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    Clinical Trial Results:
    An exploratory, open label, single-arm study to evaluate the effect of Eligard® 6-month on biomarkers of disease in patients with metastatic prostate cancer

    Summary
    EudraCT number
    2012-000101-69
    Trial protocol
    NL  
    Global end of trial date
    05 Aug 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Aug 2016
    First version publication date
    13 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EGD-EC-005
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01933022
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Acronym: EFFECT
    Sponsors
    Sponsor organisation name
    Astellas Pharma Europe Ltd.
    Sponsor organisation address
    2000 Hillswood Drive, Chertsey, Surrey, United Kingdom, KT16 0RS
    Public contact
    Clinical Trial Disclosure, Astellas Pharma Europe Ltd., Astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Trial Disclosure, Astellas Pharma Europe Ltd., Astellas.resultsdisclosure@astellas.com
    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
    05 Aug 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Aug 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To explore the effect of Eligard® on the following prostate cancer biomarkers: 1. Testosterone in serum 2. Prostate Specific Antigen (PSA) in serum 3. Prostate Cancer Antigen 3 (PCA3) in urine 4. PSA Messenger Ribonucleic Acid (mRNA) in blood/Peripheral Blood Mononuclear Cell 5. PCA3 mRNA in blood/PBMC 6. Transmembrane Protease, Serine 2 Erythroblast Transformation- Specific (ETS)-related gene (TMPRSS2-ERG) mRNA in blood/PBMC
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Aug 2014
    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
    Netherlands: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    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)
    1
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This multicenter study was conducted at 5 sites in the Netherlands.

    Pre-assignment
    Screening details
    Participants screened were aged 18 years or older with confirmed metastatic prostate cancer for whom androgen deprivation therapy (ADT) was indicated. 16 participants signed informed consents for entry into the study, of which 14 participants were screen failures.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    This was an open label study.

    Arms
    Arm title
    leuprorelin 45 mg
    Arm description
    Participants received 1 subcutaneous injection of leuprorelin 45 mg 6-months extended release.
    Arm type
    Experimental

    Investigational medicinal product name
    leuprorelin
    Investigational medicinal product code
    EGD
    Other name
    Eligard®, leuprorelin acetate
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Leuprorelin 45 mg (6-month formulation of Leuprorelin acetate) powder and solvent for solution was administered subcutaneously (single dose).

    Number of subjects in period 1
    leuprorelin 45 mg
    Started
    2
    Completed
    1
    Not completed
    1
         Enrolled but did not receive study drug
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    leuprorelin 45 mg
    Reporting group description
    Participants received 1 subcutaneous injection of leuprorelin 45 mg 6-months extended release.

    Reporting group values
    leuprorelin 45 mg Total
    Number of subjects
    2 2
    Age categorical
    The safety analysis set (SAF) was the planned analysis population for baseline characteristics. The SAF would have consisted of all participants who received study drug.
    Units: Subjects
        Adults (18-64 years)
    1 1
        From 65-84 years
    1 1
    Gender categorical
    The SAF was the planned analysis population for baseline characteristics.
    Units:
        Male
    2 2
        Female
    0 0

    End points

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    End points reporting groups
    Reporting group title
    leuprorelin 45 mg
    Reporting group description
    Participants received 1 subcutaneous injection of leuprorelin 45 mg 6-months extended release.

    Primary: Changes from Baseline of Testosterone Levels in Serum

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    End point title
    Changes from Baseline of Testosterone Levels in Serum [1]
    End point description
    The serum testosterone levels were to be determined using Radio Immuno Assay (RIA). Planned analysis of changes from baseline of clinical evaluation variables was not possible due to small sample size (one study participant) and variations in assay results. Therefore there were no clinical evaluation conclusions made.
    End point type
    Primary
    End point timeframe
    Baseline to week 1, 6, 12 and 24
    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: Not applicable, planned analysis not possible, only one participant completed the study.
    End point values
    leuprorelin 45 mg
    Number of subjects analysed
    0 [2]
    Units: nmol/L
        arithmetic mean (standard deviation)
    ±
    Notes
    [2] - Planned analysis not possible due to small sample size (1 participant).
    No statistical analyses for this end point

    Primary: Changes from Baseline of PSA Level in Serum

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    End point title
    Changes from Baseline of PSA Level in Serum [3]
    End point description
    The serum PSA levels were to be determined using immunoassay. Planned analysis of changes from baseline of clinical evaluation variables was not possible due to small sample size (one study participant) and variations in assay results. Therefore there were no clinical evaluation conclusions made.
    End point type
    Primary
    End point timeframe
    Baseline to week 1, 6, 12 and 24
    Notes
    [3] - 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: Not applicable, planned analysis not possible, only one participant completed the study.
    End point values
    leuprorelin 45 mg
    Number of subjects analysed
    0 [4]
    Units: μg/L
        arithmetic mean (standard deviation)
    ±
    Notes
    [4] - Planned analysis not possible due to small sample size (1 participant).
    No statistical analyses for this end point

    Primary: Changes from Baseline of PCA3 Score in Urine

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    End point title
    Changes from Baseline of PCA3 Score in Urine [5]
    End point description
    The urine PCA3 scores were to be determined using the PROGENSA® assay. Planned analysis of changes from baseline of clinical evaluation variables was not possible due to small sample size (one study participant) and variations in assay results. Therefore there were no clinical evaluation conclusions made.
    End point type
    Primary
    End point timeframe
    Baseline to week 1, 6, 12 and 24
    Notes
    [5] - 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: Not applicable, planned analysis not possible, only one participant completed the study.
    End point values
    leuprorelin 45 mg
    Number of subjects analysed
    0 [6]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    Notes
    [6] - Planned analysis not possible due to small sample size (1 participant).
    No statistical analyses for this end point

    Primary: Changes from Baseline of Number of PSA mRNA Copies in Blood/PBMC

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    End point title
    Changes from Baseline of Number of PSA mRNA Copies in Blood/PBMC [7]
    End point description
    The number of PBMC PSA mRNA copies were to be determined by using real time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). Planned analysis of changes from baseline of clinical evaluation variables was not possible due to small sample size (one study participant) and variations in assay results. Therefore there were no clinical evaluation conclusions made.
    End point type
    Primary
    End point timeframe
    Baseline to week 1, 6, 12 and 24
    Notes
    [7] - 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: Not applicable, planned analysis not possible, only one participant completed the study.
    End point values
    leuprorelin 45 mg
    Number of subjects analysed
    0 [8]
    Units: copies/PCR
        arithmetic mean (standard deviation)
    ±
    Notes
    [8] - Planned analysis not possible due to small sample size (1 participant).
    No statistical analyses for this end point

    Primary: Changes from Baseline of Number of PCA3 mRNA Copies in Blood/PBMC

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    End point title
    Changes from Baseline of Number of PCA3 mRNA Copies in Blood/PBMC [9]
    End point description
    The number of PBMC PCA3 mRNA copies were to be determined by using real time RT-PCR. Planned analysis of changes from baseline of clinical evaluation variables was not possible due to small sample size (one study participant) and variations in assay results. Therefore there were no clinical evaluation conclusions made.
    End point type
    Primary
    End point timeframe
    Baseline to week 1, 6, 12 and 24
    Notes
    [9] - 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: Not applicable, planned analysis not possible, only one participant completed the study.
    End point values
    leuprorelin 45 mg
    Number of subjects analysed
    0 [10]
    Units: copies/PCR
        arithmetic mean (standard deviation)
    ±
    Notes
    [10] - Planned analysis not possible due to small sample size (1 participant).
    No statistical analyses for this end point

    Primary: Changes from Baseline of Number of TMPRSS2-ERG mRNA Copies in Blood/PBMC

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    End point title
    Changes from Baseline of Number of TMPRSS2-ERG mRNA Copies in Blood/PBMC [11]
    End point description
    The number of PBMC TMPRSS2-ERG mRNA copies were to be determined by using real time RT-PCR. Planned analysis of changes from baseline of clinical evaluation variables was not possible due to small sample size (one study participant) and variations in assay results. Therefore there were no clinical evaluation conclusions made.
    End point type
    Primary
    End point timeframe
    Baseline to week 1, 6, 12 and 24
    Notes
    [11] - 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: Not applicable, planned analysis not possible, only one participant completed the study.
    End point values
    leuprorelin 45 mg
    Number of subjects analysed
    0 [12]
    Units: copies/PCR
        arithmetic mean (standard deviation)
    ±
    Notes
    [12] - Planned analysis not possible due to small sample size (1 participant).
    No statistical analyses for this end point

    Secondary: Number of Participants with Adverse Events (AEs)

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    End point title
    Number of Participants with Adverse Events (AEs)
    End point description
    The SAF was the planned analysis population for AEs. An Adverse Event (AE) is defined as any untoward medical occurrence in a participant who was administered study drug & which does not necessarily have a causal relationship with the treatment. An AE starting or worsening after first study drug intake will be considered as treatment emergent (TEAE).
    End point type
    Secondary
    End point timeframe
    From first dose of study drug up to end of study (up to 24 weeks)
    End point values
    leuprorelin 45 mg
    Number of subjects analysed
    1
    Units: Participants
        AEs
    1
        Serious Adverse Events (SAEs)
    0
        Drug-related AEs
    0
        Deaths
    0
        AEs leading to permanent discontinuation of drug
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to end of study (up to 24 weeks)
    Adverse event reporting additional description
    The SAF was the planned analysis population for AEs.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Eligard 45 mg
    Reporting group description
    Participants received received 1 subcutaneous injection of Eligard® 45 mg 6-months extended release.

    Serious adverse events
    Eligard 45 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Eligard 45 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Musculoskeletal and connective tissue disorders
    Groin pain
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Arthralgia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Joint swelling
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Apr 2014
    1. Inclusion criterion changed from Positive blood PCA3 mRNA at screening to: Positive blood PSA mRNA at screening 2. Exclusion criterion 3, exclusion criterion 9, Previous Drugs and Therapies, and Concomitant Medication wording were updated to allow use of anti-androgens when used to prevent testosterone flare up, starting from up to 2 weeks prior to Eligard® injection and continuing for up to 3 weeks, according to local treatment guidelines. 3. There were 3 other substantial changes, which were administrative changes such as clarification of terminology and contact detail changes.

    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.
    This study was discontinued/terminated early by the Sponsor due to the lack of feasibility of finding patients meeting all inclusion criteria.
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