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    The EU Clinical Trials Register currently displays   37701   clinical trials with a EudraCT protocol, of which   6178   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2015-002590-38
    Sponsor's Protocol Code Number:17777
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-14
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-002590-38
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled Phase III study of darolutamide (ODM-201) versus placebo in addition to standard androgen deprivation therapy and docetaxel in patients with metastatic hormone-sensitive prostate cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Darolutamide in addition to standard hormone therapy and docetaxel in metastatic hormone-sensitive prostate cancer
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number17777
    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 SponsorBayer AG
    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 supportBayer AG
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.4Telephone number004930300139003
    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 nameDarolutamide 300mg film-coated tablet
    D.3.2Product code BAY 1841788 300mg film-coated tablet
    D.3.4Pharmaceutical form Film-coated 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 INNBAY 1841788
    D.3.9.1CAS number 1297538-32-9
    D.3.9.2Current sponsor codeDarolutamide
    D.3.9.3Other descriptive nameBAY 1841788
    D.3.9.4EV Substance CodeSUB71144
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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. cell therapy medicinal product No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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 hormone-sensitive prostate cancer (mHSPC)
    E.1.1.1Medical condition in easily understood language
    Prostate cancer which does respond to hormonal treatment
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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 demonstrate the superiority in overall survival of darolutamide in addition to standard androgen deprivation therapy (ADT) and docetaxel over placebo in addition to standard ADT and docetaxel
    E.2.2Secondary objectives of the trial
    • Time to castration-resistant prostate cancer
    • Time to initiation of subsequent antineoplastic therapy
    • Symptomatic skeletal event free survival (SSE-FS)
    • Time to first symptomatic skeletal event (SSE)
    • Time to initiation of opioid use for ≥7 consecutive days
    • Time to pain progression
    • Time to worsening of physical symptoms of disease based on Functional assessment of cancer therapy / National Comprehensive Cancer Network prostate cancer symptom index 17 (NCCN-FACT FPSI-17)
    • Safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet the following criteria at the time of Screening:
    1. Written informed consent.
    2. Males ≥18 years of age.
    3. Histologically or cytologically confirmed adenocarcinoma of prostate.
    4. Metastatic disease documented either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by Investigator and confirmed by central radiology review. Metastatic disease is defined as either malignant lesions in bone scan or measurable lymph nodes above the aortic bifurcation or soft tissue/visceral lesions according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Lymph nodes are measurable if the short axis diameter is ≥15 mm, soft tissue/visceral lesions are measurable if the long axis diameter is ≥10 mm.
    • Subjects with regional lymph node metastases only (N1, below the aortic bifurcation) will not be eligible for the study. Only subjects with non-regional lymph node metastases (M1a) and/or bone metastases (M1b) and/or other sites of metastases with or without bone disease (M1c) will be eligible.
    5. Subjects must be candidates for ADT and docetaxel therapy per Investigator’s judgment.
    6. Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but no longer than 12 weeks before randomization. For subjects receiving LHRH agonists, treatment in combination with a first generation anti-androgen for at least 4 weeks prior to randomization is recommended. First generation anti-androgen has to be stopped prior to randomization.
    7. An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
    8. Blood counts at Screening: hemoglobin ≥9.0 g/dL, absolute neutrophil count ≥1.5x109/L, platelet count ≥100x109/L (subject must not have received any growth factor within 4 weeks or a blood transfusion within 7 days of the hematology laboratory sample obtained at Screening).
    9. Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤1.5 x upper limit of normal (ULN), total bilirubin ≤ULN, creatinine ≤2.0 x ULN.
    10. Sexually active male subjects must agree to use condoms as an effective barrier method and refrain from sperm donation, and their female partners of reproductive potential to use a method of effective birth control. Sterilized male participants will also need to use an additional contraception form.
    Any of the contraception methods described below should be used during the treatment with darolutamide/placebo and for 3 months after treatment with darolutamide/placebo and 6 months after treatment with docetaxel:
    · Barrier (e.g. condom) or double-barrier methods of contraception (e.g. condom with occlusive cap), only if used with spermicidal foam/gel/film/cream/suppository
    · Intrauterine contraceptive device (female partners)
    · Intrauterine hormone-releasing system (female partners)
    · Approved pharmaceutical contraceptive products for female partners (e.g., birth control pills or patches, long-term injectable or implantable hormonal contraceptive)
    E.4Principal exclusion criteria
    Subjects who meet any of the following criteria at the time of Screening will be excluded:
    1. Prior treatment with:
    • LHRH agonist/antagonists started more than 12 weeks before randomization
    • Second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide, other investigational AR inhibitors
    • Cytochrome P 17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer
    • Chemotherapy or immunotherapy for prostate cancer prior to randomization
    2. Treatment with radiotherapy (external beam radiation therapy [EBRT], brachytherapy, or radiopharmaceuticals) within 2 weeks before randomization.
    3. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs.
    4. Contraindication to both CT and MRI contrast agent.
    5. Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV).
    6. Uncontrolled hypertension as indicated by a resting systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg despite medical management.
    7. Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed ≥5 years before randomization and from which the subject has been disease-free.
    8. A gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study drug.
    9. An active viral hepatitis, known human immunodeficiency virus infection with detectable viral load, or chronic liver disease with a need of treatment.
    10. Previous (within 28 days before the start of study drug or 5 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s).
    11. Any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject’s participation in the study or evaluation of the study results.
    12. Inability to swallow oral medications.
    13. Close affiliation with the investigational site (e.g., a close relative of the Investigator, dependent person [e.g., employee or student of the investigational site]).
    14. Previous assignment to treatment in this study.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival, defined as the time (in days) from date of randomization until death from any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis will be performed when approximately 509 deaths occur in the 2 treatment arms combined. The expected study duration for 509 deaths is approximately 70 months.
    E.5.2Secondary end point(s)
    • Time to castration-resistant prostate cancer
    • Time to initiation of subsequent antineoplastic therapy
    • Symptomatic skeletal event free survival (SSE-FS)
    • Time to first symptomatic skeletal event (SSE)
    • Time to initiation of opioid use for ≥7 consecutive days
    • Time to pain progression
    • Time to worsening of physical symptoms of disease based on NCCN-FACT FPSI-17
    • Safety
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Time to PSA progression with serum testosterone being at castrate level <0.50 ng/mL,or the time to progression by soft tissue lesions or time to progression by bone lesions
    •Time from randomization to initiation of first subsequent antineoplastic therapy for prostate cancer
    •Time from randomization to the first occurrence of SSE or death from any cause
    •Time from randomization to the first occurrence of SSE
    •Time from date of randomization to the date of first opiate use for ≥7 consecutive days
    •Interval from randomization to the first date a subject experiences a pain progression
    •Interval from randomization to the first date a subject experiences an increase in physical symptoms based on the NCCN FACT FPSI 17 questionnaire
    •Refer to protocol section 10.3.3 for safety variables
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Overall survival
    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) 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 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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA105
    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
    Czech Republic
    Korea, Republic of
    Russian Federation
    United Kingdom
    United States
    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
    The study will end when all subjects on darolutamide treatment have
    transitioned into a separate program to continue receiving
    darolutamide (see protocol Section 8.2) or have discontinued the study
    for any other reason, and all subjects on placebo have discontinued
    Until transition to the separate program, subjects on darolutamide
    treatment will continue to follow all the protocol required procedures
    and visits in the current protocol.
    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 months6
    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 months9
    E.8.9.2In all countries concerned by the trial days25
    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: 650
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 650
    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 Yes
    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 Yes
    F. of subjects incapable of giving consent
    Verbal statement of consent can be given in the presence of impartial witness (independent of Sponsor and Investigator). To be documented by signature from informing physician and from witness.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 527
    F.4.2.2In the whole clinical trial 1300
    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)
    After treatment discontinuation, subjects will enter the Active Follow-up period and then the Long-term (Survival) Follow-up period. Therapy after discontinuation of treatment is detailed in section 8.2 ‘post study-therapy’ of the protocol.
    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 Decision2016-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-14
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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