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    Clinical Trial Results:
    Randomized phase III study comparing the association of hormone treatment + docetaxel with hormone treatment alone in metastatic prostate cancer

    Summary
    EudraCT number
    		 2004-001984-22
    Trial protocol
    		 BE  
    Global end of trial date
    15 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Oct 2022
    First version publication date
    11 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GETUG 15/0403
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00104715
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Unicancer
    Sponsor organisation address
    101 rue de Tolbiac, Paris, France, 75013
    Public contact
    Nourredine AIT-RAHMOUNE, Unicancer, 33 1 71 93 67 04, n.ait-rahmoune@unicancer.fr
    Scientific contact
    Nourredine AIT-RAHMOUNE, Unicancer, 33 1 71 93 67 04, n.ait-rahmoune@unicancer.fr
    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
    15 May 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the GETUG15 study is to compare the 3-year overall survival (OS) of metastatic prostate cancers patients treated with first-line chemotherapy (docetaxel) + androgen deprivation therapy (ADT) to those treated only with ADT.
    Protection of trial subjects
    In order to ensure the protection of the rights, safety and well-being of trial subjects, this clinical trial was conducted in accordance with the Declaration of Helsinki (1964) and subsequent amendments, ICH Good Clinical Practice Guidelines (CPMP/ICH/135/95), the European Directive (2001/20/CE) and the applicable local regulatory requirements and laws. Furthermore, an independent Ethics Committees reviewed and gave a favorable opinion to the study documents, including the initial protocol and all subsequent amendments, and all information and documents provided to subjects/patients. Written informed consent was obtained from all patients prior to enrollment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Oct 2004
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 4 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    France: 383
    Worldwide total number of subjects
    385
    EEA total number of subjects
    385
    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)
    216
    From 65 to 84 years
    169
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 GETUG 15 is a A multicentre, randomized, open-label phase III study was designed to evaluate the efficacy and safety of docetaxel combined with hormone therapy compared to hormone therapy alone in HSMPC. 385 patients were included form 18-Oct-2004 to 31-Dec-2008.

    Pre-assignment
    Screening details
    		 The study consisted of a screening phase of up to 30 days before treatment initiation to establish eligibility and document baseline measurements, a treatment phase (21-day cycle), and a long-term follow-up to monitor overall survival, clinical progression, quality of life, and safety.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Docetaxel plus hormone therapy
    Arm description
    		 Patients were randomly allocated to receive Docetaxel once every 3 weeks until disease progression for a maximum of 9 cycles (1 cycle = 3 weeks). The following hormone therapies were allowed during the study either: * LHRH agonist (Zoladex®) * Surgical castration * Complete androgen blockage (CAB): combination of LHRH agonist (Zoladex®) and peripheral antiandrogen (Anandron®). The hormone therapy started less than 2 months before docetaxel treatment initiation. The hormone treatment and docetaxel treatment could have been initiated at the same time. The hormone treatment was continued until androgen resistance.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    75 mg/m²/day on day 1 of every 3 week cycle until disease progression for a maximum of 9 cycles

    Investigational medicinal product name
    Goserelin
    Investigational medicinal product code
    Other name
    Zoladex
    Pharmaceutical forms
    Implant in pre-filled syringe
    Routes of administration
    Implantation
    Dosage and administration details
    3.6 mg implant goserelin started less than 2 months before Docetaxel treatment. The Goserelin and docetaxel could have been initiated at the same time. The goserelin treatment was continued until androgen resistance.

    Investigational medicinal product name
    Nilutamide
    Investigational medicinal product code
    Other name
    Anandron
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients swallowed 2 tablets of 150 mg nilutalide per day during 4 weeks, then 1 tablet daily day therafter. When prescribed, nilutalide was administrated in combination with goserelin. Nilutamide treatment started less than 2 months before docetaxel treatment. The Nilutamide treatment and docetaxel treatment could have been initiated at the same time. The Nilutamide treatment was continued until androgen resistance.

    Arm title
    		 Hormone therapy
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Goserelin
    Investigational medicinal product code
    Other name
    Zoladex
    Pharmaceutical forms
    Implant in pre-filled syringe
    Routes of administration
    Implantation
    Dosage and administration details
    3.6 mg implant goserelin started less than 2 months before Docetaxel treatment. The goserelin treatment was continued until androgen resistance.

    Investigational medicinal product name
    Nilutamide
    Investigational medicinal product code
    Other name
    Anandron
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients swallowed 2 tablets of 150 mg nilutalide per day during 4 weeks, then 1 tablet daily day therafter. When prescribed, nilutalide was administrated in combination with goserelin. The Nilutamide treatment was continued until androgen resistance.

    Number of subjects in period 1
    		Docetaxel plus hormone therapy Hormone therapy
    Started
    192
    193
    Completed
    104
    105
    Not completed
    88
    88
         Death
    88
    88

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Docetaxel plus hormone therapy
    Reporting group description
    		 Patients were randomly allocated to receive Docetaxel once every 3 weeks until disease progression for a maximum of 9 cycles (1 cycle = 3 weeks). The following hormone therapies were allowed during the study either: * LHRH agonist (Zoladex®) * Surgical castration * Complete androgen blockage (CAB): combination of LHRH agonist (Zoladex®) and peripheral antiandrogen (Anandron®). The hormone therapy started less than 2 months before docetaxel treatment initiation. The hormone treatment and docetaxel treatment could have been initiated at the same time. The hormone treatment was continued until androgen resistance.

    Reporting group title
    Hormone therapy
    Reporting group description
    		 -

    Reporting group values
    		 Docetaxel plus hormone therapy Hormone therapy Total
    Number of subjects
    		 192 193 385
    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)
    		 113 103 216
        From 65-84 years
    		 79 90 169
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 63 (46 to 79) 64 (43 to 84) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 192 193 385
    Gleason score
    Units: Subjects
        2-6
    		 19 15 34
        7.
    		 67 64 131
        8-10
    		 106 114 220
    Treatment for local disease
    Units: Subjects
        Prostatectomy
    		 33 25 58
        Radiotherapy
    		 36 33 69
        ADT
    		 19 15 34
        CHemotherapy
    		 2 0 2
        None
    		 102 120 222
    Metastatic at diagnosis
    Units: Subjects
        Yes
    		 129 147 276
        No
    		 63 46 109
    Prognostic group
    Units: Subjects
        Good
    		 95 96 191
        Intermediate
    		 54 57 111
        Poor
    		 43 40 83
    Karnofsky index
    Units: Percentage
        median (full range (min-max))
    		 100 (70 to 100) 100 (60 to 100) -
    PSA level
    Units: mg/ml
        median (full range (min-max))
    		 26.7 (0.05 to 2170) 25.85 (0.1 to 11900) -

    End points

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    End points reporting groups
    Reporting group title
    Docetaxel plus hormone therapy
    Reporting group description
    		 Patients were randomly allocated to receive Docetaxel once every 3 weeks until disease progression for a maximum of 9 cycles (1 cycle = 3 weeks). The following hormone therapies were allowed during the study either: * LHRH agonist (Zoladex®) * Surgical castration * Complete androgen blockage (CAB): combination of LHRH agonist (Zoladex®) and peripheral antiandrogen (Anandron®). The hormone therapy started less than 2 months before docetaxel treatment initiation. The hormone treatment and docetaxel treatment could have been initiated at the same time. The hormone treatment was continued until androgen resistance.

    Reporting group title
    Hormone therapy
    Reporting group description
    		 -

    Primary: 3-year Overall survival

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    End point title
    		 3-year Overall survival
    End point description
    The principal objective was to compare the benefit on overall survival at 36 months of docetaxel + androgen blockade at the first metastatic phase versus androgen blockade only.
    End point type
    Primary
    End point timeframe
    Overall survival was defined as the number of patients being alive at least 36 months after randomization.
    End point values
    		 Docetaxel plus hormone therapy Hormone therapy
    Number of subjects analysed
    192
    193
    Units: Percent of patients
        median (confidence interval 95%)
    64.2 (57.5 to 71.6)
    62.9 (56.3 to 70.3)
    Statistical analysis title
    		 3-year overall survival
    Comparison groups
    Hormone therapy v Docetaxel plus hormone therapy
    Number of subjects included in analysis
    385
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.955
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.36

    Secondary: Clinical progression free survival

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    End point title
    		 Clinical progression free survival
    End point description
    The date of clinical progression was defined as the date of the first investigation (bone scintigraphy, pelvic scan or MRI, etc.) to show clinical progression. In the absence PSA level increase, clinical progression on scintigraphy was considered when one or several new lesions appeared. In patients with measurable lesions, clinical progression was defined using RECIST 1.0. In patients with bone lesions only, disease progression was defined as the appearance of one or more new bone lesions on bone scan.
    End point type
    Secondary
    End point timeframe
    Tumor assessments were performed at baseline and every 3 months for the first 3.5 years then every 6 months until disease progression.
    End point values
    		 Docetaxel plus hormone therapy Hormone therapy
    Number of subjects analysed
    192
    193
    Units: Percent of patients
        median (confidence interval 95%)
    23.5 (20.5 to 31.9)
    15.4 (12.5 to 19.8)
    Statistical analysis title
    		 Clinical progression free survival
    Comparison groups
    Docetaxel plus hormone therapy v Hormone therapy
    Number of subjects included in analysis
    385
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.015
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 0.94

    Secondary: biological/laboratory progression free survival

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    End point title
    		 biological/laboratory progression free survival
    End point description
    The biological/laboratory progression was evaluated using two definitions: Using the Prostate Working Group 1 definition: * For subjects without a decrease in PSA levels, or with a decrease in PSA levels of <50%, progression was defined as a 25% increase from the nadir with a minimum increase in absolute value of 5 ng/mL. A progression was confirmed by a second sample. * For subjects who had a response in PSA levels of >50% confirmed by a second sample 1 month later, progression was defined as an increase of >50% in relation to the nadir with a minimum increase in absolute value of 5 ng/mL. A progression was confirmed by a second sample. Using the recommendations of the Prostate Working Group 2: Increase in the PSA level of 25% with respect to nadir and with an absolute increase of ≥2 ng/mL: * After 12 weeks for the patients whose PSA levels did not decrease or decreased <50%. * For patients whose PSA levels decrease ≥50%.
    End point type
    Secondary
    End point timeframe
    The survival without biological/laboratory progression was calculated from date of randomization until the date of biological/laboratory progression, or death of any cause.
    End point values
    		 Docetaxel plus hormone therapy Hormone therapy
    Number of subjects analysed
    192
    193
    Units: Months
        median (confidence interval 95%)
    22.4 (17.4 to 25.9)
    12.4 (9.9 to 15.1)
    Statistical analysis title
    		 Biological/laboratory progression-free survival
    Comparison groups
    Docetaxel plus hormone therapy v Hormone therapy
    Number of subjects included in analysis
    385
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 0.88

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomization until 30 days after end of treatment (up to 6 years).
    Adverse event reporting additional description
    For non-serious adverse events, the number of occurrences were not recorded, the number of patient affected were the only value available. Thus, the number of patient affected was entered in both "Subjects affected number" and "Occurrence all number" fields.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8
    Reporting groups
    Reporting group title
    Docetaxel plus hormone therapy
    Reporting group description
    		 Patients were randomly allocated to receive Docetaxel once every 3 weeks until disease progression for a maximum of 9 cycles (1 cycle = 3 weeks). The following hormone therapies were allowed during the study either: * LHRH agonist (Zoladex®) * Surgical castration * Complete androgen blockage (CAB): combination of LHRH agonist (Zoladex®) and peripheral antiandrogen (Anandron®). The hormone therapy started less than 2 months before docetaxel treatment initiation. The hormone treatment and docetaxel treatment could have been initiated at the same time. The hormone treatment was continued until androgen resistance.

    Reporting group title
    Hormone therapy
    Reporting group description
    		 -

    Serious adverse events
    		 Docetaxel plus hormone therapy Hormone therapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    76 / 189 (40.21%)
    33 / 186 (17.74%)
         number of deaths (all causes)
    88
    88
         number of deaths resulting from adverse events
    4
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of prostate
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Basal cell epithelioma
         subjects affected / exposed
    0 / 189 (0.00%)
    2 / 186 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intraductal papillary mucinous neoplasm
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung carcinoma
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid cancer stage unspecified
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer metastatic
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Arterial insufficiency periferal
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Claudication intermittent
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stroke
         subjects affected / exposed
    3 / 189 (1.59%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis arterial leg
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis in device
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hip arthroplasty
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone operation
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrectomy
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rehabilitation therapy
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal polypectomy
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal decompression
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent placement
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroidectomy
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral repair
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Catheter site infection
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General discomfort
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    7 / 189 (3.70%)
    2 / 186 (1.08%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Injection site infection
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucositis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenocarcinoma lung
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exacerbated
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia interstitial
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic pain
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 189 (0.00%)
    2 / 186 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Catheter sepsis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compression fracture vertebra
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis injection site
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac insufficiency
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain retrosternal
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic pain
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac discomfort
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 189 (0.00%)
    2 / 186 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Nervous system disorders
    Bleeding intracranial
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cauda equina syndrome
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma non diabetic
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusion
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epiduritis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy NOS
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vagal reaction
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile aplasia
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    6 / 189 (3.17%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    6 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    25 / 189 (13.23%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    39 / 39
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Gastrointestinal disorders
    Abdominal pain localised
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction NOS
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatitis
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis perforative
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis toxic
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin cancer
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis NOS
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis aggravated
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (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
    Dysuria
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    2 / 189 (1.06%)
    2 / 186 (1.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macroscopic haematuria
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal insufficiency
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary obstruction unspecified
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Diabetes mellitus insulin-dependent
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Lumbar pain
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in spine
         subjects affected / exposed
    0 / 189 (0.00%)
    2 / 186 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain lower ribs
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (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
    Septic shock
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enzyme abnormality
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Docetaxel plus hormone therapy Hormone therapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    189 / 189 (100.00%)
    186 / 186 (100.00%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    140 / 189 (74.07%)
    37 / 186 (19.89%)
         occurrences all number
    140
    37
    Fever (in the abscence of neutropenia)
         subjects affected / exposed
    20 / 189 (10.58%)
    1 / 186 (0.54%)
         occurrences all number
    20
    1
    Gain or loss of weight
         subjects affected / exposed
    38 / 189 (20.11%)
    21 / 186 (11.29%)
         occurrences all number
    38
    21
    Hot flashes
         subjects affected / exposed
    70 / 189 (37.04%)
    118 / 186 (63.44%)
         occurrences all number
    70
    118
    Pain
         subjects affected / exposed
    32 / 189 (16.93%)
    26 / 186 (13.98%)
         occurrences all number
    32
    26
    Reproductive system and breast disorders
    Urinary tract infection
         subjects affected / exposed
    21 / 189 (11.11%)
    23 / 186 (12.37%)
         occurrences all number
    21
    23
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    36 / 189 (19.05%)
    3 / 186 (1.61%)
         occurrences all number
    36
    3
    Cough
         subjects affected / exposed
    26 / 189 (13.76%)
    2 / 186 (1.08%)
         occurrences all number
    26
    2
    Psychiatric disorders
    Libido decreased
         subjects affected / exposed
    21 / 189 (11.11%)
    28 / 186 (15.05%)
         occurrences all number
    21
    28
    Cardiac disorders
    Oedema
         subjects affected / exposed
    55 / 189 (29.10%)
    10 / 186 (5.38%)
         occurrences all number
    55
    10
    Nervous system disorders
    Sensory neuropathy
         subjects affected / exposed
    54 / 189 (28.57%)
    7 / 186 (3.76%)
         occurrences all number
    54
    7
    Insomnia
         subjects affected / exposed
    16 / 189 (8.47%)
    8 / 186 (4.30%)
         occurrences all number
    16
    8
    Blood and lymphatic system disorders
    Haemoglobin
         subjects affected / exposed
    136 / 189 (71.96%)
    41 / 186 (22.04%)
         occurrences all number
    136
    41
    Neutrophils/granulocytes
         subjects affected / exposed
    94 / 189 (49.74%)
    5 / 186 (2.69%)
         occurrences all number
    94
    5
    Platelet
         subjects affected / exposed
    20 / 189 (10.58%)
    9 / 186 (4.84%)
         occurrences all number
    20
    9
    Gastrointestinal disorders
    Anorexia
         subjects affected / exposed
    14 / 189 (7.41%)
    1 / 186 (0.54%)
         occurrences all number
    14
    1
    Constipation
         subjects affected / exposed
    42 / 189 (22.22%)
    9 / 186 (4.84%)
         occurrences all number
    42
    9
    Diarrhoea
         subjects affected / exposed
    58 / 189 (30.69%)
    4 / 186 (2.15%)
         occurrences all number
    58
    4
    Nausea
         subjects affected / exposed
    55 / 189 (29.10%)
    4 / 186 (2.15%)
         occurrences all number
    55
    4
    Stomatitis/pharyngitis
         subjects affected / exposed
    15 / 189 (7.94%)
    0 / 186 (0.00%)
         occurrences all number
    15
    0
    Vomiting
         subjects affected / exposed
    16 / 189 (8.47%)
    0 / 186 (0.00%)
         occurrences all number
    16
    0
    Mucositis
         subjects affected / exposed
    40 / 189 (21.16%)
    0 / 186 (0.00%)
         occurrences all number
    40
    0
    Hepatobiliary disorders
    Alkaline phosphatase
         subjects affected / exposed
    52 / 189 (27.51%)
    40 / 186 (21.51%)
         occurrences all number
    52
    40
    Alanine aminotransferase
         subjects affected / exposed
    43 / 189 (22.75%)
    22 / 186 (11.83%)
         occurrences all number
    43
    22
    Aspartate aminotransferase
         subjects affected / exposed
    38 / 189 (20.11%)
    17 / 186 (9.14%)
         occurrences all number
    38
    17
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    102 / 189 (53.97%)
    1 / 186 (0.54%)
         occurrences all number
    102
    1
    Rash/desquamation
         subjects affected / exposed
    29 / 189 (15.34%)
    3 / 186 (1.61%)
         occurrences all number
    29
    3
    Skin reaction/hands-feet
         subjects affected / exposed
    27 / 189 (14.29%)
    1 / 186 (0.54%)
         occurrences all number
    27
    1
    Nail alert
         subjects affected / exposed
    74 / 189 (39.15%)
    0 / 186 (0.00%)
         occurrences all number
    74
    0
    Renal and urinary disorders
    Creatinine
         subjects affected / exposed
    21 / 189 (11.11%)
    14 / 186 (7.53%)
         occurrences all number
    21
    14
    Nycturia
         subjects affected / exposed
    23 / 189 (12.17%)
    17 / 186 (9.14%)
         occurrences all number
    23
    17
    Endocrine disorders
    Gynecomastia
         subjects affected / exposed
    8 / 189 (4.23%)
    10 / 186 (5.38%)
         occurrences all number
    8
    10
    Infections and infestations
    Febrile neutropenia
         subjects affected / exposed
    15 / 189 (7.94%)
    0 / 186 (0.00%)
         occurrences all number
    15
    0
    Infection without neutropenia
         subjects affected / exposed
    25 / 189 (13.23%)
    3 / 186 (1.61%)
         occurrences all number
    25
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Sep 2004
    The chemotherapy used in the study for Arm A was changed from docetaxel with estramustine to only docetaxel.
    12 Oct 2005
    G-CSF was administrated to patients in the experimental arm to prevent docetaxel-induced severe neutropenia. Following an increase in the frequency of thromboembolic events and abnormal death rates in other studies evaluating the use of growth factors in cancer patients. The French Competent authority and the EMEA demanded that the protocol and patient’s information sheet be modified to take into account the new administration rules for Aranesp®.
    06 Jul 2007
    Following an IDMC and after the accrual of 215 subjects, 2 treatment-related deaths were reported in Arm A, due to neutropenic fever and pulmonary embolism. The independent data monitoring committee recommended the systematic administration of granulocytes colony-stimulating factors (G-CSF) from day 5 to day 10 at each docetaxel cycle.

    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 investigators underestimated OS in the ADT group and overestimated potential difference in term of survival for the sample size calculation. Thus the study did not have sufficient power to show a small difference in OS.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/23306100
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