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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42572   clinical trials with a EudraCT protocol, of which   7010   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


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    Summary
    EudraCT Number:2012-000142-35
    Sponsor's Protocol Code Number:UC-0160/1105
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2016-08-18
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPortugal - INFARMED
    A.2EudraCT number2012-000142-35
    A.3Full title of the trial
    A prospective randomised phase III study of androgen deprivation therapy (+/- docetaxel) with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    _
    A.4.1Sponsor's protocol code numberUC-0160/1105
    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 SponsorUNICANCER
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJANSSEN-CILAG
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointClaire
    B.5.3 Address:
    B.5.3.1Street AddressJOUFFROY
    B.5.3.2Town/ cityParis cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number33171 93 63 66
    B.5.5Fax number33171 93 61 69
    B.5.6E-mailc-jouffroy@unicancer.fr
    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 Yes
    D.2.1.1.1Trade name Abiraterone Acetate
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABIRATERONE ACETATE
    D.3.9.1CAS number 154229-18-2
    D.3.9.3Other descriptive nameABIRATERONE ACETATE
    D.3.9.4EV Substance CodeSUB31647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 hormone-naïve prostate cancer
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    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
    To assess the efficacy of androgen deprivation therapy (+/- docetaxel) with or without local radiotherapy with or without abiraterone acetate and prednisone in terms of overall survival (OS) and progression-free survival (PFS) in patient with metastatic hormone-naïve prostate cancer.
    E.2.2Secondary objectives of the trial
    •PSA response rate
    •Prospective correlative study of PSA response/progression at 8 months
    •Radiological progression-free survival
    •Prostate cancer specific survival
    •Time to pain progression
    •Time to next skeletal-related event
    •Time to chemotherapy for CRPC
    •Time to severe local symptoms
    •Toxicity (with a specific focus on the use of long-term low-dose steroids)

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biologic ancillary study: constitution of a collection

    Imaging ancillary study
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed adenocarcinoma of the prostate,
    2. Metastatic disease documented by positive bone scan or CTscan or MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:
    o At least one extra-pelvic lymph node ≥ 2 cm
    or
    o extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm
    3. Patients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),
    4. Life expectancy of at least 6 months,
    5. Male aged ≥ 18 years old,
    6. Hemoglobin ≥ 10.0 g/dL,
    7. Platelet count ≥ 100,000/μL,
    8. Renal function: serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min,
    9. Serum potassium ≥ 4 mmol/L,
    10. Liver function: Serum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert’s disease); AST and ALT ≤ 2.5 x ULN (and ≤ 5 ULN in case of liver metastases),
    11. Patients might have received a maximum of 3 months of androgen deprivation therapy (ADT) before randomization,
    12. Patients might have received previous radiation therapy directed to bone lesions,
    13. Patients able to take oral medication,
    14. Patients who have received the information sheet and signed the informed consent form,
    15. Male patients who are receiving the study treatment and have partners of childbearing potential and/or pregnant partners are advised to use a method of birth control in addition to adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of the study treatment,
    16.Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
    17.Patients with a public or a private health insurance coverage, according to the local laws for partipation in clinical trials

    Additional criteria for patients receiving docetaxel
    18. Patients willing to receive docetaxel
    19. Neutrophil ≥ 1500 cells/mm3
    20. Liver function: AST and ALT ≤ 1.5 x ULN; ALP ≤ 2.5 x ULN; Serum bilirubin ≤ 1.5 x ULN.
    21. Male patients who will receive docetaxel and have partners of childbearing potential and/or pregnant partners are advised to use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 6 months after the last dose of docetaxel.
    E.4Principal exclusion criteria
    1. Patients with previous local treatment directed to the prostate primary cancer (radiotherapy, brachytherapy, radical prostatectomy, or other). A previous trans-urethral resection of the prostate (TURP) is allowed,
    2. Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate cancer,
    3. Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone twice daily,
    4. Active infection or other medical condition for which prednisone/prednisolone (corticosteroid) use would be contraindicated,
    5. Previously treated with ketoconazole for prostate cancer for more than 7 days,
    6. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of randomization,
    7. Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg),
    8. Patients with a history of hypertension that is not controlled by anti-hypertensive treatment,
    9. Severe hepatic impairment or moderate hepatic impairment (Child – Pugh class C or B)
    10. Active or symptomatic viral hepatitis or chronic liver disease (except Gilbert’s disease),
    11. History of pituitary or adrenal dysfunction,
    12. Pathological finding consistent with small cell carcinoma of the prostate,
    13. Clinically known significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline,
    14. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy,
    15. Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months,
    16. Known allergies, hypersensitivity or intolerance to the study drugs or excipients,
    17. Administration of an investigational therapeutic within 30 days of D1,
    18. Patients already included in another therapeutic trial involving an experimental drug,
    19. Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial. Those conditions should be discussed with the patient before registration in the trial,
    20. Individual deprived of liberty or placed under the authority of a tutor.


    Additionnal criteria for patients receiving docetaxel:
    21. Patients with impaired vision should undergo a prompt and complete ophtalmologic examination. In case of Cystoid Macular Oeadema, the patient should not receive docetaxel.
    22. Concomitant use of strong CYP3A4 inhibitors ( clarithromyin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin)
    23. Allergy to taxane
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of this study are overall survival (OS) and CRPC progression-free survival (PFS).
    Overall survival (OS) is defined as the time from randomization to the time of death from any cause and progression-free survival (PFS) is defined as the time from randomization to the castrate-resistant stage or death of any cause.
    CRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).
    A PSA rise is defined by an increased serum PSA on 2 different measurements, confirmed on a third measurement (measurement A<B<C). The minimum level of the third PSA measurement should be 0.5 ng/mL.
    E.5.1.1Timepoint(s) of evaluation of this end point
    _
    E.5.2Secondary end point(s)
    •PSA response rate will be defined by an undetectable serum PSA level at 8 months (after initiation of ADT),
    •The prospective correlative study of PSA response/progression will be evaluate at 8 months after initiation of ADT,
    •The radiological progression-free survival will be defined by RECIST criteria v1.1 or by the appearance of at least 2 new bone metastases on bone scan according to modified PCWG2 criteria or death,
    •The prostate cancer-specific survival will be calculated from the date of randomization to the date of the death due to prostate cancer,
    •The time to pain progression will be evaluated by questionnaires,
    •The time to next skeletal-related event will be defined by even a fracture or bone pain requiring radiation therapy or spinal cord compression or preventive surgery to the bones. Events will be evaluated by investigators. No systematic X-Ray will be perform,
    •The time to chemotherapy will be calculated from the date of randomization to the date of the introduction of chemotherapy treatment for CRPC,
    •The time to severe local symptoms (grade 3 and 4 events) related to tumor progression and/or radiotherapy long term side effets will be evaluated according to NCI-CTCAE v4.0,
    •The impact of the radiotherapy protocol on outcome (PFS and local symptoms),
    •Toxicity (with a specific focus on the use of long-term low-dose steroids) will be evaluated according to NCI-CTCAE v4.0,
    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 Yes
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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.8.2.3.1Comparator description
    androgen deprivation therapy with or without local radiotherapy with or without abiraterone acetate
    E.8.2.4Number of treatment arms in the trial4
    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 concerned50
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years10
    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: 458
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 458
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 916
    F.4.2.2In the whole clinical trial 916
    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)
    None
    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 Decision2016-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-03
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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