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    Clinical Trial Results:
    NEPTUNE: A Randomised Phase II Study of Neoadjuvant TAK-700 and Leuprorelin Acetate versus Surgery Alone in Intermediate and High Risk Clinically Localized Prostate Cancer

    Summary
    EudraCT number
    2012-000478-42
    Trial protocol
    GB  
    Global end of trial date
    16 Jun 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Sep 2016
    First version publication date
    04 Sep 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    008285QM
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Queen Mary University of London
    Sponsor organisation address
    5 Walden Street, London, United Kingdom, E1 2EF
    Public contact
    Marjia Monsur, Centre for Experimental Cancer Medicine, Queen Mary University of London, London, EC1M 6BQ, +44 02078827351, bci-neptune@qmul.ac.uk
    Scientific contact
    Professor Tom Powles, Centre for Experimental Cancer Medicine, Queen Mary University of London, London, EC1M 6BQ, +44 02078828493, bci-neptune@qmul.ac.uk
    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
    01 Jun 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jun 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate if neoadjuvant TAK-700 with LHRH agonists and prostatectomy is associated with an improvement in progression-free survival compared to prostatectomy alone. The primary endpoint will assess the 3 year biochemical progression free survival (PSA)
    Protection of trial subjects
    Both drugs are associated with side effects. These are on the whole due to testosterone reductions in the body. The side effects such as hot flushes and fatigue are common. Erectile dysfunction, which commonly occurs with the prostate surgery could be made worse. Specific side effects associated with orteronel such as swelling can also occur. This was closely monitored during and after the study. Patients on the study arm were required to attend clinic every 4 weeks whilst they were on study medication where adverse events were recorded. The patient information sheet included details on expected adverse events for patients to look out for and also details that unexpected events may occur.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Mar 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
    United Kingdom: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    7
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Between 5/6/13 and 12/6/14, 16 patients in the United Kingdom with Intermediate and High Risk Clinically Localised Prostate Cancer were recruited to the NEPTUNE study.

    Pre-assignment
    Screening details
    Inclusion criteria included patients with intermediate and high risk clinically localised prostate cancer who had received no previous treatment. 16 patients were randomised (1:1) prior to the early termination of this study.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Neoadjuvant TAK-700,leuprorelin acetate and prostatectomy
    Arm description
    Neoadjuvant TAK-700, leuprorelin acetate and prostatectomy
    Arm type
    Experimental

    Investigational medicinal product name
    TAK-700 (Orteronel)
    Investigational medicinal product code
    Other name
    TAK-700, Orteronel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300mg BID (Daily total dose 600mg) for 24 week period until prostatectomy

    Investigational medicinal product name
    Leuprorelin Acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use, Subcutaneous use
    Dosage and administration details
    3.75mg every 28 days until prostatectomy

    Arm title
    Prostatectomy alone
    Arm description
    Prostatectomy alone
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    Neoadjuvant TAK-700,leuprorelin acetate and prostatectomy Prostatectomy alone
    Started
    6
    10
    Completed
    6
    10

    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
    16 16
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    7 7
        From 65-84 years
    9 9
        85 years and over
    0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    64.2 (61.5 to 68.7) -
    Gender categorical
    Units: Subjects
        Male
    16 16
    Gleason Score
    Units: Subjects
        3+4
    8 8
        4+3
    3 3
        4+4
    3 3
        4+5
    2 2
    T-stage
    Units: Subjects
        T2a
    4 4
        T2c
    2 2
        T3a
    8 8
        T3b
    2 2
    Prostate cancer risk
    Units: Subjects
        Intermediate
    4 4
        High
    12 12
    Planned Surgery Type
    Units: Subjects
        Robotic
    14 14
        Other
    2 2
    Performance Status
    Units: Subjects
        ECOG 1
    3 3
        ECOG 0
    13 13
    PSA
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    9.6 (7.4 to 23.5) -

    End points

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    End points reporting groups
    Reporting group title
    Neoadjuvant TAK-700,leuprorelin acetate and prostatectomy
    Reporting group description
    Neoadjuvant TAK-700, leuprorelin acetate and prostatectomy

    Reporting group title
    Prostatectomy alone
    Reporting group description
    Prostatectomy alone

    Primary: Biochemical Progression Free Survival

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    End point title
    Biochemical Progression Free Survival [1]
    End point description
    Assess the 3 year biochemical progression free survival (PSA) defined as a post-operative serum PSA of greater or equal to 0.2 ng/dl on 2 separate occasions as defined by the AUA.
    End point type
    Primary
    End point timeframe
    From registration until progression
    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: Due to early termination of the study due to IMP withdrawal from development by the manufacturer, there is insufficient data to perform analysis of this endpoint.
    End point values
    Neoadjuvant TAK-700,leuprorelin acetate and prostatectomy Prostatectomy alone
    Number of subjects analysed
    6
    10
    Units: weeks
    6
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From date of consent to 30 days post surgery
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    -

    Serious adverse events
    Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 16 (6.25%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 16 (25.00%)
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    General disorders and administration site conditions
    Back pain
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Palmer Plantar Erythema
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Hot flush
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 16 (6.25%)
         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
    04 Dec 2013
    -Addition of a participating site -Updated IMPD -Changes to the screening procedures- MRI can occur within 16 weeks of randomisation instead of 4 weeks. -Changes to the time frame in which sites provide screening biopsy to within 8 weeks of randomisation
    26 Jun 2014
    -Change of Principal Investigator
    22 Sep 2014
    -Implementation of a temporary halt - A manufacturing stop in place concerning the investigational medicinal product ortenerol (TAK-700) by Millenium (Takeda) -Amended Investigators Brochure (updated safety information) -Updated Leuprorelin label

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    22 Sep 2014
    Halt to recruitment implemented in Substantial Amendment 3. A manufacturing stop was put in place concerning the investigational medicinal product ortenerol (TAK-700) by Millenium (Takeda). Recruiting sites were asked to discontinue providing information sheets for the Neptune study to prospective trial patients. Takeda agreed to provide study medication to all patients who were still on treatment and for those patients who had been given a patient information sheet prior to the temporary halt coming into effect. Patients on treatment completed their treatment schedule as per protocol. The end of study notification was submitted to the Competent Authority once the last patient on treatment had completed the follow up period.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Small numbers precluded any meaningful analysis of any protocol-specified endpoints.
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