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    Clinical Trial Results:
    Phase II multicenter study to analyze the predictive value of fusion gene TMPRSS2-ETS in response to enzalutamide in patients with metastatic CRPC no previously treated with chemotherapy

    Summary
    EudraCT number
    		 2014-003192-28
    Trial protocol
    		 ES  
    Global end of trial date
    18 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2020
    First version publication date
    27 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SOG-MIE-2014-04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02288936
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Spanish Oncology Genito-Urinary Group
    Sponsor organisation address
    Velázquez, 7, 3rd floor, Madrid, Spain, 28001
    Public contact
    Spanish Oncology Genito-Urinary Group, SOGUG, 0034 610286915,
    Scientific contact
    Spanish Oncology Genito-Urinary Group, SOGUG, 0034 610286915,
    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
    21 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    PSA progression free survival (PCWG2 criteria) depending on the presence of TMPRSS2-ETS fusion gene rearrangements
    Protection of trial subjects
    All patients have been treated according to GCP criteria. Patients were entitled to withdraw from the study at any time and for any reason without prejudice of their future medical care on the part of the doctor or the center. Any medication that patients needed for their correct clinical control (except prohibited therapies), according to investigator’s criteria were allowed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jan 2015
    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: 98
    Worldwide total number of subjects
    98
    EEA total number of subjects
    98
    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)
    9
    From 65 to 84 years
    80
    85 years and over
    9

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients initiated enzalutamide as first line treatment between February and November 2015 at 16 Spanish institutions

    Pre-assignment
    Screening details
    		 Patients had to sign an informed consent for biomarkers study. A physical examination, serology, hematology, biochemistry, ECG and a tumor evaluation and biopsy were performed to participating patients.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Study treatment
    Arm description
    		 Treatment with enzalutamide 160 mg/day until progression disease, unacceptable toxicity, protocol non-compliance or withdrawal of consent.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Enzalutamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Enzalutamida dose will be 160 mg/day (Four capsules of 40 mg each)

    Number of subjects in period 1
    		Study treatment
    Started
    98
    Completed
    98

    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
    		 98 98
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 9 9
        From 65-84 years
    		 80 80
        85 years and over
    		 9 9
    Age continuous
    Units: years
        median (full range (min-max))
    		 77 (57 to 95) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 98 98
    Bone metastases
    Units: Subjects
        Yes
    		 80 80
        No
    		 18 18
    Number of bone metastases
    Units: Subjects
        <4
    		 50 50
        >=4
    		 30 30
        No
    		 18 18
    ECOG
    Units: Subjects
        ECOG-0
    		 53 53
        ECOG-1
    		 45 45
    Pain
    Units: Subjects
        No pain
    		 45 45
        Mild (<= BPI score
    		 52 52
        NA
    		 1 1
    CTC status
    Units: Subjects
        Positive
    		 35 35
        Negative
    		 63 63
    AR status
    Units: Subjects
        Gain
    		 11 11
        Without changes
    		 87 87
    ALP ratio
    Units: Subjects
        high
    		 28 28
        Normal values
    		 70 70
    LDH ratio
    Units: Subjects
        High
    		 31 31
        Normal ranges
    		 67 67
    TMPRSS-ERG-RT_PCR
    Units: Subjects
        Negative
    		 66 66
        Positive
    		 32 32
    ERG - IHC
    Units: Subjects
        Negative
    		 63 63
        Positive
    		 35 35
    Visceral metastases
    Units: Subjects
        Yes
    		 17 17
        No
    		 81 81
    Liver metastases
    Units: Subjects
        Yes
    		 4 4
        No
    		 94 94
    Lymph nodes metastases
    Units: Subjects
        Yes
    		 47 47
        No
    		 51 51
    PSA
    Units: ng/dL
        median (full range (min-max))
    		 24.95 (0.59 to 4319) -
    Albumin
    Units: ug/dL
        median (full range (min-max))
    		 4.15 (3.29 to 5.00) -
    Haemoglobin
    Units: g/dL
        median (full range (min-max))
    		 13.2 (7.5 to 17.3) -
    ALP ratio
    Units: Not applicable
        median (full range (min-max))
    		 0.71 (0.24 to 17.46) -
    LDH ratio
    Units: Not applicable
        median (full range (min-max))
    		 0.84 (0.29 to 3.36) -
    Neutrophil to lymphocyte ratio
    Units: Not applicable
        median (full range (min-max))
    		 2.14 (0.52 to 12.33) -
    Plasma DNA
    Units: ng/mL
        median (full range (min-max))
    		 18.64 (0.00 to 1585.00) -
    Subject analysis sets

    Subject analysis set title
    TMPRSS2-ERG Negative
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with TMPRSS2-ERG gen negative

    Subject analysis set title
    TMPRSS2-ERG Positive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with TMPRSS2-ERG gen positive

    Subject analysis sets values
    		 TMPRSS2-ERG Negative TMPRSS2-ERG Positive
    Number of subjects
    66
    32
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    5
    4
        From 65-84 years
    57
    23
        85 years and over
    4
    5
    Age continuous
    Units: years
        median (full range (min-max))
    76 (57 to 87)
    80 (60 to 95)
    Gender categorical
    Units: Subjects
        Female
    0
    0
        Male
    66
    32
    Bone metastases
    Units: Subjects
        Yes
    53
    27
        No
    13
    5
    Number of bone metastases
    Units: Subjects
        <4
    34
    16
        >=4
    19
    11
        No
    13
    5
    ECOG
    Units: Subjects
        ECOG-0
    32
    21
        ECOG-1
    34
    11
    Pain
    Units: Subjects
        No pain
    30
    15
        Mild (<= BPI score
    35
    17
        NA
    1
    0
    CTC status
    Units: Subjects
        Positive
    23
    12
        Negative
    43
    20
    AR status
    Units: Subjects
        Gain
    5
    6
        Without changes
    61
    26
    ALP ratio
    Units: Subjects
        high
    16
    12
        Normal values
    40
    20
    LDH ratio
    Units: Subjects
        High
    21
    10
        Normal ranges
    45
    22
    TMPRSS-ERG-RT_PCR
    Units: Subjects
        Negative
        Positive
    ERG - IHC
    Units: Subjects
        Negative
        Positive
    Visceral metastases
    Units: Subjects
        Yes
    12
    5
        No
    54
    27
    Liver metastases
    Units: Subjects
        Yes
    3
    1
        No
    63
    31
    Lymph nodes metastases
    Units: Subjects
        Yes
    28
    19
        No
    38
    13
    PSA
    Units: ng/dL
        median (full range (min-max))
    24.36 (2.5 to 4318.78)
    29.53 (0.59 to 870.58)
    Albumin
    Units: ug/dL
        median (full range (min-max))
    4.11 (3.29 to 5.00)
    4.18 (3.50 to 4.90)
    Haemoglobin
    Units: g/dL
        median (full range (min-max))
    13.15 (7.50 to 16.40)
    13.35 (9.10 to 17.30)
    ALP ratio
    Units: Not applicable
        median (full range (min-max))
    0.70 (0.24 to 11.85)
    0.77 (0.31 to 17.46)
    LDH ratio
    Units: Not applicable
        median (full range (min-max))
    0.84 (0.29 to 3.36)
    0.84 (0.61 to 2.51)
    Neutrophil to lymphocyte ratio
    Units: Not applicable
        median (full range (min-max))
    2.10 (0.52 to 6.17)
    2.33 (0.61 to 12.33)
    Plasma DNA
    Units: ng/mL
        median (full range (min-max))
    17.84 (0.06 to 1585.00)
    20.44 (0.5 to 164.09)

    End points

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    End points reporting groups
    Reporting group title
    Study treatment
    Reporting group description
    		 Treatment with enzalutamide 160 mg/day until progression disease, unacceptable toxicity, protocol non-compliance or withdrawal of consent.

    Subject analysis set title
    TMPRSS2-ERG Negative
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with TMPRSS2-ERG gen negative

    Subject analysis set title
    TMPRSS2-ERG Positive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with TMPRSS2-ERG gen positive

    Primary: PSA progression free survival

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    End point title
    		 PSA progression free survival
    End point description
    End point type
    Primary
    End point timeframe
    Time from study entry to an increase of >= 25% or an absolute increase >= 2ng/mL
    End point values
    		 Study treatment TMPRSS2-ERG Negative TMPRSS2-ERG Positive
    Number of subjects analysed
    98
    66
    32
    Units: months
        median (confidence interval 95%)
    14.1 (10.2 to 20.2)
    14.7 (10.68 to 20.5)
    12.8 (7.36 to 20.5)
    Statistical analysis title
    		 PSA progression free survival
    Comparison groups
    TMPRSS2-ERG Negative v TMPRSS2-ERG Positive
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.8
    Method
    		 Fisher exact
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 1.58

    Secondary: PSA response rate

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    End point title
    		 PSA response rate
    End point description
    End point type
    Secondary
    End point timeframe
    From patient inclusion to the lowest result of PSA subsequent basal status.
    End point values
    		 Study treatment TMPRSS2-ERG Negative TMPRSS2-ERG Positive
    Number of subjects analysed
    98
    66
    30
    Units: Patients
        Decline >= 50%
    79
    55
    24
        Decline < 50%
    19
    11
    6
    Statistical analysis title
    		 PSA response rate
    Comparison groups
    TMPRSS2-ERG Negative v TMPRSS2-ERG Positive
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.69
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Radiographic response rate

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    End point title
    		 Radiographic response rate
    End point description
    End point type
    Secondary
    End point timeframe
    From patient start to the lowest PSA level subsequent basal status.
    End point values
    		 Study treatment TMPRSS2-ERG Negative TMPRSS2-ERG Positive
    Number of subjects analysed
    43
    30
    13
    Units: Patients
        Objective response
    21
    14
    7
        Stable disease
    17
    13
    4
        Progressive disease
    5
    2
    2
    Statistical analysis title
    		 Radiographic response
    Comparison groups
    TMPRSS2-ERG Negative v TMPRSS2-ERG Positive
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.5
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Radiographic progression free survival

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    End point title
    		 Radiographic progression free survival
    End point description
    End point type
    Secondary
    End point timeframe
    Time from study entry to radiographic progression
    End point values
    		 Study treatment TMPRSS2-ERG Negative TMPRSS2-ERG Positive
    Number of subjects analysed
    98
    66
    32
    Units: months
        median (confidence interval 95%)
    25.2 (21.7 to 33.1)
    23.9 (20.3 to 24.0)
    27.9 (17.9 to 30.0)
    Statistical analysis title
    		 Radiographic progression free survival
    Comparison groups
    TMPRSS2-ERG Negative v TMPRSS2-ERG Positive
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.857
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 1.96

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    From study entry to patient exitus.
    End point values
    		 Study treatment TMPRSS2-ERG Negative TMPRSS2-ERG Positive
    Number of subjects analysed
    98
    66
    32
    Units: months
        median (confidence interval 95%)
    37.5 (33.7 to 39.0)
    38.1 (33.7 to 39.0)
    36.9 (27.6 to 37.3)
    Statistical analysis title
    		 Overall Survival
    Comparison groups
    TMPRSS2-ERG Negative v TMPRSS2-ERG Positive
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.4873
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 2.21

    Secondary: PSA rate >=90%

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    End point title
    		 PSA rate >=90%
    End point description
    End point type
    Secondary
    End point timeframe
    From patient inclusion to the lowest result of PSA subsequent basal status
    End point values
    		 Study treatment TMPRSS2-ERG Negative TMPRSS2-ERG Positive
    Number of subjects analysed
    98
    66
    30
    Units: Patients
        Decline >=90%
    51
    36
    15
        Decline < 90%
    47
    30
    15
    Statistical analysis title
    		 PSA decline >=90%
    Comparison groups
    TMPRSS2-ERG Negative v TMPRSS2-ERG Positive
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.83
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From patient informed consent signature to last dose of study treatment
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    35 / 98 (35.71%)
         number of deaths (all causes)
    50
         number of deaths resulting from adverse events
    2
    Vascular disorders
    Ischemic stroke
         subjects affected / exposed
    4 / 98 (4.08%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cognitive disorder
         subjects affected / exposed
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    6 / 98 (6.12%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    5 / 98 (5.10%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Back pain
         subjects affected / exposed
    3 / 98 (3.06%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Fracture
         subjects affected / exposed
    4 / 98 (4.08%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    98 / 98 (100.00%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 98 (2.04%)
         occurrences all number
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    37 / 98 (37.76%)
         occurrences all number
    37
    Flushing
         subjects affected / exposed
    23 / 98 (23.47%)
         occurrences all number
    23
    Peripheral swelling
         subjects affected / exposed
    19 / 98 (19.39%)
         occurrences all number
    19
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    6 / 98 (6.12%)
         occurrences all number
    6
    Cardiac failure
         subjects affected / exposed
    4 / 98 (4.08%)
         occurrences all number
    4
    Atrioventricular block
         subjects affected / exposed
    1 / 98 (1.02%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 98 (10.20%)
         occurrences all number
    10
    Cognitive disorder
         subjects affected / exposed
    5 / 98 (5.10%)
         occurrences all number
    5
    Spinal cord compression
         subjects affected / exposed
    2 / 98 (2.04%)
         occurrences all number
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    70 / 98 (71.43%)
         occurrences all number
    70
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    16 / 98 (16.33%)
         occurrences all number
    16
    Constipation
         subjects affected / exposed
    15 / 98 (15.31%)
         occurrences all number
    15
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    3 / 98 (3.06%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    38 / 98 (38.78%)
         occurrences all number
    38
    Back pain
         subjects affected / exposed
    23 / 98 (23.47%)
         occurrences all number
    23
    Fracture
         subjects affected / exposed
    6 / 98 (6.12%)
         occurrences all number
    6
    Metabolism and nutrition disorders
    Anorexia nervosa
         subjects affected / exposed
    23 / 98 (23.47%)
         occurrences all number
    23
    Hepatic enzyme increased
         subjects affected / exposed
    5 / 98 (5.10%)
         occurrences all number
    5
    Weight decreased
         subjects affected / exposed
    2 / 98 (2.04%)
         occurrences all number
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Dec 2018
    Recruitment period increased.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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