-PSMA-11
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    2.0 + 0.2 MBq/kg body weight (single intravenous bolus injection)

    Investigational medicinal product name
    68Ga-PSMA-11
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    2.0 +- 0.2 MBq/kg (single bolus intravenous injection)

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: clinical trial coordinators and nuclear department secretary are not blinded as they participate in the randomisation process For safety reasons, the staff members that prepare the individual patient radiotracer dose (syringe) and the staff members that administer the dose are also not blinded. These staff members are not involved in the data analysis process
    Number of subjects in period 1
    		Ga-PSMA / F-PSMA F-PSMA / Ga-PSMA
    Started
    48
    48
    Completed
    43
    42
    Not completed
    5
    6
         Consent withdrawn by subject
    5
    6

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Ga-PSMA / F-PSMA
    Reporting group description
    		 1st PET CT scan: 68Ga-PSMA-11 2nd PET CT scan: 18F-PSMA-11

    Reporting group title
    F-PSMA / Ga-PSMA
    Reporting group description
    		 1st PET CT: F-PSMA 2nd PET CT: Ga-PSMA

    Primary: Evaluation of the non-inferiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion.

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    End point title
    		 Evaluation of the non-inferiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion.
    End point description
    The non-inferiority of [18F]PSMA-11 will be investigated based on a Tango's score two-sided 95% confidence interval (CI) for a difference of proportions of positive scans of [18F]PSMA-11 compared to [68Ga]PSMA-11 with matched pairs. Non-inferiority will be concluded if the lower limit of this CI is larger than 0.10 (non-inferiority limit).
    End point type
    Primary
    End point timeframe
    0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
    End point values
    		 Ga-PSMA / F-PSMA F-PSMA / Ga-PSMA
    Number of subjects analysed
    42
    40
    Units: confidence interval
    42
    42
    Statistical analysis title
    		 Tango's score two-sided 95% confidence interval (C
    Statistical analysis description
    Non-inferiority of 18F-PSMA-11 was investigated based on a Tango's score two-sided 95% confidence interval (CI) for a difference of proportions of positive scans of 18F-PSMA-11 compared to 68Ga-PSMA-11 with matched pairs. Non-inferiority was concluded if the lower limit of this CI is larger than -0.10 (non-inferiority limit).
    Comparison groups
    F-PSMA / Ga-PSMA v Ga-PSMA / F-PSMA
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 confidence interval
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.045
         upper limit
    		 0.045
    Notes
    [1] - 82 patients included in the trial. (period 1 Ga-PSMA and period 2 F-PSMA comprise the same group of patients; period 1 F-PSMA and period 2 Ga-PSMA comprise the same group of patients)

    Secondary: Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion

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    End point title
    		 Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion
    End point description
    Superiority of 18F-PSMA-11 compared to 68Ga-PSMA-11 with respect to the number of positive PET scans was statistically assessed by applying a McNemar’s test on the proportions of positive PET scans in each group. Hereby, superiority was defined as a difference of minimum 10% in the proportions of positive PET scans (18F-PSMA-11 > 68Ga-PSMA-11).
    End point type
    Secondary
    End point timeframe
    0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11]
    End point values
    		 Ga-PSMA / F-PSMA F-PSMA / Ga-PSMA
    Number of subjects analysed
    42
    40
    Units: p-value
        number (not applicable)
    42
    40
    Statistical analysis title
    		 McNemar’s test
    Statistical analysis description
    McNemar’s test on the proportions of positive PET scans in each group. Hereby, superiority is defined as a difference of minimum 10% in the proportions of positive PET scans (18F-PSMA-11 > 68Ga-PSMA-11).
    Comparison groups
    Ga-PSMA / F-PSMA v F-PSMA / Ga-PSMA
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 confidence interval
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.045
         upper limit
    		 0.045

    Secondary: Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the total number of suspected prostate cancer lesions in corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) scans

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    End point title
    		 Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the total number of suspected prostate cancer lesions in corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) scans
    End point description
    The Wilcoxon signed rank test was applied to investigate differences (number of suspected prostate cancer lesions and scoring of corresponding suspected lesions) between 18F-PSMA-11 and 68Ga-PSMA-11 scans. Hereby, the superiority was defined as a difference of minimum 10% (18F-PSMA-11 > 68Ga-PSMA-11).
    End point type
    Secondary
    End point timeframe
    0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
    End point values
    		 Ga-PSMA / F-PSMA F-PSMA / Ga-PSMA
    Number of subjects analysed
    42
    40
    Units: p-value
        number (not applicable)
    42
    40
    Statistical analysis title
    		 Wilcoxon signed rank
    Statistical analysis description
    The Wilcoxon signed rank test was applied to investigate differences with regard to the number of suspected prostate cancer lesions between 18F-PSMA-11 and 68Ga-PSMA-11 scans. Hereby, the superiority was defined as a difference of minimum 10% (18F-PSMA-11 > 68Ga-PSMA-11).
    Comparison groups
    Ga-PSMA / F-PSMA v F-PSMA / Ga-PSMA
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.431 [2]
    Method
    		 Wilcoxon Signed rank
    Confidence interval
    Notes
    [2] - no statistical difference was found

    Secondary: Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the scoring of corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) suspected lesions

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    End point title
    		 Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the scoring of corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) suspected lesions
    End point description
    The Wilcoxon signed rank test was applied to investigate differences (number of suspected prostate cancer lesions and scoring of corresponding suspected lesions) between 18F-PSMA-11 and 68Ga-PSMA-11 scans. Hereby, the superiority was defined as a difference of minimum 10% (18F-PSMA-11 > 68Ga-PSMA-11).
    End point type
    Secondary
    End point timeframe
    0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
    End point values
    		 Ga-PSMA / F-PSMA F-PSMA / Ga-PSMA
    Number of subjects analysed
    42
    40
    Units: p-value
        number (not applicable)
    42
    40
    Statistical analysis title
    		 Wilcoxon signed rank
    Statistical analysis description
    The Wilcoxon signed rank test was applied to investigate differences with regard to scoring of corresponding suspected lesions between 18F-PSMA-11 and 68Ga-PSMA-11 scans. Hereby, the superiority was defined as a difference of minimum 10% (18F-PSMA-11 > 68Ga-PSMA-11).
    Comparison groups
    Ga-PSMA / F-PSMA v F-PSMA / Ga-PSMA
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.024 [3]
    Method
    		 Wilcoxon Signed rank
    Confidence interval
    Notes
    [3] - as p< 0.05 --> statistically significant result

    Secondary: Descriptive evaluation of [18F]PSMA-11 compared to [68Ga]PSMA

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    End point title
    		 Descriptive evaluation of [18F]PSMA-11 compared to [68Ga]PSMA
    End point description
    Descriptive evaluation of the results of the scan analysis (number of lesions, impact on TNM score, ...)
    End point type
    Secondary
    End point timeframe
    Time Frame: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
    End point values
    		 Ga-PSMA / F-PSMA F-PSMA / Ga-PSMA
    Number of subjects analysed
    42
    40
    Units: number of lesions, miTNM score
        number (not applicable)
    42
    40
    No statistical analyses for this end point

    Secondary: Evaluation of the diagnostic specificity of [18F]PSMA-11 compared to [68Ga]PSMA-11

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    End point title
    		 Evaluation of the diagnostic specificity of [18F]PSMA-11 compared to [68Ga]PSMA-11
    End point description
    This endpoint will be evaluated in a descriptive way, more specifically by a description of the number of positive scans (and/or positive lesions) that can be confirmed via an anatomopathological diagnosis, changes in PSA concentration or via MRI, and by comparison of these numbers between [18F]PSMA-11 and [68Ga]PSMA-11.
    End point type
    Secondary
    End point timeframe
    0 to 180 days post [18F]PSMA-11 and [68Ga]PSMA-11 administration
    End point values
    		 Ga-PSMA / F-PSMA F-PSMA / Ga-PSMA
    Number of subjects analysed
    42
    40
    Units: sensitivity
        number (not applicable)
    42
    40
    No statistical analyses for this end point

    Secondary: Evaluation of the safety of [18F]PSMA-11 administration: CTCAE 4.0 criteria

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    End point title
    		 Evaluation of the safety of [18F]PSMA-11 administration: CTCAE 4.0 criteria
    End point description
    Adverse events will be reported and scored (CTCAE 4.0 criteria) between the first dose administration of trial medication and the last trial related activity. From the time of radiotracer injection till completion of the PET/CT scan (for both [18F]PSMA-11 and [68Ga]PSMA-11), the site staff will visually observe and actively ask the patient whether or not he has observed any adverse effects. Although [18F]PSMA-11 is totally eliminated from the body within 9 hours post injection (= 10 x half-life of 47 ± 5 minutes), AE's occurring up to 24h after the second PET/CT scan will also be handled as such if spontaneously reported by the patient to the investigator.
    End point type
    Secondary
    End point timeframe
    0 to 24 h post [18F]PSMA-11 and [68Ga]PSMA-11 administration
    End point values
    		 Ga-PSMA / F-PSMA F-PSMA / Ga-PSMA
    Number of subjects analysed
    42
    40
    Units: CTCAE 4.0
        number (not applicable)
    42
    40
    No statistical analyses for this end point

    Secondary: Assessment of the interobserver variability with regard to the evaluation of the [18F]PSMA-11 and [68Ga]PSMA-11 PET scans

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    End point title
    		 Assessment of the interobserver variability with regard to the evaluation of the [18F]PSMA-11 and [68Ga]PSMA-11 PET scans
    End point description
    This endpoint will be evaluated by determining a Light's kappa value
    End point type
    Secondary
    End point timeframe
    0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
    End point values
    		 Ga-PSMA / F-PSMA F-PSMA / Ga-PSMA
    Number of subjects analysed
    42
    40
    Units: light's kappa value
        number (not applicable)
    42
    40
    Statistical analysis title
    		 Light's kappa value
    Statistical analysis description
    For the interobserver variability with regard to the evaluation of the 18F-PSMA-11 and 68Ga-PSMA-11 PET scans, a Light’s Kappa value was determined.
    Comparison groups
    Ga-PSMA / F-PSMA v F-PSMA / Ga-PSMA
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.00326
    Method
    		 light's kappa
    Parameter type
    		 lights kappa
    Point estimate
    0.6375
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4587
         upper limit
    		 0.8162

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    0 to 24 h post [18F]PSMA-11 and [68Ga]PSMA-11 administration
    Adverse event reporting additional description
    AE's will be reported and scored between the first dose administration of trial medication and the last trial related activity. Active questioning for AE's during period that patient is at clinical trial site. Passive follow-up of AE's reported by the patient until 24 hours after 2nd PET/CT scan.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Nausea
    Reporting group description
    		 Nausea after CT contrast

    Serious adverse events
    		 Nausea
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 85 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Nausea
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 85 (1.18%)
    Gastrointestinal disorders
    Nausea
    Additional description: Nausea and vomiting tendencies after administration of CT contrast (grade 1 CTCAE)
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences all number
    86

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    11 drop-outs : 9 drop-outs before any study related handlings, 2 drop-outs after the first PET/CT scan (transport issue and loss of interest) scans of 2 patients not included in the analysis due to motion artefacts and technical issues
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    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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