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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 castrate-resistant prostate cancer

    Summary
    EudraCT number
    		 2011-004735-32
    Trial protocol
    		 CZ  
    Global end of trial date
    22 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Mar 2018
    First version publication date
    04 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SP001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02105675
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sotio a.s.
    Sponsor organisation address
    Jankovcova 1518/2, Prague, Czech Republic, 170 00
    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
    22 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of this clinical trial were to estimate the survival rate of patients 34 months after randomization; to estimate the proportion of patients without disease progression and without PSA progression 34 months after randomization; to evaluate quality of life and pain scale scoring using the standardized European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30, version 3; and to evaluate the incidence of AEs (with the exception of disease progression-related AEs).
    Protection of trial subjects
    Not applicable
    Background therapy
    		 Docetaxel 75 mg/m2 at 3-week intervals combined with prednisone 5 mg orally twice daily
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    24 Feb 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)
    20
    From 65 to 84 years
    42
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 18 clinical study centers in the Czech Republic participated in the study, and 13 screened at least 1 patient onto the study. Recruitment period started on 24-Feb-2012 (first patient signed the informed consent form) and ended on 28-Feb-2014 (last patient signed the informed consent form).

    Pre-assignment
    Screening details
    		 Screened: 87 Randomized: 62 Analyzed for efficacy: 47 Analyzed for safety: 47

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Immunotherapy group
    Arm description
    		 DCVAC/PCa in combination with chemotherapy; 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
    Not applicable
    Other name
    Not applicable
    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
    		 Chemotherapy alone
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Immunotherapy group Control group
    Started
    31
    31
    Completed
    2
    4
    Not completed
    29
    27
         Physician decision
    4
    3
         Consent withdrawn by subject
    5
    7
         Adverse event, non-fatal
    3
    2
         Death due to underlying disease
    6
    6
         Manufacturing failure
    3
    -
         Progressive disease
    6
    9
         Protocol deviation
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Immunotherapy group
    Reporting group description
    		 DCVAC/PCa in combination with chemotherapy; 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
    		 Chemotherapy alone

    Reporting group values
    		 Immunotherapy group Control group Total
    Number of subjects
    		 31 31 62
    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))
    		 67.0 (51.79 to 82.36) 70.38 (44.87 to 81.25) -
    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
    Immunotherapy group
    Reporting group description
    		 DCVAC/PCa in combination with chemotherapy; 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
    		 Chemotherapy alone

    Subject analysis set title
    mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized patients who started chemotherapy except those for whom no data were available following the randomization visit. It was not clinically meaningful to include patients who did not start chemotherapy as the information from these patients did not reflect the real effect of the study treatment. Therefore, the mITT population was the primary population when evaluating the study endpoints.

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized patients who received at least 1 dose of chemotherapy (control group) and, at the same time, received at least 1 dose of DCVAC/PCa (immunotherapy group)

    Primary: Survival rate of patients 34 months after randomization

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    End point title
    		 Survival rate of patients 34 months after randomization
    End point description
    End point type
    Primary
    End point timeframe
    34 months after randomization
    End point values
    		 Immunotherapy group Control group
    Number of subjects analysed
    25 [1]
    22 [2]
    Units: Proportion of pts alive at 34 months
        number (confidence interval 95%)
    0.360 (0.182 to 0.542)
    0.500 (0.282 to 0.684)
    Notes
    [1] - mITT
    [2] - mITT
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    Kaplan-Meier analysis and log-rank test
    Comparison groups
    Control group v Immunotherapy group
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2791
    Method
    		 Logrank
    Confidence interval

    Secondary: Survival rate of patients without disease progression and without PSA progression 34 months after randomization

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    End point title
    		 Survival rate of patients without disease progression and without PSA progression 34 months after randomization
    End point description
    Disease progression was defined as at least 2 additional lesions on bone scintigraphy and/or a new finding in soft tissues as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; PSA progression was defined as 2 consecutive increases by at least 2 ng/mL at least 2 weeks apart and by >25% above the nadir or baseline value. The main analysis used the start of chemotherapy as baseline.
    End point type
    Secondary
    End point timeframe
    34 months after randomization
    End point values
    		 Immunotherapy group Control group
    Number of subjects analysed
    25 [3]
    22 [4]
    Units: Proportion of pts without progression
        number (confidence interval 95%)
    0 (0 to 0)
    0.051 (0.004 to 0.209)
    Notes
    [3] - mITT
    [4] - mITT
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    Kaplan-Meier analysis and log-rank test
    Comparison groups
    Immunotherapy group v Control group
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3196
    Method
    		 Logrank
    Confidence interval

    Secondary: Survival rate of patients without disease progression 34 months after randomization

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    End point title
    		 Survival rate of patients without disease progression 34 months after randomization
    End point description
    Disease progression was defined as at least 2 additional lesions on bone scintigraphy and/or a new finding in soft tissues as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The main analysis used the start of chemotherapy as baseline.
    End point type
    Secondary
    End point timeframe
    34 months after randomization
    End point values
    		 Immunotherapy group Control group
    Number of subjects analysed
    25 [5]
    22 [6]
    Units: Proportion of pts alive w/o progression
        number (confidence interval 95%)
    0.048 (0.004 to 0.196)
    0.134 (0.027 to 0.329)
    Notes
    [5] - mITT
    [6] - mITT
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    Kaplan-Meier analysis and log-rank test
    Comparison groups
    Immunotherapy group v Control group
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1803
    Method
    		 Logrank
    Confidence interval

    Secondary: Quality of life (Global health status) as per the standardized EORTC QLQ-C30 version 3 questionnaire

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    End point title
    		 Quality of life (Global health status) as per the standardized EORTC QLQ-C30 version 3 questionnaire
    End point description
    Mean profiles of scales and items of the EORTC QLQ-C30 version 3 questionnaire display for each visit the mean ±1.96× standard error of the mean and the number of patients who completed the questionnaire. These profiles showed that mean scores of all items of the EORTC QLQ-C30 version 3 questionnaire were comparable in both treatment groups. A repeated measurement analysis was performed to investigate whether treatment, baseline score, time (i.e., visit), or interaction of treatment with time (visit) had an effect on the scores of the Global health status. The baseline score was the only factor having a statistically significant effect on the scores of the Global health status (p <0.0001).
    End point type
    Secondary
    End point timeframe
    34 months after randomization
    End point values
    		 Immunotherapy group Control group
    Number of subjects analysed
    25 [7]
    22 [8]
    Units: Not applicable
        number (not applicable)
    0
    0
    Notes
    [7] - mITT
    [8] - mITT
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    A repeated measurement analysis was performed using a marginal model with a robust covariance matrix. As a response variable, the scores for “on-treatment” visits with more than 10 patients with an available score in either treatment group were included. As explanatory variables, terms for treatment, baseline score, time (i.e., visit), and an interaction for treatment and time were included.
    Comparison groups
    Control group v Immunotherapy group
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6349 [9]
    Method
    		 Marginal model
    Confidence interval
    Notes
    [9] - Effect of treatment on the scores of Global health status

    Secondary: Pain scale influence scoring as per the standardized EORTC QLQ-C30 version 3 questionnaire

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    End point title
    		 Pain scale influence scoring as per the standardized EORTC QLQ-C30 version 3 questionnaire
    End point description
    Mean profiles of scales and items of the EORTC QLQ-C30 version 3 questionnaire display for each visit the mean ±1.96× standard error of the mean and the number of patients who completed the questionnaire. These profiles showed that mean scores of all items of the EORTC QLQ-C30 version 3 questionnaire were comparable in both treatment groups. A repeated measurement analysis was performed to investigate whether treatment, baseline score, time (i.e., visit), or interaction of treatment with time (visit) had an effect on the scores of the Pain scales. The baseline score and visit were the two factors having a statistically significant effect on the scores of the Pain scale (p = 0.0001 and p = 0.0140, respectively).
    End point type
    Secondary
    End point timeframe
    34 months after randomization
    End point values
    		 Immunotherapy group Control group
    Number of subjects analysed
    25 [10]
    22 [11]
    Units: Not applicable
        number (not applicable)
    0
    0
    Notes
    [10] - mITT
    [11] - mITT
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    A repeated measurement analysis was performed using a marginal model with a robust covariance matrix. As a response variable, the scores for “on-treatment” visits with more than 10 patients with an available score in either treatment group were included. As explanatory variables, terms for treatment, baseline score, time (i.e., visit), and an interaction for treatment and time were included.
    Comparison groups
    Immunotherapy group v Control group
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6089 [12]
    Method
    		 Marginal model
    Confidence interval
    Notes
    [12] - Effect of treatment on the scores of Pain scales

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events, serious adverse events: from the first dose of treatment to 30 days after the last dose of DCVAC/PCa (immunotherapy group) or completion/discontinuation of chemotherapy (control group) Deaths: from consent signature to trial termination
    Adverse event reporting additional description
    The tables include information on treatment-emergent adverse events, treatment-emergent serious adverse events, and all deaths. An event causally related to treatment was one which was assessed by investigators as causally related to DCVAC/PCa administration.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Immunotherapy group
    Reporting group description
    		 DCVAC/PCa in combination with chemotherapy

    Reporting group title
    Control group
    Reporting group description
    		 Chemotherapy alone

    Serious adverse events
    		 Immunotherapy group Control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 25 (40.00%)
    5 / 22 (22.73%)
         number of deaths (all causes)
    19
    14
         number of deaths resulting from adverse events
    1
    0
    Injury, poisoning and procedural complications
    Gastroenteritis radiation
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder obstruction
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Diabetic foot infection
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis superficial
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 22 (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
    		 Immunotherapy group Control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 25 (92.00%)
    21 / 22 (95.45%)
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    5 / 25 (20.00%)
    2 / 22 (9.09%)
         occurrences all number
    5
    2
    Paraesthesia
         subjects affected / exposed
    6 / 25 (24.00%)
    7 / 22 (31.82%)
         occurrences all number
    6
    7
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 25 (12.00%)
    3 / 22 (13.64%)
         occurrences all number
    3
    3
    Leukocytosis
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 22 (13.64%)
         occurrences all number
    1
    3
    Neutropenia
         subjects affected / exposed
    3 / 25 (12.00%)
    5 / 22 (22.73%)
         occurrences all number
    3
    5
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 22 (13.64%)
         occurrences all number
    1
    3
    Fatigue
         subjects affected / exposed
    10 / 25 (40.00%)
    5 / 22 (22.73%)
         occurrences all number
    10
    5
    Pyrexia
         subjects affected / exposed
    3 / 25 (12.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 25 (24.00%)
    7 / 22 (31.82%)
         occurrences all number
    6
    7
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 25 (12.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    Dyspnoea
         subjects affected / exposed
    2 / 25 (8.00%)
    3 / 22 (13.64%)
         occurrences all number
    2
    3
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    5 / 25 (20.00%)
    3 / 22 (13.64%)
         occurrences all number
    5
    3
    Hyperhidrosis
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 22 (4.55%)
         occurrences all number
    3
    1
    Nail dystrophy
         subjects affected / exposed
    4 / 25 (16.00%)
    0 / 22 (0.00%)
         occurrences all number
    4
    0
    Rash
         subjects affected / exposed
    1 / 25 (4.00%)
    4 / 22 (18.18%)
         occurrences all number
    1
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    5 / 25 (20.00%)
    1 / 22 (4.55%)
         occurrences all number
    5
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 25 (12.00%)
    3 / 22 (13.64%)
         occurrences all number
    3
    3
    Pain in extremity
         subjects affected / exposed
    3 / 25 (12.00%)
    2 / 22 (9.09%)
         occurrences all number
    3
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 25 (8.00%)
    3 / 22 (13.64%)
         occurrences all number
    2
    3
    Hyperglycaemia
         subjects affected / exposed
    5 / 25 (20.00%)
    3 / 22 (13.64%)
         occurrences all number
    5
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Dec 2011
    - European Pharminvent Services to be responsible for pharmacovigilance services - Added specifications of the assessments of leukapheresis feasibility (vein access evaluation) prior to the procedure for patients in the immunotherapy group - Specification for HIV tests added (CE-marked kits; accredited laboratory)
    11 Jun 2012
    - Prolongation of the time frame for leukapheresis and for leukapheresis feasibility assessment - Clarification of cyclophosphamide dosing - Clarification of ACI dosing - Highlighted synchronization of visits for both groups of patients - Modified exclusion criteria - Updated SAE reporting - Explanation added for not performing leukapheresis in the control group - Reasons for early termination of patient participation in the trial added - inability to perform leukapheresis or failure to manufacture ACI - ACI transport and application description updated - Prolonged sampling time frame for Immunology and Immunomonitoring to 6 months - Explanation added that missed ACI administration is not considered a reason for termination of patients’ participation in the trial
    11 Aug 2014
    - 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 the University Hospital Motol updated per current knowledge - Section on concomitant medication was updated - Updated safety reporting sections - New term introduction: End of the Treatment, End of Study, End of Study Examination visit, Follow-up and Survival Follow-up - Updated trial duration - Updated section Rationale for Prostate Cancer Immunotherapy - Terminology harmonization
    23 Jul 2015
    - Updated safety reporting sections to capture transfer of safety monitoring responsibilities from the European PharmInvent Services transferred to SOTIO a.s. as of 03-Jan-2015 - Implementation of the Pregnancy Data Collection Form and minor wording updates in the pharmacovigilance section - Wording for Exploratory Endpoints and Analysis was detailed

    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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