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    Clinical Trial Results:
    Randomized, open-label, parallel-group, multi-centre phase II clinical trial with active cellular immunotherapy DCVAC/PCa in patients with localized high-risk prostate cancer after primary radiotherapy

    Summary
    EudraCT number
    		 2011-004967-65
    Trial protocol
    		 CZ  
    Global end of trial date
    11 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2019
    First version publication date
    23 Oct 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SP004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02107430
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    SOTIO a.s.
    Sponsor organisation address
    Jankovcova 1518/2, Prague, Czech Republic,
    Public contact
    Clinical Trials SOTIO, SOTIO a.s., +420 224175111, clinicaltrial@sotio.com
    Scientific contact
    Clinical Trials SOTIO, SOTIO a.s., +420 224175111, clinicaltrial@sotio.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of study SP004 was to estimate the survival rate of patients without prostate-specific antigen (PSA) failure, the survival rate of patients without initiation of salvage therapy 5 years after randomization, time to objective disease progression, overall survival (OS), and the incidence of adverse events (AEs).
    Protection of trial subjects
    Not applicable
    Background therapy
    		 Both treatment groups started radiotherapy 4 weeks (±1 week) after randomization. A minimum dose of 44 Gy targeted at the small pelvis (22 fractions delivered over 4 weeks + 2 days or a biologically equivalent dose) and a minimum dose of 74 Gy at the prostate ± seminal vesicles (37 fractions delivered over 7 weeks + 2 days or a biologically equivalent dose) were administered. Both treatment groups continued neoadjuvant androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) analogs during radiotherapy and started adjuvant ADT with LHRH analogs or bicalutamide within 1 week after the end of radiotherapy. Adjuvant ADT continued for at least 2 years.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    28 Mar 2012
    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
    Czech Republic: 62
    Worldwide total number of subjects
    62
    EEA total number of subjects
    62
    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)
    16
    From 65 to 84 years
    46
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Nine clinical study sites in the Czech Republic participated in the study, and 6 screened at least 1 patient. Recruitment started on 28-Mar-2012 (first patient signed the informed consent form).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Immuno-therapy group
    Arm description
    		 DCVAC/PCa combined with radiotherapy and ADT; patients in the immunotherapy group were treated with 50 mg/day of oral cyclophosphamide for 7 days before the first dose of DCVAC/PCa and applied imiquimod cream to the planned DCVAC/PCa injection sites 24 hours before each DCVAC/PCa administration
    Arm type
    		 Experimental

    Investigational medicinal product name
    DCVAC/PCa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of approximately 1×10e7 autologous dendritic cells; oral cyclophosphamide 50 mg/day for 7 days before the first dose of DCVAC/PCa; imiquimod cream applied to the planned DCVAC/PCa injection sites 24 hours before each DCVAC/PCa administration

    Arm title
    		 Control group
    Arm description
    		 Radiotherapy and ADT alone
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Immuno-therapy group Control group
    Started
    31
    31
    Completed
    22
    17
    Not completed
    9
    14
         End of study visit earlier than per Protocol
    1
    -
         Consent withdrawn by subject
    4
    5
         Physician decision
    1
    1
         Adverse event, non-fatal
    -
    3
         Reason not available
    -
    1
         Death
    3
    1
         Protocol deviation
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Immuno-therapy group
    Reporting group description
    		 DCVAC/PCa combined with radiotherapy and ADT; patients in the immunotherapy group were treated with 50 mg/day of oral cyclophosphamide for 7 days before the first dose of DCVAC/PCa and applied imiquimod cream to the planned DCVAC/PCa injection sites 24 hours before each DCVAC/PCa administration

    Reporting group title
    Control group
    Reporting group description
    		 Radiotherapy and ADT alone

    Reporting group values
    		 Immuno-therapy group Control group Total
    Number of subjects
    		 31 31 62
    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)
    		 10 6 16
        From 65-84 years
    		 21 25 46
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 31 31 62

    End points

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    End points reporting groups
    Reporting group title
    Immuno-therapy group
    Reporting group description
    		 DCVAC/PCa combined with radiotherapy and ADT; patients in the immunotherapy group were treated with 50 mg/day of oral cyclophosphamide for 7 days before the first dose of DCVAC/PCa and applied imiquimod cream to the planned DCVAC/PCa injection sites 24 hours before each DCVAC/PCa administration

    Reporting group title
    Control group
    Reporting group description
    		 Radiotherapy and ADT alone

    Subject analysis set title
    Intention-to-treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intention-to-treat (ITT) population consisted of all randomized patients except those for whom no data were available following the Randomization visit. More precisely, patients who did not have any post-randomization visit and any data regarding survival follow-up were excluded from the ITT population.

    Subject analysis set title
    Per Protocol set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol set (PPS) was defined as a subset of the ITT population from which all patients with a significant protocol deviation were excluded. The following was considered as a significant protocol deviation: i) Not meeting 1 or more inclusion criteria; ii) Meeting 1 or more exclusion criteria; iii) Treatment assignment error; iv) Use of prohibited concomitant medication; v) Serious non-compliance with treatment regimen; vi) Missed essential assessment. Patients who were randomized to the immunotherapy group and did not receive any dose of DCVAC/PCa for any reason (including leukapheresis or production failure) were not included in the PPS. In the same manner, patients who were randomized to the control group but discontinued before or at Visit 1 were not included in the PPS. Patients who did not undergo radiotherapy/ were not using appropriate ADT or used a prohibited concomitant medication were not included in the PPS.

    Primary: Proportion of patients alive who were without PSA failure at 5 years after randomization, ITT population (patients alive 5 years after randomization: immunotherapy group - 26 patients, control group - 23 patients)

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    End point title
    		 Proportion of patients alive who were without PSA failure at 5 years after randomization, ITT population (patients alive 5 years after randomization: immunotherapy group - 26 patients, control group - 23 patients)
    End point description
    End point type
    Primary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    26 [1]
    23 [2]
    Units: Patients
    18
    15
    Notes
    [1] - Patients alive 5 years after randomization
    [2] - Patients alive 5 years after randomization
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Primary: Proportion of patients alive who were without PSA failure at 5 years after randomization, ITT population (all patients)

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    End point title
    		 Proportion of patients alive who were without PSA failure at 5 years after randomization, ITT population (all patients)
    End point description
    End point type
    Primary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: Patients
    18
    15
    Statistical analysis title
    		 Primary
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6111
    Method
    		 Fisher exact
    Confidence interval

    Primary: Time to PSA failure, ITT population (main analysis)

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    End point title
    		 Time to PSA failure, ITT population (main analysis)
    End point description
    End point type
    Primary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: month
        arithmetic mean (standard error)
    43.58 ± 1.664
    53.44 ± 1.836
    Statistical analysis title
    		 Main analysis
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6847
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.733
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.164
         upper limit
    		 3.278

    Secondary: Time to PSA failure, ITT population (sensitivity analysis A)

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    End point title
    		 Time to PSA failure, ITT population (sensitivity analysis A)
    End point description
    Sensitivity analysis A: An analysis using the ITT population based on data until the End of study visit only
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: month
        arithmetic mean (standard error)
    43.51 ± 1.721
    49.56 ± 1.853
    Statistical analysis title
    		 Sensitivity analysis A
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9588
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.959
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.193
         upper limit
    		 4.751

    Secondary: Time to PSA failure, ITT population (sensitivity analysis B)

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    End point title
    		 Time to PSA failure, ITT population (sensitivity analysis B)
    End point description
    Sensitivity analysis B: An analysis using the ITT population in which data from patients using adjuvant ADT for less than 2 years were used only until the end of ADT + 3 months
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: month
        arithmetic mean (standard error)
    43.58 ± 1.664
    53.28 ± 1.894
    Statistical analysis title
    		 Sensitivity analysis B
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6792
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.729
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.163
         upper limit
    		 3.26

    Secondary: Time to PSA failure, PPS (sensitivity analysis C)

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    End point title
    		 Time to PSA failure, PPS (sensitivity analysis C)
    End point description
    Sensitivity analysis C: An analysis using the PPS
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    19
    11
    Units: month
        arithmetic mean (standard error)
    12.49 ± 1000000
    1000000 ± 1000000
    Statistical analysis title
    		 Sensitivity analysis C
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9985
    Method
    		 Regression, Cox
    Confidence interval

    Secondary: Proportion of patients without salvage therapy 5 years after randomization, ITT population (patients alive 5 years after randomization: immunotherapy group - 26 patients, control group - 23 patients)

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    End point title
    		 Proportion of patients without salvage therapy 5 years after randomization, ITT population (patients alive 5 years after randomization: immunotherapy group - 26 patients, control group - 23 patients)
    End point description
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    26 [3]
    23 [4]
    Units: Patients
    18
    15
    Notes
    [3] - Patients alive 5 years after randomization
    [4] - Patients alive 5 years after randomization
    Statistical analysis title
    		 Secondary analysis
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Proportion of patients without salvage therapy 5 years after randomization, ITT population (all patients)

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    End point title
    		 Proportion of patients without salvage therapy 5 years after randomization, ITT population (all patients)
    End point description
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: Patients
    18
    15
    Statistical analysis title
    		 Secondary analysis
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6111
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Time to initiation of salvage therapy, ITT population (main analysis)

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    End point title
    		 Time to initiation of salvage therapy, ITT population (main analysis)
    End point description
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: months
        arithmetic mean (standard error)
    48.42 ± 0.102
    54.21 ± 1.784
    Statistical analysis title
    		 Main analysis
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6429
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.655
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.109
         upper limit
    		 3.92

    Secondary: Time to initiation of salvage therapy, ITT population (sensitivity analysis A)

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    End point title
    		 Time to initiation of salvage therapy, ITT population (sensitivity analysis A)
    End point description
    Sensitivity analysis A: An analysis using the ITT population based on data until the End of study visit only
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: month
        arithmetic mean (standard error)
    48.42 ± 0.102
    54.09 ± 1.913
    Statistical analysis title
    		 Sensitivity analysis A
    Comparison groups
    Control group v Immuno-therapy group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5933
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.614
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.103
         upper limit
    		 3.677

    Secondary: Time to initiation of salvage therapy, ITT population (sensitivity analysis B)

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    End point title
    		 Time to initiation of salvage therapy, ITT population (sensitivity analysis B)
    End point description
    Sensitivity analysis B: An analysis using the ITT population in which data from patients using adjuvant ADT for less than 2 years were used only until the end of ADT + 3 months
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: month
        arithmetic mean (standard error)
    48.40 ± 0.122
    54.20 ± 1.784
    Statistical analysis title
    		 Sensitivity analysis B
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6398
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.652
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.109
         upper limit
    		 3.904

    Secondary: Time to initiation of salvage therapy, PPS (sensitivity analysis C)

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    End point title
    		 Time to initiation of salvage therapy, PPS (sensitivity analysis C)
    End point description
    Sensitivity analysis C: An analysis using the PPS
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    19
    11
    Units: month
        arithmetic mean (standard error)
    1000000 ± 1000000
    1000000 ± 1000000
    No statistical analyses for this end point

    Secondary: Proportion of patients alive who were without objective disease progression at 5 years after randomization, ITT population (patients alive 5 years after randomization: immunotherapy group - 26 patients, control group - 23 patients) – approach A

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    End point title
    		 Proportion of patients alive who were without objective disease progression at 5 years after randomization, ITT population (patients alive 5 years after randomization: immunotherapy group - 26 patients, control group - 23 patients) – approach A
    End point description
    Approach A: Disease progression-free patients were those for whom an objective tumor assessment (CT scan and scintigraphy) 5 years after randomization shows evidence of NON-progressive disease.
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    26 [5]
    23 [6]
    Units: Patients
    20
    16
    Notes
    [5] - Patients alive 5 years after randomization
    [6] - Patients alive 5 years after randomization
    Statistical analysis title
    		 Secondary analysis
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7471
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Proportion of patients alive who were without objective disease progression at 5 years after randomization, ITT population (all patients) – approach A

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    End point title
    		 Proportion of patients alive who were without objective disease progression at 5 years after randomization, ITT population (all patients) – approach A
    End point description
    Approach A: Disease progression-free patients were those for whom an objective tumor assessment (CT scan and scintigraphy) 5 years after randomization shows evidence of NON-progressive disease.
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: Patients
    20
    16
    Statistical analysis title
    		 Secondary analysis
    Comparison groups
    Control group v Immuno-therapy group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4404
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Proportion of patients alive who were without objective disease progression at 5 years after randomization, ITT population (patients alive 5 years after randomization: immunotherapy group - 26 patients, control group - 23 patients) – approach B

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    End point title
    		 Proportion of patients alive who were without objective disease progression at 5 years after randomization, ITT population (patients alive 5 years after randomization: immunotherapy group - 26 patients, control group - 23 patients) – approach B
    End point description
    Approach B: Disease progression-free patients were those for whom an objective tumor assessment (CT scan and scintigraphy) 5 years after randomization shows evidence of NON-progressive disease, and for whom an objective tumor assessment was missed but there is a reliable evidence of stable disease based on PSA values measured regularly as per the Protocol schedule until 5 years after randomization (i.e., no PSA failure was observed).
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    26 [7]
    23 [8]
    Units: Patients
    21
    17
    Notes
    [7] - Patients alive 5 years after randomization
    [8] - Patients alive 5 years after randomization
    Statistical analysis title
    		 Secondary analysis
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7341
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Proportion of patients alive who were without objective disease progression at 5 years after randomization, ITT population (all patients) – approach B

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    End point title
    		 Proportion of patients alive who were without objective disease progression at 5 years after randomization, ITT population (all patients) – approach B
    End point description
    Approach B: Disease progression-free patients were those for whom an objective tumor assessment (CT scan and scintigraphy) 5 years after randomization shows evidence of NON-progressive disease, and for whom an objective tumor assessment was missed but there is a reliable evidence of stable disease based on PSA values measured regularly as per the Protocol schedule until 5 years after randomization (i.e., no PSA failure was observed).
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: Patients
    21
    17
    Statistical analysis title
    		 Secondary analysis
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4345
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Time to objective disease progression, ITT population (main analysis) – approach A

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    End point title
    		 Time to objective disease progression, ITT population (main analysis) – approach A
    End point description
    Approach A: Disease progression-free patients were those for whom an objective tumor assessment (CT scan and scintigraphy) 5 years after randomization shows evidence of NON-progressive disease.
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: month
        arithmetic mean (standard error)
    44.14 ± 2.443
    51.57 ± 2.211
    Statistical analysis title
    		 Main analysis
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9967
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1.002
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.363
         upper limit
    		 2.764

    Secondary: Time to objective disease progression, ITT population (main analysis) – approach B

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    End point title
    		 Time to objective disease progression, ITT population (main analysis) – approach B
    End point description
    Approach B: Disease progression-free patients were those for whom an objective tumor assessment (CT scan and scintigraphy) 5 years after randomization shows evidence of NON-progressive disease, and for whom an objective tumor assessment was missed but there is a reliable evidence of stable disease based on PSA values measured regularly as per the Protocol schedule until 5 years after randomization (i.e., no PSA failure was observed).
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: month
        arithmetic mean (standard error)
    44.32 ± 2.369
    52.02 ± 1.984
    Statistical analysis title
    		 Main analysis
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.895
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1.071
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.388
         upper limit
    		 2.954

    Secondary: Time to objective disease progression, ITT population (sensitivity analysis B) – approach A

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    End point title
    		 Time to objective disease progression, ITT population (sensitivity analysis B) – approach A
    End point description
    Sensitivity analysis B: An analysis using the ITT population in which data from patients using adjuvant ADT for less than 2 years were to be used only until the end of ADT + 3 months Approach A: Disease progression-free patients were those for whom an objective tumor assessment (CT scan and scintigraphy) 5 years after randomization shows evidence of NON-progressive disease
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: month
        arithmetic mean (standard error)
    43.50 ± 2.692
    50.73 ± 2.606
    Statistical analysis title
    		 Sensitivity analysis B
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8788
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.924
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.335
         upper limit
    		 2.549

    Secondary: Time to objective disease progression, ITT population (sensitivity analysis B) – approach B

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    End point title
    		 Time to objective disease progression, ITT population (sensitivity analysis B) – approach B
    End point description
    Sensitivity analysis B: Analysis using the ITT population in which data from patients using adjuvant ADT for less than 2 years were to be used only until the end of ADT + 3 months Approach B: Disease progression-free patients were those for whom an objective tumor assessment (CT scan and scintigraphy) 5 years after randomization shows evidence of NON-progressive disease, and for whom an objective tumor assessment was missed but there is a reliable evidence of stable disease based on PSA values measured regularly as per the Protocol schedule until 5 years after randomization (i.e., no PSA failure was observed)
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: month
        arithmetic mean (standard error)
    44.13 ± 2.410
    51.62 ± 2.092
    Statistical analysis title
    		 Sensitivity analysis B
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9078
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1.062
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.385
         upper limit
    		 2.93

    Secondary: Time to objective disease progression, PPS (sensitivity analysis C) – approach A

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    End point title
    		 Time to objective disease progression, PPS (sensitivity analysis C) – approach A
    End point description
    Sensitivity analysis C: An analysis using the PPS Approach A: Disease progression-free patients were those for whom an objective tumor assessment (CT scan and scintigraphy) 5 years after randomization shows evidence of NON-progressive disease
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    19
    11
    Units: month
        arithmetic mean (standard error)
    28.20 ± 1.167
    44.31 ± 0.290
    Statistical analysis title
    		 Sensitivity analysis C
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5886
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.582
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.082
         upper limit
    		 4.135

    Secondary: Time to objective disease progression, PPS (sensitivity analysis C) – approach B

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    End point title
    		 Time to objective disease progression, PPS (sensitivity analysis C) – approach B
    End point description
    Sensitivity analysis C: An analysis using the PPS Approach B: Disease progression-free patients were those for whom an objective tumor assessment (CT scan and scintigraphy) 5 years after randomization shows evidence of NON-progressive disease, and for whom an objective tumor assessment was missed but there is a reliable evidence of stable disease based on PSA values measured regularly as per the Protocol schedule until 5 years after randomization (i.e., no PSA failure was observed)
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    19
    11
    Units: month
        arithmetic mean (standard error)
    28.20 ± 1.167
    44.33 ± 0.265
    Statistical analysis title
    		 Sensitivity analysis C
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6578
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.642
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.09
         upper limit
    		 4.56

    Secondary: Proportion of patients who were alive 5 years after randomization, overall survival, ITT population

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    End point title
    		 Proportion of patients who were alive 5 years after randomization, overall survival, ITT population
    End point description
    End point type
    Secondary
    End point timeframe
    From randomization to 5 years after randomization
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: Patients
    26
    23
    Statistical analysis title
    		 Secondary analysis
    Comparison groups
    Control group v Immuno-therapy group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5339
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Overall survival, ITT population

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    End point title
    		 Overall survival, ITT population
    End point description
    End point type
    Secondary
    End point timeframe
    From randomization to the end of the study
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: month
        arithmetic mean (standard error)
    45.90 ± 2.065
    47.85 ± 1.036
    Statistical analysis title
    		 Secondary analysis
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9711
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1.023
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.296
         upper limit
    		 3.536

    Secondary: Overall survival, ITT population (sensitivity analysis B)

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    End point title
    		 Overall survival, ITT population (sensitivity analysis B)
    End point description
    Sensitivity analysis B: An analysis using the ITT population in which data from patients using adjuvant ADT for less than 2 years were to be used only until the end of ADT + 3 months
    End point type
    Secondary
    End point timeframe
    From randomization to the end of the study
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    31
    31
    Units: month
        arithmetic mean (standard error)
    45.74 ± 2.116
    47.64 ± 1.142
    Statistical analysis title
    		 Sensitivity analysis B
    Comparison groups
    Control group v Immuno-therapy group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9547
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1.037
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 3.583

    Secondary: Overall survival, PPS (sensitivity analysis C)

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    End point title
    		 Overall survival, PPS (sensitivity analysis C)
    End point description
    Sensitivity analysis C: An analysis using the PPS
    End point type
    Secondary
    End point timeframe
    From randomization to the end of the study
    End point values
    		 Immuno-therapy group Control group
    Number of subjects analysed
    19
    11
    Units: month
        arithmetic mean (standard error)
    28.25 ± 1.107
    44.33 ± 0.265
    Statistical analysis title
    		 Sensitivity analysis C
    Comparison groups
    Immuno-therapy group v Control group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6163
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.606
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.085
         upper limit
    		 4.302

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs): from Visit 1 (start of DCVAC/PCa in the immunotherapy group) to 30 days after Visit 10/ the End of treatment visit (30 days after the last dose of DCVAC/PCa in the immunotherapy group). Deaths: from consent signature to study end
    Adverse event reporting additional description
    Only treatment-emergent AEs (TEAEs) were analyzed. The tables include information on TEAEs, serious TEAEs, and all deaths. Causality was assessed by investigators. A suspected unexpected serious adverse reaction (lymphedema) was reported in one patient.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Immuno-therapy group
    Reporting group description
    		 -

    Reporting group title
    Control group
    Reporting group description
    		 -

    Serious adverse events
    		 Immuno-therapy group Control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 30 (10.00%)
    4 / 29 (13.79%)
         number of deaths (all causes)
    5
    5
         number of deaths resulting from adverse events
    1
    0
    Vascular disorders
    Venous thrombosis limb
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urethral obstruction
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         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
    1 / 30 (3.33%)
    0 / 29 (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: 5%
    Non-serious adverse events
    		 Immuno-therapy group Control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 30 (93.33%)
    29 / 29 (100.00%)
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Weight increased
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Injury, poisoning and procedural complications
    Cystitis radiation
         subjects affected / exposed
    3 / 30 (10.00%)
    5 / 29 (17.24%)
         occurrences all number
    3
    5
    Gastroenteritis radiation
         subjects affected / exposed
    3 / 30 (10.00%)
    5 / 29 (17.24%)
         occurrences all number
    3
    5
    Radiation proctitis
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Radiation sickness syndrome
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    3
    Vascular disorders
    Hot flush
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    Hypertension
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Atrial fibrillation
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 30 (6.67%)
    6 / 29 (20.69%)
         occurrences all number
    2
    6
    Oedema peripheral
         subjects affected / exposed
    5 / 30 (16.67%)
    2 / 29 (6.90%)
         occurrences all number
    5
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Diarrhoea
         subjects affected / exposed
    1 / 30 (3.33%)
    7 / 29 (24.14%)
         occurrences all number
    1
    7
    Faeces soft
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Gynaecomastia
         subjects affected / exposed
    5 / 30 (16.67%)
    7 / 29 (24.14%)
         occurrences all number
    5
    7
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Skin burning sensation
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 30 (3.33%)
    4 / 29 (13.79%)
         occurrences all number
    1
    4
    Nocturia
         subjects affected / exposed
    5 / 30 (16.67%)
    3 / 29 (10.34%)
         occurrences all number
    5
    3
    Renal failure
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Urinary retention
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 30 (6.67%)
    4 / 29 (13.79%)
         occurrences all number
    2
    4
    Back pain
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    3
    Joint swelling
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Pain in extremity
         subjects affected / exposed
    0 / 30 (0.00%)
    4 / 29 (13.79%)
         occurrences all number
    0
    4
    Infections and infestations
    Epididymitis
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Influenza
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    3
    Urinary tract infection
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Viral infection
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 29 (10.34%)
         occurrences all number
    2
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Diabetes mellitus
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Hyperglycaemia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Hypokalaemia
         subjects affected / exposed
    2 / 30 (6.67%)
    5 / 29 (17.24%)
         occurrences all number
    2
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Dec 2011
    - European Pharminvent Services to be responsible for pharmacovigilance services - Added specification of assessment for leukapheresis technical feasibility (vein access evaluation) prior the procedure for patients in immunotherapy group - Specification for HIV tests was added (CE marked kits; accredited laboratory) - Updated exclusion criteria to rule out patients indicated for chemotherapy (docetaxel and prednisone)
    05 Mar 2012
    - Updated visit schedule to clarify how active cellular immunotherapy will be applied in connection with RT - Updated SAE reporting - Exclusion criterion E9 was updated to be more general - Updated information on ADT dosing - Updated sampling period for Immunology and Immunomonitoring - Clarification of cyclophosphamide dosing - Details provided about CT/scintigraphy readings - Added criteria for early patient termination in the study - Active cellular immunotherapy transport and application description updated - PSA Failure terminology update
    13 Dec 2012
    - Updated instruction for ADT during RT based on 2012 European Association of Urology Guidelines on Prostate Cancer)
    11 Jun 2015
    - Detailed description of exploratory objectives, endpoints and analysis - Clearly distinguishing IMP from stimulating medication - Detailed description of laboratory testing performed, including samples for research - Statistical analysis section updated - Information about phase I/II clinical trials conducted by University Hospital in Motol updated per current knowledge - Section on concomitant medication was updated - Updated safety reporting sections, including the transfer of safety monitoring responsibilities from European Pharminvent Services to SOTIO a.s. - New term introduction: EoT, EoS, EoS Examination visit, Follow-up and Survival Follow-up - Updated section Rationale for Prostate Cancer Immunotherapy - Terminology harmonization
    29 May 2018
    - Adding collection of data of PSA levels and salvage therapy in the survival follow-up - Signature page according to new Standard Operating Procedure

    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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