Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36793   clinical trials with a EudraCT protocol, of which   6076   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-001746-34
    Sponsor's Protocol Code Number:56021927PCR3011
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-001746-34
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy
    Estudio fase III, aleatorizado, doble ciego y controlado con placebo sobre el uso de apalutamida en pacientes con cáncer de próstata de alto riesgo, localizado o localmente avanzado candidatos a una prostatectomía radical.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of androgen deprivation therapy (ADT) plus apalutamide (with or without abiraterone acetate with prednisone/prednisolone [AAP]) in patients with prostate cancer
    Un estudio de terapia de deprivación androgénica (TDA) más apalutamida (con o sin acetato de abiraterona más prednisona (AAP)) en pacientes con cáncer de próstata.
    A.3.2Name or abbreviated title of the trial where available
    PROTEUS
    PROTEUS
    A.4.1Sponsor's protocol code number56021927PCR3011
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Cilag S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917228630
    B.5.5Fax number+34917228628
    B.5.6E-mailmsanchez@its.jnj.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 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 nameApalutamide
    D.3.2Product code JNJ-56021927
    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 INNApalutamide
    D.3.9.1CAS number 956104-40-8
    D.3.9.2Current sponsor codeJNJ-56021927-AAA
    D.3.9.3Other descriptive nameAPALUTAMIDE
    D.3.9.4EV Substance CodeSUB127215
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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.IMP: 2
    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 nameTablet
    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 INNAbiraterone Acetate
    D.3.9.1CAS number 154229-18-2
    D.3.9.2Current sponsor codeJNJ-212082-AAA
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNApalutamide
    D.3.9.1CAS number 956104-40-8
    D.3.9.2Current sponsor codeJNJ-56021927-AAA
    D.3.9.3Other descriptive nameApalutamide
    D.3.9.4EV Substance CodeSUB127215
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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.IMP: 3
    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 Prednison acis
    D.2.1.1.2Name of the Marketing Authorisation holderacis Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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
    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 INNPredisone
    D.3.9.3Other descriptive namePredisone
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    High-risk localized or locally advanced prostate cancer
    Cáncer de próstata de alto riesgo localizado o localmente avanzado
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    Cáncer de próstata
    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 10060862
    E.1.2Term Prostate cancer
    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 determine if treatment with ADT plus apalutamide (with or without AAP) before and after radical prostatectomy in subjects with high-risk localized or locally advanced prostate cancer results in an improvement in pCR rate and MFS, as compared to ADT plus placebo
    - Determinar si el tratamiento con terapia de deprivación androgénica (TDA) más apalutamida (con o sin acetato de abiraterona y prednisona —AAP—) antes y después de una prostatectomía radical en pacientes con cáncer de próstata de alto riesgo localizado o localmente avanzado genera una mejoría en la tasa de respuesta patológica completa (RpC) y de la supervivencia libre de metástasis (SLM) en comparación con el tratamiento con TDA más placebo
    E.2.2Secondary objectives of the trial
    -To determine if treatment with ADT plus apalutamide (with or without AAP) before and after radical prostatectomy in subjects with high risk localized or locally advanced prostate cancer results in improvement of other efficacy endpoints, as compared to ADT plus placebo

    - To characterize the safety profile of treatment with ADT plus apalutamide (with or without AAP) before and after radical prostatectomy in subjects with high risk localized or locally advanced prostate cancer
    -Determinar si el TDA más apalutamida (con o sin AAP) antes y después de una prostatectomía radical en pacientes con cáncer de próstata de alto riesgo localizado o localmente avanzado genera una mejoría en otros criterios de valoración de la eficacia en comparación con el TDA más placebo

    - Caracterizar el perfil de seguridad del TDA más apalutamida (con o sin AAP) antes y después de una prostatectomía radical en pacientes con cáncer de próstata de alto riesgo localizado o localmente avanzado
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must be ≥18 years of age
    2. Signed an informed consent form (ICF) indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study; subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol (Section 4.3)
    3. Histologically confirmed adenocarcinoma of the prostate
    4. High risk defined by ≥1 of the following 4 criteria:
    • Any combination of Gleason score 4+3 and 4+4 from ≥6 systematic cores
    • Any combination of Gleason score 4+3 and 4+4 from ≥3 systematic cores and PSA ≥20 ng/mL
    • Gleason score ≥9 in at least one systematic or targeted core
    • At least 2 systematic or targeted cores with continuous Gleason score ≥8, each with ≥ 80% involvement
    5. Candidate for radical prostatectomy as per the investigator
    6. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
    7. Adequate organ function determined by the following central laboratory values:
    a. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin less than the upper limit of normal (ULN; note that in subjects with Gilbert’s syndrome, if total bilirubin is >1.5 X ULN, measure direct and indirect bilirubin. If direct bilirubin is ≤1.5 X ULN, the subject may be eligible)
    b. Serum creatinine <1.5 mg/dL
    c. Platelets ≥75,000/uL, without transfusion and/or growth factors within 1 month prior to randomization
    d. Hemoglobin ≥12.0 g/dL (7.4 mmol), without transfusion and/or growth factors within 1 month prior to randomization
    8. Able to receive ADT for up to 1 year, per the investigator’s assessment
    9. Be able to swallow whole study drug tablets and capsules
    10. Contraceptive (birth control) use by men (or female partners of men enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies.
    1. Pacientes con al menos 18 años de edad.

    2. El paciente debe haber firmado un documento de consentimiento informado indicando que comprende el objetivo y los procedimientos necesarios para el estudio y acepta participar en él; los pacientes deben aceptar y ser capaces de cumplir con las prohibiciones y restricciones especificadas en este protocolo (sección 4.3)

    3. Diagnóstico histológico confirmado de adenocarcinoma de próstata

    4. Enfermedad de alto riesgo definida por al menos 1 de los 4 siguientes
    criterios:
    -Cualquier combinación de Gleason 4 más 3 y 4 más 4 en al menos 6 cilindros sistemáticos
    -Cualquier combinación de Gleason 4 más 4 y 4 más 4 en al menos 3 cilindros sistemáticos y un PSA mayor o igual a 20 ng/ml
    -Gleason igual o mayor a 9 en al menos 1 cilindro sistemático o principal
    -Al menos dos cilindros sistemáticos o principales con una afectación contínua de Gleason mayor o igual a 8 con al menos un 80 por ciento de afectación

    5. Pacientes candidatos a prostatectomía radical a criterio del investigador

    6. ECOG de 0 o 1

    7. Adecuada función orgánica definida por los siguientes valores de laboratorio central:
    A. Aspartato aminotransferasa (AST), alanino aminotransferasa (ALT) y bilirrubina total inferior al límite superior normal (nótese que en pacientes con síndrome de Gilbert si la bilirrubina total es 1,5 por el límite superior normal de medida directa e indirecta de bilirrubina no se podrá incluir al paciente, mientras que si la bilirrubina directa es menor o igual a 1,5x el límite superior normal el paciente podrá ser incluido)
    B. Creatinina sérica menor a 1,5 mg/dl
    C. Plaquetas mayor o igual a 75000/uL sin transfusión ni factores de crecimiento en al menos un mes antes de la randomización
    D. Hemoglobina mayor o igual a 12 g/dl (7.4 mmol) sin transfusión ni factores de crecimiento en al menos un mes antes de la randomización

    8. El paciente debe ser capaz de recibir terapia de deprivación androgénica (TDA) al menos un año a criterio del investigador

    9. El paciente debe ser capaz de ingerir las pastillas y cápsulas completas del estudio

    10. El paciente debe tomar medidas anticonceptivas (o las parejas femeninas de pacientes incluídos en el estudio con potencial de dar el pecho o quedar embarazadas) acorde a la legislación local sobre métodos anticonceptivos aceptables para la participación en ensayos clínicos
    E.4Principal exclusion criteria
    1. Distant metastasis (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Patients are considered eligible only if the central radiological review confirms clinical stage M0
    2. Prior treatment with anti-androgen
    3. Prior treatment for prostate cancer
    4. Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
    5. Bilateral orchiectomy
    6. History of any pelvic radiation
    7. Use of any investigational agent ≤4 weeks prior to randomization
    8. Major surgery ≤4 weeks prior to randomization
    9. Any of the following within 6 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary
    10. Human immunodeficiency virus-positive subjects with 1 or more of the following:
    a. Not receiving highly active antiretroviral therapy
    b. Had a change in antiretroviral therapy within 6 months of the start of screening
    c. Receiving antiretroviral therapy that may interfere with study drug (consult sponsor for review of medication prior to enrollment)
    d. CD4 count <350 at screening
    e. AIDS-defining opportunistic infection within 6 months of start of screening
    11. Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction
    12. History of seizure or any condition that may predispose to seizure (including, but not limited to, prior stroke, transient ischemic attack, or loss of consciousness ≤1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
    13. Treatment with drugs known to lower the seizure threshold within 4 weeks prior to randomization
    14. Gastrointestinal conditions affecting absorption
    15. Known or suspected contraindications or hypersensitivity to apalutamide, abiraterone acetate, GnRH agonists or any of the components of the formulations
    16. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject
    1. Presencia de metástasis a distancia (Estadío clínico M1) La presencia de nódulos antes de la bifurcación iliaca (estadío clínico N1) no es criterio de exclusión. El diagnóstico de metástasis a distancia (estadío clínico M; MO versus M1a, M1b, M1c) y la enfermedad nodal pélvica (estadío clínico N; N1 versus NO) serán evaluados por un revisor central radiológico. Los pacientes sólo serán elegibles si se confirma un estadío clínico MO)

    2. Tratamiento previo con antiandrógenos

    3. Cualquier tratamiento previo para el cáncer de próstata

    4. Diagnóstico anatomo patológico de cáncer de células pequeñas, ductal o carcinoma neuroendrocrino de la próstata

    5. Orquiectomía bilateral

    6. Historia previa de cualquier radioterapia pélvica

    7. Tratamiento previo con cualquier fármaco en investigación en las 4 semanas previas a la aleatorización

    8. Cualquier cirugía mayor en las 4 semanas previas a la aleatorización

    9. Presencia de cualquiera de los siguientes diagnósticos en los 6 meses previos a la primera dosis de fármaco de estudio: Angina inestable o severa, infarto de miocardio, fallo cardiaco congestivo sintomático, cualquier evento tromboembólico a nivel venoso o arterial (ejemplo embolia pulmonar, accidente cerebrovascular incluyendo isquemias transitorias), o arritmias ventriculares clínicamente significativas o enfermedad cardiaca de clase II a IV según la asociación cardiaca de Nueva York

    10. Pacientes con diagnóstico positivo al virus de la inmunodeficiencia humana adquirida con al menos uno de los siguientes:

    a. No estén recibiendo tratamiento con anti retrovirales de forma activa

    b. Han tenido un cambio en su tratamiento con anti retrovirales en los 6 meses previos a comenzar la fase de selección

    c. Estar recibiendo terapia anti retroviral que pudiese interferir con los fármacos de estudio (consultar con el promotor del estudio la medicación antes de la aleatorización)

    d. Recuento celular de linfocitos CD4 menor a 350 en la fase de selección

    e. Infección oportunista asociada a síndrome de la inmunodeficiencia adquirida en los 6 meses previos al inicio de la fase de selección

    11. Enfermedad crónica hepática o infección active o sintomática de hepatitis vírica; desordenes relacionados con ascitis o sangrado secundarios a disfunción hepática

    12. Historia de convulsiones o cualquier otra condición que pudiese predisponer a las convulsiones (incluyendo, pero no limitado a, infartos cerebrales previos, ataques isquémicos, o pérdida de conciencia en al menos un año antes de la aleatorización, malformación arteriovenosa cerebral, o masas cerebrales como los menangiomas o tumores de células de Schwann que pudiesen causar edemas o efectos masa)

    13. Tratamiento con cualquier fármaco que tenga potencial de poder provocar convulsiones en las 4 semanas previas a la randomización

    14. Cualquier condición que afecte a la absorción gastrointestinal

    15. Cualquier contraindicación conocida o sospecha de contraindicación o hipersensibilidad a apalutamida, acetato de abiraterona, agonistas de GnRH o cualquier otro de los excipientes

    16. Cualquier otra condición que a criterio del investigador contraindicase la participación del paciente en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    1. pCR rate (assessed by blinded independent pathological review)
    2. MFS (evaluated by blinded independent central review [BICR])
    1. Índice de RpC (evaluado mediante una revisión patológica ciega independiente)
    2. SLM (evaluada mediante una revisión central ciega independiente (RCCI))
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. at radical prostatectomy
    2. until documented distant metastasis, death, lost to follow-up, withdrawal of consent, or termination of the study by the sponsor, whichever occurs first
    1. En el momento de la prostatectomía radical
    2. Hasta presencia documentada de metástasis a distancia, muerte, pérdida de seguimiento, retirada del consentimiento o terminación del estudio por el promotor, lo que ocurra primero
    E.5.2Secondary end point(s)
    1. PSA-free survival
    2. Progression-free survival (PFS)
    3. Adverse events (AEs), clinical laboratory tests, and treatment compliance
    1. Supervivencia sin progresión bioquímica (en función del antígeno específico prostático (PSA)
    2. Supervivencia libre de progresión (SLP)
    3. Acontecimientos adversos (AEs), resultados de análisis clínicos y adherencia al tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. the time from randomization to the first detectable serum PSA level with recovered testosterone levels after undetectable PSA post-radical prostatectomy with lymph node dissection (RPLND) or death, whichever occurs first
    2. time from randomization to first documentation of BICR-confirmed radiographic progressive disease or death due to any cause (whichever occurs first) + 1 day
    3. from signing of consent until 30 days after last dose of study drug. Clinical Labs & compliance per T&E on treatment
    1. Tiempo desde la aleatorización hasta el primer nivel detectable de PSA sérico acompañado de recuperación de niveles de testosterona tras unos niveles de PSA indetectables después de la prostatectomía radical con linfadenectomía o la muerte, lo que ocurra primero

    2. Tiempo desde la aleatorización hasta la primera evidencia documentada de progresión radiográfica o muerte independientemente de la causa (lo que ocurra primero) más 1 día

    3. Desde la firma del consentimiento informado hasta 30 días después de la toma de la última dosis del fármaco de estudio. Análisis de laboratorio y cumplimiento del tratamiento en función del calendario del estudio durante el tratamiento
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers and tolerability
    Biomarcadores y tolerabilidad
    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 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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA73
    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
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    China
    Czech Republic
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Russian Federation
    Spain
    Taiwan
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days9
    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: 1200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state78
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 590
    F.4.2.2In the whole clinical trial 1500
    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)
    subsequent treatment is at investigator discretion
    Tratamiento posterior a criterio del investigador
    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 Decision2019-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-30
    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA