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    Clinical Trial Results:
    68Ga-PSMA PET/CT vs. 18F-PSMA PET/CT for the diagnosis of metastases in newly diagnosed high-risk prostate cancer patients undergoing radical prostatectomy

    Summary
    EudraCT number
    		 2021-004846-39
    Trial protocol
    		 DK  
    Global end of trial date
    27 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Nov 2025
    First version publication date
    13 Nov 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    N-20200025
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aalborg University Hospital
    Sponsor organisation address
    Hobrovej 18-22, Aalborg, Denmark, 9000
    Public contact
    Department of Nuclear Medicine, Aalborg University Hospital, 0045 97665500, f.gossili@rn.dk
    Scientific contact
    Department of Nuclear Medicine, Aalborg University Hospital, 0045 97665500, f.gossili@rn.dk
    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
    01 Oct 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jun 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary purpose of this study is to compare the diagnostic properties by the two PSMA-ligands (18F-PSMA PET/CT vs 68Ga-PSMA PET/CT) in patients undergoing radical prostatectomy.
    Protection of trial subjects
    Patients underwent scanning by experienced personnel, with experience with clinical trials
    Background therapy
    		 None
    Evidence for comparator
    		 Histopathology of the surgical specimen served as reference standard.
    Actual start date of recruitment
    01 Nov 2021
    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
    Denmark: 57
    Worldwide total number of subjects
    57
    EEA total number of subjects
    57
    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)
    16
    From 65 to 84 years
    41
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were identified at the MDT conference and recruited from Department of Urology, Aalborg University Hospital

    Pre-assignment
    Screening details
    		 Consecutive men with high-risk prostate cancer, classified according to the D’Amico criteria and confirmed histologically as adenocarcinoma, were prospectively enrolled. Eligibility required no evidence of distant metastasis on conventional imaging and a planned radical prostatectomy, as determined by the prostate MDT-conference.

    Pre-assignment period milestones
    Number of subjects started
    		 57
    Number of subjects completed
    		 50

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 7
    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Diagnostic crossover cohort
    Arm description
    		 Study uses a crossover, paired design, there is no traditional “arm titles”
    Arm type
    		 Crossover, paired design

    Investigational medicinal product name
    MV09IX17
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    iv injection

    Number of subjects in period 1 [1]
    		Diagnostic crossover cohort
    Started
    50
    Completed
    50
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 57 were included , but 7 patients withdraw consent prior to the scan ( which was a trial-specific scan)

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 50 50
    Age categorical
    18-64 years: 16 64-84 years: 41
    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)
    		 40 40
        From 65-84 years
    		 10 10
        85 years and over
    		 0 0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 70 ( 3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 50 50
    Subject analysis sets

    Subject analysis set title
    overall trial
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Diagnostic crossover design, and patient were analysed pr. prtocol

    Subject analysis sets values
    		 overall trial
    Number of subjects
    50
    Age categorical
    18-64 years: 16 64-84 years: 41
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    40
        From 65-84 years
    10
        85 years and over
    0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    70 ( 3 )
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    50

    End points

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    End points reporting groups
    Reporting group title
    Diagnostic crossover cohort
    Reporting group description
    		 Study uses a crossover, paired design, there is no traditional “arm titles”

    Subject analysis set title
    overall trial
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Diagnostic crossover design, and patient were analysed pr. prtocol

    Primary: Diagnostic accuracy

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    End point title
    		 Diagnostic accuracy [1]
    End point description
    Sensitivity, specificity, PPV, NPV of 18F-PSMA PET/CT vs 68Ga-PSMA PET/CT for detection of tumor in high-risk prostate cancer, using histopathology reference standards
    End point type
    Primary
    End point timeframe
    finalized statistical analyses by 31st of Decemebr 2025
    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: Diagnostic accuracy in terms of sensitivity, specificity, PPV, NPV and accuracy
    End point values
    		 Diagnostic crossover cohort overall trial
    Number of subjects analysed
    50
    50
    Units: units
    50
    50
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From the administration of the first study radiotracer dose until completion of prostatectomy
    Adverse event reporting additional description
    SAEs/SUSARs within 24 hours, other AEs in periodic reports
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    2021
    Frequency threshold for reporting non-serious adverse events: 0.01%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: THis is a low intervention trial with a PET-tracer given in sub-physiologic amounts - thus absolutely no adverse events were seen in compliance with the reported litterature where more than 50.000 men have been investigated using this tracer

    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.
    None reported
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    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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