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    Clinical Trial Results:
    Metabolic changes due to iatrogenic hypogonadism in patients with prostate cancer: orchiectomy vs. triptorelin

    Summary
    EudraCT number
    		 2013-002553-29
    Trial protocol
    		 DK  
    Global end of trial date
    12 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Nov 2021
    First version publication date
    29 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    kk-2013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Urology
    Sponsor organisation address
    Borgmester Ib Juuls vej 23, Herlev, Denmark, 2730
    Public contact
    Department of Urology, Herlev Hospi, Department of Urology, Herlev Hospital, 0045 38681505, peter.busch.oestergren@regionh.dk
    Scientific contact
    Department of Urology, Herlev Hospi, Department of Urology, Herlev Hospital, 0045 38681505, peter.busch.oestergren@regionh.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
    12 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Is to investigate if the modality of Androgen deprivation therapy is of importance when looking at body composition, glucose- and lipid metabolism.
    Protection of trial subjects
    This was a phase IV trial comparing 2 well known treatments (surgical orchiectomy vs. triptorelin). Patients were monitored closely for any AEs and SAEs.
    Background therapy
    		 None
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2013
    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: 58
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    4
    From 65 to 84 years
    52
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 58 patients were recruited from september 18 2013 until April 3 2015. 78 patients were screened for eligibility. All screening and inclusion was done from a single center in Denmark.

    Pre-assignment
    Screening details
    		 Principle inclusion criteria: 1. diagnosed prostate cancer, where life long ADT is indicated. 2. Age 18 - 90 Years. 3. ECOG Performance status O-2 Principal exclusion criteria: 1. Previous androgen deprivation therapy. 2. Known diabetes mellitus or HbA1c> 48.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was not blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Subcapsular orchiectomy
    Arm description
    		 Subcapsular orchiectomy
    Arm type
    		 Surgical comparator

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Triptorelin
    Arm description
    		 Triptorelin 22.5 mg intramuscular every 24 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Triptorelin
    Investigational medicinal product code
    PR1
    Other name
    Pamorelin
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intramuscular use
    Dosage and administration details
    22.5mg every 24 weeks

    Number of subjects in period 1
    		Subcapsular orchiectomy Triptorelin
    Started
    29
    29
    Completed
    23
    25
    Not completed
    6
    4
         Consent withdrawn by subject
    1
    -
         Disease progression
    4
    4
         Diabetes mellitus
    1
    -

    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
    		 58 58
    Age categorical
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Elligible men were between the age of 18 to 90 years
    Units: years
        arithmetic mean (standard deviation)
    		 73 ( 7.5 ) -
    Gender categorical
    Men with prostate cancer
    Units: Subjects
        Female
    		 0 0
        Male
    		 58 58

    End points

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    End points reporting groups
    Reporting group title
    Subcapsular orchiectomy
    Reporting group description
    		 Subcapsular orchiectomy

    Reporting group title
    Triptorelin
    Reporting group description
    		 Triptorelin 22.5 mg intramuscular every 24 weeks

    Primary: Fasting plasma glucose

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    End point title
    		 Fasting plasma glucose
    End point description
    End point type
    Primary
    End point timeframe
    Measured at baseline, 12, 24 and 48 weeks
    End point values
    		 Subcapsular orchiectomy Triptorelin
    Number of subjects analysed
    28
    29
    Units: mmol/L
        arithmetic mean (standard deviation)
    6.0 ( 0.7 )
    6.1 ( 0.7 )
    Attachments
    		 Between group differences in changed glucose measu
    Statistical analysis title
    		 Between group difference in fasting glucose
    Statistical analysis description
    Linear mixed models using generalized least squares were used to analyse the between-group differences in the changes in the primary endpoint with repeated measures data.
    Comparison groups
    Subcapsular orchiectomy v Triptorelin
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.4

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse event assessment was done from trial start (01.09.2013 until 48 weeks after last patient was included (04.03.2015)
    Adverse event reporting additional description
    AEs were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Entire cohort
    Reporting group description
    		 Men undergoin either orchiectomy or triptorelin injection therapy

    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: Only SAE were systematically reported to sponsor as this was a phase IV trial comparing two well known, and approved, modalities of androgen deprivation therapy (orchiectomy vs. triptorelin).
    Serious adverse events
    		 Entire cohort
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 57 (24.56%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Investigations
    All SAE
         subjects affected / exposed
    14 / 57 (24.56%)
         occurrences causally related to treatment / all
    1 / 35
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Entire cohort
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 57 (0.00%)

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30388320
    http://www.ncbi.nlm.nih.gov/pubmed/27939836
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