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    Clinical Trial Results:
    18FDHT-PET to visualize the effect on the androgen receptor level by bicalutamide

    Summary
    EudraCT number
    		 2015-001634-17
    Trial protocol
    		 NL  
    Global end of trial date
    25 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 May 2022
    First version publication date
    25 May 2022
    Other versions
    Summary report(s)
    		 Paper trial results

    Trial information

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    Trial identification
    Sponsor protocol code
    2015.0704
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02697032
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Medical Center Groningen
    Sponsor organisation address
    Hanzeplein 1, Groningen, Netherlands,
    Public contact
    Department of Medical Oncology, University Medical Center Groningen, +31 503616161, c.p.schroder@umcg.nl
    Scientific contact
    Department of Medical Oncology, University Medical Center Groningen, +31 503616161, c.p.schroder@umcg.nl
    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
    18 Dec 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Feasibility to detect a difference in uptake on 18F-FDHT scan after 4 weeks of treatment with bicalutamide in metastatic breast cancer patients.
    Protection of trial subjects
    no specific measures
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2017
    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
    Netherlands: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    11
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients will be recruited both from the academic center as well as regional hospitals. The patients will be informed by one of the investigators under the supervision of the PI. Patients will be informed with a patient letter and have a week to consider. The written informed consent form should be signed and personally dated by the patient

    Pre-assignment
    Screening details
    		 25 pts signed consent, of which 2 screenfailures and in 1 patient baseline FDHT-PET was performed, but was not treated with bicalutamide. In addition, another patient was treated short-term with bicalutamide and underwent 2x FDHT-PET, however metastasis biopsy showed HER2+, so bicalutamide was discontinued. 21 patients will be included for analysis

    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
    		 patients
    Arm description
    		 At day 0 before start with bicalutamide, a FDHT-PET/CT will be performed, and one after 6 weeks (i.e. 2 weeks after steady-state). The second FDHT-PET will be performed to determine if this scan can be used as a biomarker for early response. Patients will be treated with bicalutamide until progression or unacceptable toxicity is encountered.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bicalutamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg milligram(s) per day buccal use

    Investigational medicinal product name
    16-beta-[18F]fluoro-5-alphadihydrotestosterone
    Investigational medicinal product code
    18F-FDHT
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    up to 200 MBq

    Number of subjects in period 1
    		patients
    Started
    22
    Completed
    22

    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
    		 22 22
    Age categorical
    adults
    Units: Subjects
        Adults (18-64 years)
    		 11 11
        From 65-84 years
    		 11 11
        85 years and over
    		 0 0
    Age continuous
    adults
    Units: years
        median (standard deviation)
    		 65 ( 11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 22
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    patients
    Reporting group description
    		 At day 0 before start with bicalutamide, a FDHT-PET/CT will be performed, and one after 6 weeks (i.e. 2 weeks after steady-state). The second FDHT-PET will be performed to determine if this scan can be used as a biomarker for early response. Patients will be treated with bicalutamide until progression or unacceptable toxicity is encountered.

    Primary: Quantify residual AR binding sites in metastatic breast cancer

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    End point title
    		 Quantify residual AR binding sites in metastatic breast cancer [1]
    End point description
    To quantify residual AR binding sites in metastatic breast cancer after 6 weeks of treatment with bicalutamide.
    End point type
    Primary
    End point timeframe
    6 weeks
    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: see enclosed publication
    End point values
    		 patients
    Number of subjects analysed
    22
    Units: SUV
    22
    No statistical analyses for this end point

    Secondary: Determine changes in 18F-FDHT uptake

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    End point title
    		 Determine changes in 18F-FDHT uptake
    End point description
    To determine whether changes in 18F-FDHT uptake after 6 weeks associates with response to bicalutamide.
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 patients
    Number of subjects analysed
    22
    Units: SUV
    22
    No statistical analyses for this end point

    Secondary: Influence amount of AR tumor expression

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    End point title
    		 Influence amount of AR tumor expression
    End point description
    To determine whether 18F-FDHT tracer uptake is influenced by the amount of AR tumor expression.
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 patients
    Number of subjects analysed
    22
    Units: SUV
    22
    No statistical analyses for this end point

    Secondary: Difference in changes in AR availability

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    End point title
    		 Difference in changes in AR availability
    End point description
    To determine whether changes in AR availability are different for breast cancer subgroups during treatment with bicalutamide
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 patients
    Number of subjects analysed
    22
    Units: SUV
    22
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    during study
    Adverse event reporting additional description
    Adverse events are defined as any undesirable experience occurring to a subject during the study, whether or not considered related to FDHT-PET scan or the treatment of bicalutamide. All adverse events reported spontaneously by the subject or observed by the investiga¬tor or his staff will be recorded.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Toetsing online
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 5%
    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: see enclosed publication

    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.
    described in article

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33341447
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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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