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    Summary
    EudraCT Number:2013-004711-50
    Sponsor's Protocol Code Number:9785-MA-1001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-22
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-004711-50
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in
    Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated with Docetaxel plus Prednisolone Who Have Progressed on Enzalutamide Alone
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the benefit of treatment beyond progression with enzalutamide in men who are starting treatment with docetaxel after worsening of their prostate cancer when taking enzalutamide alone
    A.3.2Name or abbreviated title of the trial where available
    PRESIDE
    A.4.1Sponsor's protocol code number9785-MA-1001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02288247
    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 SponsorAstellas Pharma Europe Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportAstellas Pharma Europe Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointMary Mantock
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715455133
    B.5.5Fax number+31715455501
    B.5.6E-mailmary.mantock@astellas.com
    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 Xtandi
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Capsule, soft
    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 INNENZALUTAMIDE
    D.3.9.1CAS number 915087-33-1
    D.3.9.4EV Substance CodeSUB77412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    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
    E.1.1.1Medical condition in easily understood language
    Prostate Cancer that has spread despite testosterone-lowering treatments
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 compare the efficacy of continuing treatment with enzalutamide after adding docetaxel and prednisolone versus placebo plus docetaxel and prednisolone, as measured by progression-free survival (PFS) in subjects with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) with progression during treatment with enzalutamide alone
    E.2.2Secondary objectives of the trial
    To evaluate the effect of continuing treatment with enzalutamide after adding docetaxel and prednisolone versus placebo plus docetaxel and prednisolone, as measured by the following in subjects with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) with progression during treatment with enzalutamide alone:
    - Time to prostate-specific antigen (PSA) progression;
    - PSA response;
    - Objective response rate;
    - Time to pain progression;
    - Time to opiate use for cancer-related pain;
    - Time to first skeletal-related event;
    - Quality of life.
    Safety profile including cumulative dose of docetaxel and Health Resource Use will be described for these subjects.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biomarker Sub-study:
    - Subjects in a subset of countries and sites will be invited to participate in a voluntary, exploratory, biomarker sub-study. For subjects who have consented to provide samples for this sub-study, blood samples for circulating biomarker analysis will be taken at the following timepoints:

    - Period 1: Week 1/Day 1 (pre dosing with enzalutamide), Week 5, Week 13, and when subjects progress clinically (4 samples).
    - Period 2: Week 1/Day 1 (pre study drug in Period 2), Cycle 2 (Week 4), Cycle 5 (Week 13), Cycle 9 (Week 25), when subjects progress clinically or reach another endpoint in the study and at Follow-Up (30 days after last dose of IMP) (6 samples).

    - Any subject who consents to participate in the biomarker sub-study, but fails to provide a valid baseline sample for Period 1, may still participate in Period 2 of the biomarker sub-study. In this case, the last sample of Period 1 (the sample taken when they progress clinically) should be taken as part of the baseline for Period 2. Informed Consent for the biomarker samples must be taken before any samples are collected. Samples are to be handled according to the laboratory manual, and shipped to a central laboratory for processing.
    E.3Principal inclusion criteria
    1. Age 18 or older;
    2. Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable);
    3. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;
    4. Ongoing ADT with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist at a stable dose and schedule within 4 weeks of initiation of IMP, or bilateral orchiectomy (i.e., surgical or medical castration);
    5. Serum testosterone level ? 1.73 nmol/L (? 50 ng/dL);
    6. Metastatic (M1) disease documented by at least 2 bone lesions on bone scan, or soft tissue disease documented by CT/MRI;
    7. Progressive disease at study entry defined as the following occurring in the setting of castrate levels of testosterone: PSA progression defined by a minimum of three rising PSA levels with an interval of ? 1 week between each determination. The PSA value at Screening should be ? 2 ?g/L (? 2 ng/mL). In the event of prior androgen receptor inhibitor use, the most recent local PSA and the Screening PSA assessed by the central laboratory (central PSA) must be obtained at least 4 weeks after the last dose of androgen receptor inhibitor;
    8. Asymptomatic or minimally symptomatic prostate cancer (BPI SF question 3 score of < 4) at Screening;
    9. ECOG performance score of 0-1 at Screening;
    10. Estimated life expectancy of ? 12 months from Screening;
    11. Be suitable and willing to receive chemotherapy as part of the trial;
    12. Able to swallow the IMP and comply with study requirements;
    13. Subjects and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control* (one of which must be a condom) starting at Screening and continue throughout the study period and for 3 months after the final IMP administration;
    14. Subjects must not donate sperm starting at Screening and throughout the study period and for 3 months after the final IMP administration. A condom is required throughout the study period and for 3 months after the final IMP administration if the subject is engaged in sexual activity with a pregnant woman;
    15. Subject agrees not to participate in another interventional study while on treatment. Subjects who are participating in a control arm of an interventional study which includes only standard of care, or in an observational phase following an interventional study, may be eligible for this study, providing they meet all the other entry criteria
    E.4Principal exclusion criteria
    1. Absolute neutrophil count (ANC) < 1,500/?L, platelet count < 100,000/?L, or hemoglobin < 6.2 mmol/L (< 10 g/dL)
    (NOTE: subjects must not have received any growth factors or blood transfusions within seven days prior to the hematologic laboratory values obtained at Screening);
    2. Total bilirubin > upper limit of normal (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ? 2.5 times ULN; Child-Pugh B and C hepatic impairment;
    3. Creatinine > 177 ?mol/L (> 2 mg/dL);
    4. Albumin ? 30 g/L (? 3.0 g/dL;
    5. Prior treatment with the following agents for the treatment of prostate cancer: Aminoglutethimide; Ketoconazole; Abiraterone; Enzalutamide or participation in a clinical trial of enzalutamide; 223Ra, 89Sr, 153Sm, 186Re/188Re; Immunomodulatory therapies (e.g. Sipuleucel-T, DCVAC); Cytotoxic chemotherapy (e.g. docetaxel, cabazitaxel, mitoxantrone, estramustine); Participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (e.g. ARN-509, ODM-201, VT-464; unless the treatment was placebo);
    6. Current or prior treatment within 4 weeks prior to initiation of IMP with the following agents for the treatment of prostate cancer: Antiandrogens (e.g., bicalutamide, nilutamide, flutamide); 5-? reductase inhibitors (e.g., finasteride, dutasteride); Estrogens; Anabolic steroids; Drugs with antiandrogenic properties such as spironolactone > 50 mg/kg; Progestational agents;
    7. Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to initiation of IMP;
    8. Use of opiate analgesia for pain from prostate cancer within 4 weeks prior to initiation of IMP;
    9. Radiation therapy to bone lesions or prostatic bed within 4 weeks prior to initiation of IMP;
    10. Major surgery within 4 weeks prior to initiation of IMP;
    11. History of seizure or any condition that may predispose to seizures at any time in the past (e.g., prior cortical stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization). History of loss of consciousness or transient ischemic attack within 12 months prior to Screening;
    12. Known or suspected brain metastasis or active leptomeningeal disease;
    13. History of another malignancy within the previous 5 years other than non-melanoma skin cancer;
    14. Clinically significant cardiovascular disease including: Myocardial infarction within six months prior to Screening; Uncontrolled angina within three months prior to Screening; Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ? 45%; History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes); History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place; Bradycardia as indicated by a heart rate < 45 beats per minute on the screening ECG or physical examination; Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at Screening;
    15. Gastrointestinal disorders affecting absorption (e.g., extensive small bowel resection, active inflammatory bowel disease);
    16. Medical contraindications to the use of prednisolone or docetaxel;
    17. Allergies to any of the active ingredients or excipients in the study drugs;
    18. Any condition which, in the Investigator's opinion, makes the subject unsuitable for study participation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is PFS with progression defined as radiographic progression, unequivocal clinical progression, or death.
    PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression, unequivocal clinical progression, or death on study, whichever occurs first.
    - Radiographic disease progression is defined for bone disease by the appearance of 2 or more new lesions on whole-body radionuclide bone scan per PCWG2 criteria or for soft tissue disease by RECIST 1.1;
    - Unequivocal clinical progression is defined as any of the following:
    - new onset cancer pain requiring chronic administration of opiate analgesic medication;
    - deterioration from prostate cancer of ECOG performance status score to 3 or higher;
    - initiation of cytotoxic chemotherapy or radiation therapy or surgical intervention due to complications of tumor progression. Radiotherapy for palliative management of symptoms due to prostate cancer will not be considered unequivocal clinical progression;
    - Death on study is defined as death within 112 days of treatment discontinuation without objective evidence of radiographic progression.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from randomization to the earliest objective evidence of radiographic progression, unequivocal clinical progression, or death on study, whichever occurs first.
    - Imaging is assessed every 12 weeks
    - Clinical progression endpoints will be assessed at each clinical visit (every 3 weeks during docetaxel dosing, every 12 weeks thereafter)
    E.5.2Secondary end point(s)
    - Time to PSA progression, defined as the time from randomization to the date of the first PSA value in Period 2 demonstrating progression (Period 2). The PSA progression date is defined as the date that a ? 25% increase and an absolute increase of ? 2 ng/mL above the nadir recorded in Period 2 is documented, which must be confirmed by a second consecutive value obtained at least 3 weeks later;
    - PSA response, defined as the percentage change in PSA from randomization to Week 13 (or earlier for those that discontinue therapy), as well as the maximum decline in PSA that occurs at any point after treatment;
    - Objective response rate, defined as the best overall radiographic response after randomization as per Investigator assessments of response for soft tissue disease per RECIST 1.1, in subjects who have a measurable tumor;
    - Time to pain progression, defined as the time to an increase of ? 30% from randomization in the mean of BPI-SF pain intensity item scores (items 3, 4, 5, and 6);
    - Time to opiate use for cancer-related pain, defined as the time to initiation of chronic administration of opiate analgesia;
    - Time to first SRE, defined as the time from randomization to radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain;
    - Quality of life, as assessed using FACT-P and EQ-5D-5L.
    Other Endpoints:
    - Cumulative dose of docetaxel.
    - Health resource use (hospitalization and duration thereof; number and types of visits to a health
    professional) in Period 1 and Period 2
    Exploratory Endpoints:
    - To analyze candidate biomarkers in circulation for association with response or progression and for identifying mechanisms of resistance.
    Safety Endpoints:
    - Safety in both Periods will be assessed by AEs, clinically significant changes in physical examination, vital signs, laboratory values, and ECGs.
    - Deaths, defined as deaths due to any cause, will be summarized descriptively.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Imaging is assessed every 12 weeks
    - Clinical endpoints will be assessed at each clinical visit (every 3 weeks during docetaxel dosing, every 12 weeks thereafter)
    - Quality of Life endpoints will be assessed every 12 weeks
    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 No
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Two Periods; Period 1 open-label active treatment; Period 2 double-blind randomized treatment
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA83
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Czech Republic
    France
    Germany
    Greece
    Italy
    Netherlands
    Norway
    Poland
    Russian Federation
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    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 years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 175
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 475
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 615
    F.4.2.2In the whole clinical trial 650
    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)
    Patients completing the study or discontinuing the study early will move to standard of care clinical management as directed by their treating doctor.

    Extension Period 1 and 2 have been added to allow continuation of open-label enzalutamide treatment for subjects still in Period 1 when enrollment to Period 2 is completed and of double-blind treatment for any subjects still in Period 2 when the required number of endpoint events (182) is reached (the cut-off for data analysis).
    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 Decision2015-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-30
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