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    Clinical Trial Results:
    Toxicity of first-line abiraterone versus enzalutamide in men with metastatic castration-resistant prostate cancer: A randomized clinical trial

    Summary
    EudraCT number
    		 2017-000099-27
    Trial protocol
    		 DK  
    Global end of trial date
    06 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Oct 2022
    First version publication date
    27 Oct 2022
    Other versions
    Summary report(s)
    		 Summary attachment

    Trial information

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    Trial identification
    Sponsor protocol code
    HEAT01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev and Gentofte Hospital
    Sponsor organisation address
    Borgmester Ib Juulsvej 1, Herlev, Denmark, 2730
    Public contact
    The Department of Urology, The Department of Urology, 38686349 38689927, klara.kvorning.ternov@regionh.dk
    Scientific contact
    The Department of Urology, The Department of Urology, 38686349 38689927, klara.kvorning.ternov@regionh.dk
    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
    06 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this project is to investigate if there is a group-difference in treatment related adverse effects between abiraterone and enzalutamide in regards to: • Fatigue • Metabolic profile • Health related quality of life (HQoL) The aim of preforming the above is to generate knowledge in order to enable a more individualized treatment of patients with mCRPC, based on the therapies profile of adverse effects and the patients’ individual needs.
    Protection of trial subjects
    Informed consent and measurement of adverse events, HRQoL and fatigue
    Background therapy
    		 Androgen deprivation therapy
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jun 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 169
    Worldwide total number of subjects
    169
    EEA total number of subjects
    169
    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)
    15
    From 65 to 84 years
    133
    85 years and over
    21

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 2nd June 2017 and 27th September 2019, 170 patients were randomly assigned to enzalutamide (n Z 84) or AAP (n Z 85)

    Pre-assignment
    Screening details
    		 Eligible patients had metastatic prostate cancer and disease progression on ADT (testosterone 1.7 nmol/L), as per the Prostate Cancer Working Group 3 criteria. Exclusion criteria included diabetes mellitus, visceral metastases, docetaxel in the hormone-naıve setting, other malignacies and heart failure.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    None

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 enzalutamide
    Arm description
    		 enzalutamide
    Arm type
    		 Active comparator

    Investigational medicinal product name
    enzalutamide
    Investigational medicinal product code
    Other name
    Xtandi
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg/day orally

    Arm title
    		 abiraterone
    Arm description
    		 Abiraterone acetate 1000mg + 10 mg prednisone
    Arm type
    		 Active comparator

    Investigational medicinal product name
    abiraterone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    abiraterone acetate tablets (1000 mg/day orally either 1 h before or 2 h after the intake of food) in the evening combined with prednisone tablets (10 mg/day orally) in the morning.

    Number of subjects in period 1
    		enzalutamide abiraterone
    Started
    84
    85
    Completed
    84
    85

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Reporting group values
    		 Overall Total
    Number of subjects
    		 169 169
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 75 (51 to 88) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 169 169

    End points

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    End points reporting groups
    Reporting group title
    enzalutamide
    Reporting group description
    		 enzalutamide

    Reporting group title
    abiraterone
    Reporting group description
    		 Abiraterone acetate 1000mg + 10 mg prednisone

    Primary: Between-group differences in changed level of fatigue assessed with the questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

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    End point title
    		 Between-group differences in changed level of fatigue assessed with the questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
    End point description
    End point type
    Primary
    End point timeframe
    mean change from baseline to 12-week follow-up
    End point values
    		 enzalutamide abiraterone
    Number of subjects analysed
    84
    85
    Units: FACIT-Fatigue points
        arithmetic mean (confidence interval 95%)
    -2.3 (-3.9 to -0.7)
    0.9 (-0.8 to 2.6)
    Statistical analysis title
    		 mixed effect models
    Statistical analysis description
    The between-group differences in changed outcomes were analysed with linear mixed effect models constrained longitudinal analysis
    Comparison groups
    enzalutamide v abiraterone
    Number of subjects included in analysis
    169
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 > 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 5.6
    Notes
    [1] - The between-group differences in changed outcomes were analysed with linear mixed effect models constrained longitudinal analysis

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Side effects are monitored at the three-month follow-up visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    enzalutamide
    Reporting group description
    		 enzalutamide

    Reporting group title
    abiraterone
    Reporting group description
    		 Abiraterone acetate 1000mg + 10 mg prednisone

    Serious adverse events
    		 enzalutamide abiraterone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 84 (8.33%)
    7 / 85 (8.24%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Investigations
    CPK increased
    Additional description: Rhabdomyolysis
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Vascular disorders - Other, specify
    Additional description: life-threatening bleeding from a varices
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Esophagitis
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary tract obstruction
         subjects affected / exposed
    2 / 84 (2.38%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 84 (2.38%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone infection
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    2 / 84 (2.38%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalemia
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (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: 0.05%
    Non-serious adverse events
    		 enzalutamide abiraterone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    77 / 84 (91.67%)
    77 / 85 (90.59%)
    Investigations
    Weight loss
         subjects affected / exposed
    9 / 84 (10.71%)
    4 / 85 (4.71%)
         occurrences all number
    9
    4
    Investigations - Other, specify
    Additional description: Increased liver enzymes
         subjects affected / exposed
    2 / 84 (2.38%)
    23 / 85 (27.06%)
         occurrences all number
    2
    23
    Creatinine increased
         subjects affected / exposed
    1 / 84 (1.19%)
    5 / 85 (5.88%)
         occurrences all number
    1
    5
    Vascular disorders
    Hot flashes
         subjects affected / exposed
    16 / 84 (19.05%)
    13 / 85 (15.29%)
         occurrences all number
    16
    13
    Hypertension
         subjects affected / exposed
    18 / 84 (21.43%)
    14 / 85 (16.47%)
         occurrences all number
    18
    14
    Nervous system disorders
    Nervous system disorders - Other, specify
    Additional description: Restless legs syndrome
         subjects affected / exposed
    15 / 84 (17.86%)
    8 / 85 (9.41%)
         occurrences all number
    15
    8
    Headache
         subjects affected / exposed
    7 / 84 (8.33%)
    1 / 85 (1.18%)
         occurrences all number
    7
    1
    Amnesia
         subjects affected / exposed
    7 / 84 (8.33%)
    0 / 85 (0.00%)
         occurrences all number
    7
    0
    Dizziness
         subjects affected / exposed
    14 / 84 (16.67%)
    3 / 85 (3.53%)
         occurrences all number
    14
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    35 / 84 (41.67%)
    20 / 85 (23.53%)
         occurrences all number
    35
    20
    Edema limbs
         subjects affected / exposed
    6 / 84 (7.14%)
    3 / 85 (3.53%)
         occurrences all number
    6
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 84 (3.57%)
    4 / 85 (4.71%)
         occurrences all number
    3
    4
    Constipation
         subjects affected / exposed
    5 / 84 (5.95%)
    8 / 85 (9.41%)
         occurrences all number
    5
    8
    Diarrhea
         subjects affected / exposed
    4 / 84 (4.76%)
    0 / 85 (0.00%)
         occurrences all number
    4
    0
    Dyspepsia
         subjects affected / exposed
    2 / 84 (2.38%)
    9 / 85 (10.59%)
         occurrences all number
    2
    9
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    0 / 84 (0.00%)
    4 / 85 (4.71%)
         occurrences all number
    0
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 84 (4.76%)
    2 / 85 (2.35%)
         occurrences all number
    4
    2
    Renal and urinary disorders
    Urinary tract obstruction
         subjects affected / exposed
    3 / 84 (3.57%)
    6 / 85 (7.06%)
         occurrences all number
    3
    6
    Endocrine disorders
    Endocrine disorders - Other, specify
    Additional description: Diabetes Mellitus Type II - glycated hemoglobin increase to 48mmol/mol
         subjects affected / exposed
    0 / 84 (0.00%)
    8 / 85 (9.41%)
         occurrences all number
    0
    8
    Musculoskeletal and connective tissue disorders
    Generalized muscle weakness
         subjects affected / exposed
    4 / 84 (4.76%)
    4 / 85 (4.71%)
         occurrences all number
    4
    4
    Myalgia
         subjects affected / exposed
    3 / 84 (3.57%)
    4 / 85 (4.71%)
         occurrences all number
    3
    4
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 84 (4.76%)
    7 / 85 (8.24%)
         occurrences all number
    4
    7
    Metabolism and nutrition disorders
    Anorexia
    Additional description: Loss of appetite
         subjects affected / exposed
    5 / 84 (5.95%)
    2 / 85 (2.35%)
         occurrences all number
    5
    2
    Hypercalcaemia
         subjects affected / exposed
    6 / 84 (7.14%)
    5 / 85 (5.88%)
         occurrences all number
    6
    5
    Hypocalcaemia
         subjects affected / exposed
    3 / 84 (3.57%)
    11 / 85 (12.94%)
         occurrences all number
    3
    11
    Hypercholesterolaemia
         subjects affected / exposed
    18 / 84 (21.43%)
    14 / 85 (16.47%)
         occurrences all number
    18
    14
    Hypokalemia
         subjects affected / exposed
    3 / 84 (3.57%)
    17 / 85 (20.00%)
         occurrences all number
    3
    17

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35709600
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