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    Clinical Trial Results:
    Neoadjuvant degarelix +/- apalutamide (ARN-509) followed by radical prostatectomy for intermediate and high-risk prostate cancer: a randomized, placebo-controlled trial.

    Summary
    EudraCT number
    		 2016-002854-19
    Trial protocol
    		 BE  
    Global end of trial date
    22 Jul 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2025
    First version publication date
    03 Jan 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    S58827
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 ClinicalTrial.gov: NCT03080116
    Sponsors
    Sponsor organisation name
    UZ Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Clinical Trial Center (CTC), UZ Leuven, ctc@uzleuven.be
    Scientific contact
    Clinical Trial Center (CTC), UZ Leuven, ctc@uzleuven.be
    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 Aug 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jul 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the difference in treatment antitumor effect between the treatment arms by measuring pathological tumor volume following radical prostatectomy.
    Protection of trial subjects
    Patients were seen on regular visits for safety follow-up including adverse events. No pain or distress was expected.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 2017
    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
    Belgium: 89
    Worldwide total number of subjects
    89
    EEA total number of subjects
    89
    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)
    32
    From 65 to 84 years
    57
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Eligible patients had unfavorable intermediate risk (defined as two or more of the following risk factors: bISUP 2-3, PSA 10–20 ng/ml and/or cT2b [MRI]) or high-risk PCa (bISUP 4-5, PSA >20 ng/ml, >= cT2c [MRI], and/or cN1) and were amenable to RP + ePLND. Exclusion: cM1, ECOG >1, neuroendocrine differentiation, contra-indication for ADT or APA

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Degarelix + Placebo
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Degarelix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Degarelix is administered monthly via injections. The first dose is 240 mg (2x 120 mg). Afterwards, there are monthly injections of 80 mg. This was performed twice. The total treatment period is 3 months.

    Arm title
    		 Degarelix + Apalutamide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Degarelix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Degarelix is administered monthly via injections. The first dose is 240 mg (2x 120 mg). Afterwards, there are monthly injections of 80 mg. This was performed twice. The total treatment period is 3 months.

    Investigational medicinal product name
    Apalutamide
    Investigational medicinal product code
    Other name
    ARN-509, Erleada
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daily oral intake of 240 mg of apalutamide. This is 4 tablets of 60 mg at the same time.

    Number of subjects in period 1
    		Degarelix + Placebo Degarelix + Apalutamide
    Started
    44
    45
    Completed
    44
    45

    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
    		 89 89
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 32 32
        From 65-84 years
    		 57 57
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 66 (61 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 89 89

    End points

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    End points reporting groups
    Reporting group title
    Degarelix + Placebo
    Reporting group description
    		 -

    Reporting group title
    Degarelix + Apalutamide
    Reporting group description
    		 -

    Primary: Minimal Residual Disease (MRD)

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    End point title
    		 Minimal Residual Disease (MRD)
    End point description
    End point type
    Primary
    End point timeframe
    Pathology was assessed after surgery.
    End point values
    		 Degarelix + Placebo Degarelix + Apalutamide
    Number of subjects analysed
    44
    45
    Units: 2
        No MRD
    40
    28
        MRD
    4
    17
    Statistical analysis title
    		 Fisher's Exact test
    Comparison groups
    Degarelix + Placebo v Degarelix + Apalutamide
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Fisher exact
    Confidence interval

    Secondary: pT-stage

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    End point title
    		 pT-stage
    End point description
    End point type
    Secondary
    End point timeframe
    Assessed at pathology.
    End point values
    		 Degarelix + Placebo Degarelix + Apalutamide
    Number of subjects analysed
    44
    45
    Units: 5
        ypT0
    0
    0
        ypT2
    12
    23
        ypT3a
    17
    12
        ypT3b
    15
    9
        ypT4
    0
    1
    Statistical analysis title
    		 Fisher’s exact test
    Comparison groups
    Degarelix + Placebo v Degarelix + Apalutamide
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.022
    Method
    		 Fisher exact
    Confidence interval

    Secondary: PSA nadir of <0.3 ng/ml

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    End point title
    		 PSA nadir of <0.3 ng/ml
    End point description
    End point type
    Secondary
    End point timeframe
    Assessed at the time of surgery.
    End point values
    		 Degarelix + Placebo Degarelix + Apalutamide
    Number of subjects analysed
    44
    45
    Units: 2
        PSA nadir <0.3 ng/ml
    4
    39
        PSA nadir >0.3 ng/ml
    40
    6
    Statistical analysis title
    		 Fisher’s exact test
    Comparison groups
    Degarelix + Placebo v Degarelix + Apalutamide
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Surgical Margin

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    End point title
    		 Surgical Margin
    End point description
    End point type
    Secondary
    End point timeframe
    Assessed at surgery.
    End point values
    		 Degarelix + Placebo Degarelix + Apalutamide
    Number of subjects analysed
    44
    45
    Units: 2
        Negative
    36
    37
        Positive
    8
    8
    Statistical analysis title
    		 Fisher’s exact test
    Comparison groups
    Degarelix + Placebo v Degarelix + Apalutamide
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Lymph node status

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    End point title
    		 Lymph node status
    End point description
    End point type
    Secondary
    End point timeframe
    Assessed after surgery.
    End point values
    		 Degarelix + Placebo Degarelix + Apalutamide
    Number of subjects analysed
    44
    45
    Units: 3
        pN0
    37
    35
        pN1
    7
    9
        pNx
    0
    1
    Statistical analysis title
    		 Fisher’s exact test
    Comparison groups
    Degarelix + Placebo v Degarelix + Apalutamide
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Fisher exact
    Confidence interval

    Secondary: BCR-free survival

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    End point title
    		 BCR-free survival
    End point description
    End point type
    Secondary
    End point timeframe
    Time between radical prostatectomy and BCR (or until last patients had a minimal follow-up of 3 years).
    End point values
    		 Degarelix + Placebo Degarelix + Apalutamide
    Number of subjects analysed
    44
    45
    Units: 100
    41
    31
    Statistical analysis title
    		 Log-rank test
    Comparison groups
    Degarelix + Placebo v Degarelix + Apalutamide
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3
    Method
    		 Logrank
    Confidence interval

    Secondary: Testosterone recovery

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    End point title
    		 Testosterone recovery
    End point description
    End point type
    Secondary
    End point timeframe
    Radical prostatectomy until testosterone recovery
    End point values
    		 Degarelix + Placebo Degarelix + Apalutamide
    Number of subjects analysed
    44
    45
    Units: Months
        median (inter-quartile range (Q1-Q3))
    6 (5 to 10)
    7 (5 to 11.5)
    Statistical analysis title
    		 Logrank
    Comparison groups
    Degarelix + Placebo v Degarelix + Apalutamide
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.15
    Method
    		 Logrank
    Confidence interval

    Secondary: Urinary incontinence @3Y

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    End point title
    		 Urinary incontinence @3Y
    End point description
    End point type
    Secondary
    End point timeframe
    At 3-year post-surgery
    End point values
    		 Degarelix + Placebo Degarelix + Apalutamide
    Number of subjects analysed
    44
    45
    Units: Urinary Incontinence scale
        arithmetic mean (confidence interval 95%)
    4.84 (3.54 to 6.15)
    4.58 (3.31 to 5.85)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Degarelix + Placebo v Degarelix + Apalutamide
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.77
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: IIEF5 @3Y

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    End point title
    		 IIEF5 @3Y
    End point description
    End point type
    Secondary
    End point timeframe
    At 3Y post-surgery
    End point values
    		 Degarelix + Placebo Degarelix + Apalutamide
    Number of subjects analysed
    44
    45
    Units: IIEF5 score
        arithmetic mean (confidence interval 95%)
    6.22 (4.95 to 7.5)
    6.31 (5.06 to 7.56)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Degarelix + Placebo v Degarelix + Apalutamide
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.92
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Global health QLQ @3Y

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    End point title
    		 Global health QLQ @3Y
    End point description
    End point type
    Secondary
    End point timeframe
    At 3Y post-surgery
    End point values
    		 Degarelix + Placebo Degarelix + Apalutamide
    Number of subjects analysed
    44
    45
    Units: QLQ30 Global health score
        arithmetic mean (confidence interval 95%)
    75.12 (69.52 to 80.72)
    74.81 (69.37 to 80.24)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Degarelix + Placebo v Degarelix + Apalutamide
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.94
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    3-month period prior to RP
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    ADT + PLB
    Reporting group description
    		 -

    Reporting group title
    ADT + APA
    Reporting group description
    		 -

    Serious adverse events
    		 ADT + PLB ADT + APA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 44 (2.27%)
    6 / 45 (13.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Social circumstances
    Insomnia
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 45 (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
    Dyspnoea
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 44 (0.00%)
    4 / 45 (8.89%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 ADT + PLB ADT + APA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 44 (100.00%)
    45 / 45 (100.00%)
    Social circumstances
    Hot flush
         subjects affected / exposed
    42 / 44 (95.45%)
    43 / 45 (95.56%)
         occurrences all number
    42
    43
    Fatigue
         subjects affected / exposed
    17 / 44 (38.64%)
    17 / 45 (37.78%)
         occurrences all number
    17
    17
    Insomnia
         subjects affected / exposed
    8 / 44 (18.18%)
    9 / 45 (20.00%)
         occurrences all number
    8
    9
    Headache
         subjects affected / exposed
    4 / 44 (9.09%)
    4 / 45 (8.89%)
         occurrences all number
    4
    4
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    2 / 44 (4.55%)
    5 / 45 (11.11%)
         occurrences all number
    2
    5
    Ejaculation disorder
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Libido decreased
         subjects affected / exposed
    1 / 44 (2.27%)
    2 / 45 (4.44%)
         occurrences all number
    1
    2
    Gynaecomastia
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 44 (0.00%)
    4 / 45 (8.89%)
         occurrences all number
    0
    4
    Psychiatric disorders
    Depression
         subjects affected / exposed
    3 / 44 (6.82%)
    1 / 45 (2.22%)
         occurrences all number
    3
    1
    Irritability
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Hypersomnia
         subjects affected / exposed
    0 / 44 (0.00%)
    2 / 45 (4.44%)
         occurrences all number
    0
    2
    Memory impairment
         subjects affected / exposed
    3 / 44 (6.82%)
    5 / 45 (11.11%)
         occurrences all number
    3
    5
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    17 / 44 (38.64%)
    16 / 45 (35.56%)
         occurrences all number
    17
    16
    Leukopenia
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 44 (0.00%)
    2 / 45 (4.44%)
         occurrences all number
    0
    2
    Epistaxis
         subjects affected / exposed
    0 / 44 (0.00%)
    5 / 45 (11.11%)
         occurrences all number
    0
    5
    Ear and labyrinth disorders
    Dizziness
         subjects affected / exposed
    2 / 44 (4.55%)
    3 / 45 (6.67%)
         occurrences all number
    2
    3
    Eye disorders
    Blurred vision
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    8 / 44 (18.18%)
    8 / 45 (17.78%)
         occurrences all number
    8
    8
    Diarrhea
         subjects affected / exposed
    3 / 44 (6.82%)
    3 / 45 (6.67%)
         occurrences all number
    3
    3
    Obstipation
         subjects affected / exposed
    2 / 44 (4.55%)
    2 / 45 (4.44%)
         occurrences all number
    2
    2
    Flatulency
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Dysgeusia
         subjects affected / exposed
    1 / 44 (2.27%)
    6 / 45 (13.33%)
         occurrences all number
    1
    6
    Nausea
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Loss of appetite
         subjects affected / exposed
    1 / 44 (2.27%)
    3 / 45 (6.67%)
         occurrences all number
    1
    3
    Increased appetite
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Bloating
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Reflux
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    ALT increase
         subjects affected / exposed
    8 / 44 (18.18%)
    10 / 45 (22.22%)
         occurrences all number
    8
    10
    AST increase
         subjects affected / exposed
    6 / 44 (13.64%)
    8 / 45 (17.78%)
         occurrences all number
    6
    8
    Bilirubin increase
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    8 / 44 (18.18%)
    8 / 45 (17.78%)
         occurrences all number
    8
    8
    Rash
         subjects affected / exposed
    6 / 44 (13.64%)
    14 / 45 (31.11%)
         occurrences all number
    6
    14
    Pruritus
         subjects affected / exposed
    4 / 44 (9.09%)
    8 / 45 (17.78%)
         occurrences all number
    4
    8
    Nail discolouration
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Peri-orbital edema
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Edema hands
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Urinary frequency
         subjects affected / exposed
    5 / 44 (11.36%)
    2 / 45 (4.44%)
         occurrences all number
    5
    2
    Urinary Urgency
         subjects affected / exposed
    1 / 44 (2.27%)
    3 / 45 (6.67%)
         occurrences all number
    1
    3
    Urinary mictalgia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Urinary nycturia
         subjects affected / exposed
    4 / 44 (9.09%)
    8 / 45 (17.78%)
         occurrences all number
    4
    8
    Musculoskeletal and connective tissue disorders
    Musculoskeletal disorder
         subjects affected / exposed
    6 / 44 (13.64%)
    5 / 45 (11.11%)
         occurrences all number
    6
    5
    Chest pain
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1

    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.
    See publication.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36167599
    http://www.ncbi.nlm.nih.gov/pubmed/29606109
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