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    Clinical Trial Results:
    PRISMA-PET – Primary Staging of Prostate Cancer: A Randomized Controlled Trial Comparing 18F-PSMA-1007 PET/CT to Conventional Imaging.

    Summary
    EudraCT number
    		 2021-000123-12
    Trial protocol
    		 DK  
    Global end of trial date
    21 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 May 2026
    First version publication date
    03 May 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2020110469
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05123300
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    Kløvervænget 47, Odense, Denmark, 5000
    Public contact
    Department of Nuclear Medicine, Odense University Hospital, +45 30171888, malene.grubbe.hildebrandt@rsyd.dk
    Scientific contact
    Department of Nuclear Medicine, Odense University Hospital, +45 30171888, malene.grubbe.hildebrandt@rsyd.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
    22 Jan 2026
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2025
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Men with a newly diagnosed intermediate or high risk (including locally advanced) prostate cancer or a clinical suspicion of metastases based on other findings, and before any treatment is initiated.
    Protection of trial subjects
    None
    Background therapy
    		 None, this is an imaging tracer
    Evidence for comparator
    		 Comparator is a clinically approved and used imaging tracer
    Actual start date of recruitment
    01 Oct 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 20 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 385
    Worldwide total number of subjects
    385
    EEA total number of subjects
    385
    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)
    56
    From 65 to 84 years
    329
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were referred from departments of Urology for staging, and were offered inclusion if deemed eligible

    Pre-assignment
    Screening details
    		 As only relevant subjects were referred, screeening details are not available.

    Period 1
    Period 1 title
    Inclusion and follow-up (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NaF-PET/CT
    Arm description
    		 Patients staged with NaF-PET/CT
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Na[18F]F
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 MBq iv

    Arm title
    		 PSMA-PET
    Arm description
    		 Patients staged with PSMA-PET
    Arm type
    		 Experimental

    Investigational medicinal product name
    [18F]PSMA-1007
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2 MBq/kg, mininum 150 MBq and maximum 300 MBq.

    Number of subjects in period 1
    		NaF-PET/CT PSMA-PET
    Started
    192
    193
    Completed
    186
    188
    Not completed
    6
    5
         Consent withdrawn by subject
    5
    4
         Not meeting the inclusion criteria
    1
    -
         Didi not meet inclusion criteria
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    NaF-PET/CT
    Reporting group description
    		 Patients staged with NaF-PET/CT

    Reporting group title
    PSMA-PET
    Reporting group description
    		 Patients staged with PSMA-PET

    Reporting group values
    		 NaF-PET/CT PSMA-PET Total
    Number of subjects
    		 192 193 385
    Age categorical
    Age at consent, information collected at inclusion
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 37 19 56
        From 65-84 years
    		 155 174 329
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 192 193 385
    Subject analysis sets

    Subject analysis set title
    Progression free survival NaF vs PSMA
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    data on progression / change of treatment regimen / death were registered and compared to the NaF-group

    Subject analysis sets values
    		 Progression free survival NaF vs PSMA
    Number of subjects
    374
    Age categorical
    Age at consent, information collected at inclusion
    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)
    56
        From 65-84 years
    329
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    374

    End points

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    End points reporting groups
    Reporting group title
    NaF-PET/CT
    Reporting group description
    		 Patients staged with NaF-PET/CT

    Reporting group title
    PSMA-PET
    Reporting group description
    		 Patients staged with PSMA-PET

    Subject analysis set title
    Progression free survival NaF vs PSMA
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    data on progression / change of treatment regimen / death were registered and compared to the NaF-group

    Primary: Progression free survival gr A vs gr B

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    End point title
    		 Progression free survival gr A vs gr B [1]
    End point description
    time from inclusion to progression, relapse or death for any reason.
    End point type
    Primary
    End point timeframe
    years
    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: The data analyzes have not been completed yet
    End point values
    		 NaF-PET/CT PSMA-PET Progression free survival NaF vs PSMA
    Number of subjects analysed
    186
    188
    374
    Units: 374
        Number of events
    43
    34
    77
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    No adverse events reported
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Redcap
    Dictionary version
    0
    Reporting groups
    Reporting group title
    NaF-PET
    Reporting group description
    		 Patients scanned with NaF-PET, the comparator

    Reporting group title
    PSMA-PET
    Reporting group description
    		 Staged with PSMA-PET - the intervention

    Serious adverse events
    		 NaF-PET PSMA-PET
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 190 (0.00%)
    0 / 192 (0.00%)
         number of deaths (all causes)
    15
    12
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 NaF-PET PSMA-PET
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 190 (0.00%)
    0 / 192 (0.00%)
    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: No adverse events were reported

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Mar 2022
    A maximum PSA level of 200 ng/ml was introduced as inclusion parametre

    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.
    Further data are to be collected, analyzed and reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/37636207
    http://www.ncbi.nlm.nih.gov/pubmed/41290368
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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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