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    Clinical Trial Results:
    Radium-223 in patients with PSA progression and without clinical metastases following maximal local therapy: a pilot study

    Summary
    EudraCT number
    		 2014-002833-70
    Trial protocol
    		 BE  
    Global end of trial date
    12 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Dec 2021
    First version publication date
    22 Dec 2021
    Other versions
    Summary report(s)
    		 manuscript

    Trial information

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    Trial identification
    Sponsor protocol code
    s56892
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Clinical Trial Center (CTC), UZLeuven, 0032 16341998, CTC@uzleuven.be
    Scientific contact
    Clinical Trial Center (CTC), UZLeuven, 0032 16341998, CTC@uzleuven.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
    18 Feb 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the clinical safety/tolerability of Radium-223 treatment in patients affected by prostate cancer with biochemical relapse after maximal local treatment with high risk of metastatic progression. Safety and feasibility results could be used to plan an eventual phase II/III trial.
    Protection of trial subjects
    Subjects had to sign informed consent before starting the study and could leave the study at any time. Subjects were followed clinically by dedicated medical staff and they had free and direct contact with the clinical trial staff in order to permit them to solve any personal, clinical or administrative issue. Patients could contact the medical staff at any time.
    Background therapy
    		 -
    Evidence for comparator
    		 /
    Actual start date of recruitment
    25 Apr 2016
    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
    Belgium: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    2
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 8 patients included in the study at UZLeuven between April 2016 and December 2017.

    Pre-assignment
    Screening details
    		 INCLUSION CRITERIA (main): Male≥ 18 years with histological confirmation of prostatic adenocarcinoma, Biochemical progression following to RP, PLND and adjuvant or salvage EBRT or following to salvage LND in patients treated formerly by RP and adjuvant or salvage EBRT , No metastases on 68 Ga-PSMA-11 PET/CT and whole body MRI.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Single arm.

    Arms
    Arm title
    		 Radium-223 arm
    Arm description
    		 6 injections with Radium-223 (xofigo) every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Radium-223
    Investigational medicinal product code
    Other name
    Xofigo
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    See publication.

    Number of subjects in period 1
    		Radium-223 arm
    Started
    8
    Completed
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Radium-223 arm
    Reporting group description
    		 6 injections with Radium-223 (xofigo) every 4 weeks

    Reporting group values
    		 Radium-223 arm Total
    Number of subjects
    		 8 8
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 2 2
        From 65-84 years
    		 6 6
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 8 8
    Subject analysis sets

    Subject analysis set title
    Treated patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients treated with study drug

    Subject analysis sets values
    		 Treated patients
    Number of subjects
    8
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    2
        From 65-84 years
    6
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    8

    End points

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    End points reporting groups
    Reporting group title
    Radium-223 arm
    Reporting group description
    		 6 injections with Radium-223 (xofigo) every 4 weeks

    Subject analysis set title
    Treated patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients treated with study drug

    Primary: Safety an tolerability

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    End point title
    		 Safety an tolerability [1]
    End point description
    End point type
    Primary
    End point timeframe
    April 2016 to Dec 2020
    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: safety and tolerability are reported in the section adverse events.
    End point values
    		 Radium-223 arm Treated patients
    Number of subjects analysed
    8
    8
    Units: proportion (%)
    8
    8
    No statistical analyses for this end point

    Secondary: Time to PSA progression

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    End point title
    		 Time to PSA progression
    End point description
    End point type
    Secondary
    End point timeframe
    April 2016 to December 2020
    End point values
    		 Radium-223 arm Treated patients
    Number of subjects analysed
    8
    8
    Units: Months
        median (confidence interval 95%)
    5.5 (5.1 to 7.4)
    5.5 (5.1 to 7.4)
    Statistical analysis title
    		 Time to PSA progression
    Comparison groups
    Radium-223 arm v Treated patients
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.1
         upper limit
    		 7.4
    Notes
    [2] - This is a single arm study with a total of 8 patients included in the analyses.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    April 2016 to December 2020
    Adverse event reporting additional description
    see manuscript
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Radium-223 treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Radium-223 treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (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
    		 Radium-223 treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 8 (62.50%)
    Nervous system disorders
    Taste disorder
    Additional description: Metal taste
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 8 (37.50%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 8 (50.00%)
         occurrences all number
    4
    Appetite disorder
    Additional description: Loss of appetite
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Joint effusion
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Arthralgia
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Sep 2015
    - Protocol amendement PART 1 and 2 - PI change from Prof. H. Van Poppel to Prof S. Joniau - IC amended according to different languages - FOLLOW-UP schedule - Investigator Brochure

    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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