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    Clinical Trial Results:
    Proof-of-Concept Multicentre, Prospective, Randomised, Open-Label-Parallel-Group Clinical Trial to Assess the Efficacy of Brachytherapy With or Without Hormone Therapy Using Triptorelin 22.5 mg 6-Month Formulation in Patients With Recurrence of Prostate Cancer Previously Treated With Radiotherapy

    Summary
    EudraCT number
    2010-019158-41
    Trial protocol
    ES  
    Global end of trial date
    10 Dec 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Jul 2019
    First version publication date
    21 Jul 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A-92-52014-177
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01374087
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ipsen Pharma, S.A.
    Sponsor organisation address
    Torre Realia, Plaza Europa 41-43, Planta 7, Barcelona, Spain, 08908
    Public contact
    Medical Director, Ipsen Pharma, S.A., clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Ipsen Pharma, S.A., clinical.trials@ipsen.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
    10 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Dec 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the efficacy of brachytherapy versus brachytherapy plus triptorelin 22.5 milligrams (mg) (single injection) in subjects with recurrence of prostate cancer previously treated with radiotherapy. ≥
    Protection of trial subjects
    This study was carried out in full accordance of an Independent Ethics Committee, the standards on informed consent, the Declaration of Helsinki and the Good Clinical Practice directives issued by the International Conference on Harmonisation, as well as by all local regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Nov 2011
    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
    Spain: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects with recurrence of prostate cancer previously treated with radiotherapy were recruited in 11 sites in Spain from November 2011 until December 2014 when the study was prematurely discontinued.

    Pre-assignment
    Screening details
    35 subjects were screened and 3 did not meet inclusion criteria. Of those who met the inclusion criteria and none of the exclusion criteria, 32 were randomised to treatment and 31 received treatment after 1 subject (in the Brachytherapy + Triptorelin arm) withdrew consent.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Brachytherapy
    Arm description
    Subjects were randomised to receive brachytherapy alone, as either a low dose rate ([125]I) or high dose rate ([192]I).
    Arm type
    Brachytherapy

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Brachytherapy + Triptorelin 22.5 mg
    Arm description
    Subjects received brachytherapy as either a low dose rate ([125]I) or high dose rate ([192]I). Subjects also received a single intramuscular injection of 22.5 mg triptorelin at Visit 2 (Day 1).
    Arm type
    Experimental

    Investigational medicinal product name
    Triptorelin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Triptorelin was dispensed as a freeze-dried white to off-white powder and reconstituted using 2 millilitres of water for injections, and immediately administered by intramuscular injection.

    Number of subjects in period 1 [1]
    Brachytherapy Brachytherapy + Triptorelin 22.5 mg
    Started
    16
    15
    Completed
    0
    0
    Not completed
    16
    15
         Adverse event, non-fatal
    1
    -
         Study discontinued
    13
    13
         Disease progression
    2
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 32 subjects were randomised to treatment but only 31 subjects received treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Brachytherapy
    Reporting group description
    Subjects were randomised to receive brachytherapy alone, as either a low dose rate ([125]I) or high dose rate ([192]I).

    Reporting group title
    Brachytherapy + Triptorelin 22.5 mg
    Reporting group description
    Subjects received brachytherapy as either a low dose rate ([125]I) or high dose rate ([192]I). Subjects also received a single intramuscular injection of 22.5 mg triptorelin at Visit 2 (Day 1).

    Reporting group values
    Brachytherapy Brachytherapy + Triptorelin 22.5 mg Total
    Number of subjects
    16 15 31
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    3 4 7
        From 65-84 years
    13 11 24
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    67.75 ± 4.23 67.93 ± 5.28 -
    Gender categorical
    Units: Subjects
        Female
    0 0 0
        Male
    16 15 31

    End points

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    End points reporting groups
    Reporting group title
    Brachytherapy
    Reporting group description
    Subjects were randomised to receive brachytherapy alone, as either a low dose rate ([125]I) or high dose rate ([192]I).

    Reporting group title
    Brachytherapy + Triptorelin 22.5 mg
    Reporting group description
    Subjects received brachytherapy as either a low dose rate ([125]I) or high dose rate ([192]I). Subjects also received a single intramuscular injection of 22.5 mg triptorelin at Visit 2 (Day 1).

    Primary: Biochemical Failure-free Survival (BFFS)

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    End point title
    Biochemical Failure-free Survival (BFFS) [1]
    End point description
    BFFS was determined by a prostate-specific antigen (PSA) increase of 2 nanograms per millilitre (ng/mL) or more in comparison with the pre-study nadir PSA and confirmed in the course of follow-up by a second value 3 weeks later or longer over the 5 year follow-up. Time to BFFS was defined from treatment initiation to the first time when PSA increase of 2 ng/mL was observed.
    End point type
    Primary
    End point timeframe
    From Day 1 (treatment administration) up to 5 years.
    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: No efficacy analysis was performed and therefore no statistical analysis is specified.
    End point values
    Brachytherapy Brachytherapy + Triptorelin 22.5 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Months
    Notes
    [2] - No efficacy analysis was performed.
    [3] - No efficacy analysis was performed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events were collected from treatment initiation (Day 1) to end of the study.
    Adverse event reporting additional description
    The Safety population consisted of all randomised subjects who received at least 1 dose of study medication.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Brachytherapy
    Reporting group description
    Subjects were randomised to receive brachytherapy alone, as either a low dose rate ([125]I) or high dose rate ([192]I).

    Reporting group title
    Brachytherapy + Triptorelin 22.5 mg
    Reporting group description
    Subjects received brachytherapy as either a low dose rate ([125]I) or high dose rate ([192]I). Subjects also received a single intramuscular injection of 22.5 mg triptorelin at Visit 2 (Day 1).

    Serious adverse events
    Brachytherapy Brachytherapy + Triptorelin 22.5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 16 (18.75%)
    2 / 15 (13.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Liver abscess
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Brachytherapy Brachytherapy + Triptorelin 22.5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 16 (68.75%)
    10 / 15 (66.67%)
    Vascular disorders
    Blood pressure inadequately controlled
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Flushing
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Hypertensive crisis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Radiation skin injury
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Suffocation feeling
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Catheter site haemorrhage
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Implant site pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Puncture site pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Anal pruritus
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Anorectal disorder
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Dyspepsia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Proctitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Nipple pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Perineal pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Pruritus genital
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    3 / 16 (18.75%)
    4 / 15 (26.67%)
         occurrences all number
    4
    5
    Haematuria
         subjects affected / exposed
    2 / 16 (12.50%)
    3 / 15 (20.00%)
         occurrences all number
    2
    3
    Hypertonic bladder
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    Incontinence
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Micturition urgency
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Nephropathy toxic
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nocturia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Pollakiuria
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Urinary incontinence
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    2
    2
    Urinary retention
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Erythrasma
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Orchitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Pilonidal cyst
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0

    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.
    The study was prematurely stopped due to slow enrolment and all subjects were withdrawn following study termination in December 2014. Due to the small number of participating subjects no inferential analyses were performed for the efficacy endpoints.
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