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    The EU Clinical Trials Register currently displays   38179   clinical trials with a EudraCT protocol, of which   6271   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2011-004735-32
    Sponsor's Protocol Code Number:SP001
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-21
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedCzech Republic - SUKL
    A.2EudraCT number2011-004735-32
    A.3Full title of the trial
    Randomized, open-label, parallel-group, multi-centre phase II clinical trial with active cellular immunotherapy DCVAC/PCa in patients with castrate-resistant prostate cancer
    Randomizovaná, otevřená, multicentrická klinická studie fáze II s paralelními skupinami u pacientů s kastračně-rezistentním karcinomem prostaty léčených pomocí aktivní buněčné imunoterapie přípravkem DCVAC/PCa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, open-label, parallel-group, multi-centre phase II clinical trial with active cellular immunotherapy DCVAC/PCa in patients with castrate-resistant prostate cancer
    A.3.2Name or abbreviated title of the trial where available
    not applicable
    A.4.1Sponsor's protocol code numberSP001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSOTIO a.s.
    B.1.3.4CountryCzech Republic
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSOTIO a.s.
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSOTIO a.s.
    B.5.2Functional name of contact pointClinical Trials Sotio
    B.5.3 Address:
    B.5.3.1Street AddressJankovcova 1518/2
    B.5.3.2Town/ cityPraha 7 - Holešovice
    B.5.3.3Post code170 00
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420224175111
    B.5.5Fax number+420227204958
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDCVAC/PCa
    D.3.2Product code DCVAC/PCa
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDCVAC/PCa
    D.3.9.1CAS number DCVAC/PCa
    D.3.9.2Current sponsor codeDCVAC/PCa
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D. cell therapy medicinal product Yes
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    metastatic castrate-resistant prostate cancer
    metastazující kastračně rezistentní karcinom prostaty
    E.1.1.1Medical condition in easily understood language
    metastatic castrate-resistant prostate cancer
    metastazující kastračně rezistentní karcinom prostaty
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The clinical trial’s objective is to estimate the survival rate of patients 34 months after randomization, estimate the proportion of patients without progression 34 months after randomization, evaluate quality of life and the influence on the pain scale scoring using the standardized EORTC QLQ-C30 (version 3.0) questionnaire and the incidence of adverse events.

    An exploratory objective is to search for potential biomarkers that could play a role as prognostic factors, indicate the biological effect of ACI on the immune-reponse or identify a subgroup of patients profiting from cancer immunotherapy based on gene expression profiling.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I-1) Men aged ≥ 18 years
    I-2) Histologically confirmed prostate cancer
    I-3) Presence of metastatic bone disease according to at least one of the following modalities: bone scan (scintigraphy, PET-CT), confirmed pathological fracture, evidence of bone metastases confirmed by MRI or CT
    I-4) Presence of progression defined as at least one of the following:
    I-4a) PSA level increasing by at least 2 ng/mL at an interval of at least 14 days with an absolute value ≥ 5 ng/mL and ≥ 50% above the PSA minimum reached during the ADT (androgen deprivation therapy) or above the level prior to treatment, if there was no response.
    I-4b) Two or more new lesions discovered on the bone scan or CT or MRI as compared with the preceding scan
    I-5) Continuing castrate condition: Patients who did not undergo surgical orchiectomy have to continue hormone drug therapy (GnRH/LHRH analogs) to maintain the castrate level of serum testosterone ≤ 1.7 nmol/l (50 ng/dl). The castrate condition has to be at least 3 months before enrolment to the study and continue for the study duration.
    I-6) The following laboratory values: WBC > 4 x 10(9)/L, ANC ≥ 1.5x 10(9)/L, platelet count > 100 x 10(9)/L, Hb ≥ 90 g/L, Hct > 30%, Creatinine under 1.5 times the upper limit of normal, bilirubin, AST and ALT under 1.5 times the upper limit of normal.
    I-7) ECOG 0-2 Performance Status
    I-8) Signed informed consent to participate in the study
    I-9) Recovery from primary local surgery, radiotherapy or orchiectomy.
    I-10) At least 8 weeks from radioisotope therapy (Samarium-153, Strontium -89 or similar)
    E.4Principal exclusion criteria
    E-1) Sexually active fertile men not using effective birth control, if their partners are of fertile age and of child-bearing potential
    E-2) Comorbidities of the patient
    E-2a) HIV-positive
    E-2b) Active hepatitis B or C
    E-2c) Active bacterial, viral or mycotic infection requiring systemic treatment
    E-2d) Clinically significant cardiovascular disease, including myocardial infarction or ventricular tachyarrhythmia in previous 6 months, percutaneous coronary intervention or surgical revascularization in the past 6 months, heart failure NYHA II-IV, known left ventricular dysfunction with ejection fraction < 40% or haemodynamically significant arrhythmias or conduction problems, unless treated with permanent cardiac pacing.
    E-2e) Pleural or pericardial effusion of any CTC grade
    E-2f) Peripheral neuropathy CTC Grade ≥ 2.
    E-2g) Other uncontrolled coexisting condition, uncompensated psychiatric illness or social situation that would limit patient’s compliance.
    E-2h) Patients with a history of malignancy other than non-melanoma skin cancer.
    E-2i) Unresolved ongoing urinary tract obstruction
    E-2j) Active autoimmune disease requiring therapy
    E-2k) History of primary immunodeficiency
    E-3) Allergy and adverse drug reactions
    E-3a) History of allergic reaction to a compound of the same or similar structure as medication used in this study.
    E-3b) History of anaphylaxis or other severe reaction following vaccination
    E-4) Any other serious reason the Investigator considers the patient should not participate in the study
    E-5) Patients already treated with chemotherapy for prostate cancer (except estramustine)
    E-6) Patients with brain and leptomeningeal metastases
    E-7) Participation in another clinical trial or administration of another investigational medicinal product within 30 days preceding the screening
    E-8) Treatment with antiandrogens, inhibitors of adrenal androgen production, or any other anti-tumor hormone therapy ongoing on the day of screening or in preceding 4 weeks except GnRH/LHRH analogs
    E-9) Immunotherapy other than specified in this protocol
    E.5 End points
    E.5.1Primary end point(s)
    • The survival rate of patients 34 months after randomization.
    E.5.1.1Timepoint(s) of evaluation of this end point
    E.5.2Secondary end point(s)
    •The survival rate of patients without disease progression and without PSA progression 34 months after randomization
    •The survival rate of patients without disease progression 34 months after randomization
    •Incidence of adverse events
    •Quality of life as per standardized EORTC QLQ-C30 questionnaire, version 3, European Organization for Research and Treatment of Cancer
    •Pain scale influence scoring as per standardized EORTC QLQ-C30 questionnaire version 3, European Organization for Research and Treatment of Cancer

    Exploratory endpoints
    •Immune response
    •Gene expression profiling, and/or expression levels of a defined set of immune or cancer-related genes, respectively
    E.5.2.1Timepoint(s) of evaluation of this end point
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    Patient group receiving only standard of care chemotherapy
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned13
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study will be terminated by the Sponsor as soon as the last surviving study patient undergoes the follow-up visit 24 months after the end of treatment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    not applicable
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-20
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