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    The EU Clinical Trials Register currently displays   43931   clinical trials with a EudraCT protocol, of which   7307   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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    EudraCT Number:2015-000735-32
    Sponsor's Protocol Code Number:56021927PCR3002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-17
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-000735-32
    A.3Full title of the trial
    A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in
    Subjects with Metastatic Hormone-sensitive Prostate Cancer
    Studio di fase III, randomizzato, in doppio cieco, controllato con placebo su Apalutamide in combinazione con la terapia di deprivazione androgenica (ADT) verso la sola ADT in soggetti con carcinoma della prostata metastatico ormono-sensibile (mHSPC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study of Apalutamide Plus Androgen Deprivation Therapy
    (ADT) Versus ADT in Participants with mHSPC
    Uno studio di fase 3 su Apalutamide in combinazione con la terapia di deprivazione androgenica (ADT) verso la sola ADT in soggetti con mHSPC
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number56021927PCR3002
    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.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 CILAG INTERNATIONAL NV
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJANSSEN CILAG INTERNATIONAL NV
    B.5.2Functional name of contact pointCLINICAL REGISTRY GROUP
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.4Telephone number0031715242166
    B.5.5Fax number0031715242110
    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 nameJNJ-56021927
    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 INNJNJ-56021927
    D.3.9.1CAS number 956104-40-8
    D.3.9.2Current sponsor codeJNJ-56021927
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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)
    Carcinoma della prostata metastatico ormono-sensibile (mHSPC).
    E.1.1.1Medical condition in easily understood language
    Prostate Cancer
    Tumore della prostata
    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
    The primary objective is to determine if the addition of Apalutamide to
    ADT provides superior efficacy in improving radiographic progression-free
    survival (rPFS) or overall survival (OS) for subjects with mHSPC.
    L'obiettivo primario consiste nel determinare se associando Apalutamide con la ADT la sopravvivenza senza progressione radiografica (rPFS) o la sopravvivenza generale (OS) in soggetti affetti da carcinoma della prostata metastatico ormono-sensibile (mHSPC) migliora significativamente
    E.2.2Secondary objectives of the trial
    To evaluate clinically relevant improvements with addition of Apalutamide to ADT including delays in pain progression and opioid use for
    prostate cancer, skeletal-related events, and the need for cytotoxic
    To characterize the safety of adding Apalutamide to ADT in subjects
    with mHSPC
    To characterize the population pharmacokinetics (PK) and pharmacodynamics (PD) of Apalutamide
    To evaluate the concentration of leuprolide and assess the PD effect of leuprolide on testosterone concentrations when used alone or in
    combination with Apalutamide
    * To evaluate the treatment effectiveness with the addition of
    Apalutamide to ADT for the subpopulations of subjects with mHSPC
    -Valutazione dei principali miglioramenti clinici legati all'associazione di Apalutamide alla terapia ADT, inclusi eventuali ritardi nella progressione del dolore e nell¿utilizzo di oppiacei per il cancro alla prostata, eventi legati allo scheletro e la necessit¿ di effettuare chemioterapia citotossica.
    ¿ Valutazione della sicurezza legata all'aggiunta di Apalutamide alla terapia ADT in pazienti con mHSPC.
    ¿ Valutazione della farmacocinetica (PK) e farmacodinamica (PD) di Apalutamide.
    ¿ Valutazione della concentrazione di leuprolide nonch¿ l'effetto farmacodinamico (PD) del leuprolide sulle concentrazioni di testosterone utilizzato da solo o in combinazione con Apalutamide.
    - Valutare l'efficacia del trattamento con l'aggiunta dell'Apalutamide all'ADT nelle sottopopolazioni di soggetti con mHSPC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of prostate adenocarcinoma as confirmed by the investigator
    - Metastatic disease documented by greater than or equal to (>=) 1
    bone lesions on 99mTc bone scan. Participants with a single bone lesion
    must have confirmation of bone metastasis by computed tomography
    (CT) or magnetic resonance imaging (MRI)
    - Eastern Cooperative Oncology Group Performance Status (ECOG PS)
    grade of 0 or 1
    - Participants who received docetaxel treatment must meet the following criteria:
    a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC;
    b) Received the last dose of docetaxel <=2 months prior to
    c) Maintained a response to docetaxel of stable disease or better, by
    investigator assessment of imaging and PSA, prior to randomization
    - Other allowed prior treatment for mHSPC:
    a) Maximum of 1 course of radiation or surgical intervention; radiation
    therapy for metastatic lesions must be completed prior to
    b) Less than or equal to (<=) 6 months of ADT prior to randomization
    - Allowed prior treatments for localized prostate cancer (all treatments
    must have been completed >= 1 year prior to randomization)
    a) <= 3 years total of ADT;
    b) All other forms of prior therapies including radiation therapy,
    prostatectomy, lymph node dissection and systemic therapies
    - La diagnosi di adenocarcinoma alla prostata deve essere confermata dallo sperimentatore.
    - Malattia metastatica documentata da =1 lesione ossea con scintigrafia ossea al Tecnezio 99m (99mTc). I soggetti con una lesione ossea devono avere la conferma di tale lesione alla TAC oppure RMN.
    - Grado di PS ECOG di 0 e 1.
    - I soggetti trattati in precedenza con docetaxel devono rispettare i seguenti criteri:
    a) Aver assunto al massimo 6 cicli di docetaxel per l’mHSPC;
    b) Aver assunto l’ultima dose di docetaxel 2 mesi prima della randomizzazione;
    c) Avere una risposta almeno stabile al docetaxel, sulla base delle immagini valutate dallo sperimentatore e ai livelli di PSA, prima della randomizzazione.
    - Terapie pregresse per l’mHSPC:
    a) Massimo un ciclo di radioterapia oppure intervento chirurgico; la radioterapia palliativa per le metastasi deve essere completata prima della randomizzazione;
    b) < 6 mesi di ADT prima della randomizzazione.
    - Trattamenti permessi per il cancro alla prostata localizzato, completati un anno prima dalla randomizzazione:
    a) < 3 mesi di ADT;
    b) Tutte le tipologie di terapie comprese la radioterapia, la prostatectomia, la dissezione dei linfonodi e le terapie sistemiche.
    E.4Principal exclusion criteria
    - Pathological finding consistent with small cell, ductal or
    neuroendocrine carcinoma of the prostate
    - Known brain metastases
    - Lymph nodes as only sites of metastases
    - Visceral (ie, liver or lung) metastases as only sites of metastases
    - Other prior malignancy within 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer
    - Prior treatment with other next generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for
    prostate cancer
    - History of seizures or medications known to lower seizure threshold
    - Referti patologici coerenti con il carcinoma della prostata a piccole cellule, duttali o neuroendocrine
    - Metastasi cerebrali note
    - Metastasi solo ai linfonodi.
    -Metastasi viscerali (es. polmone e fegato) come unico sito di metastasi
    -Altre neoplasie maligne precedenti entro 5 anni dalla randomizzazione ad eccezione di carcinoma della pelle a cellule squamose o carcinoma superficiale alla vescica non invasivo.
    -Precedente trattamento con altri anti-androgeni di successive generazioni. o altri inibitori CYP17, immunoterapia o agenti radiofarmaceutici per la cura del cancro alla prostata.
    -Anamnesi di crisi epilettiche o farmaci conosciuti per abbassare la soglia di attacco.
    E.5 End points
    E.5.1Primary end point(s)
    - Radiographic Progression-Free Survival (rPFS)
    - Overall Survival (OS)
    - Sopravvivenza senza progressione radiografica
    - Sopravvivenza generale
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Up to 54 Months
    - Up to 54 Months
    - Fino a 54 mesi
    - Fino a 54 mesi
    E.5.2Secondary end point(s)
    - Time to Pain Progression
    - Time to Skeletal-Related Event (SRE)
    - Time to Chronic Opioid Use
    - Time to Initiation of Cytotoxic Chemotherapy
    - Tempo alla progressione del dolore
    - Tempo prima dell'evento legato allo scheletro (SRE)
    - Tempo all'utilizzo cronico di oppiodi
    - Tempo di inizio della chemioterapia con citotossico
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Up to 54 Months
    - Up to 54 Months
    - Up to 54 Months
    - Up to 54 Months
    - Fino a 54 mesi
    - Fino a 54 mesi
    - Fino a 54 mesi
    - Fino a 54 mesi
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers and tumour response assessments
    Biomarker e valutazioni di risposta del tumore
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Korea, Republic of
    Russian Federation
    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
    EoT Visit is within 30 days after the last dose of study drug for all
    Visita di fine trattamento: entro 30 giorni dopo l'ultima somministrazione del farmaco in studio per tutti i soggetti
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months4
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 1000
    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)
    In the event of a positive study result at either of the interim analyses
    or at the final analysis, all subjects in the treatment Phase will have
    the opportunity to enroll in an Open-label Extension Phase, which will
    allow subjects to receive active drug (Apalutamide) for up to 3 years.
    In caso di risultato positivo dello studio ad una delle analisi ad interim o all'analisi finale, tutti i soggetti in trattamento avranno l'opportunit¿ di essere arruolati in un fase di estensione in aperto che consentir¿ ai pazienti di ricevere il farmaco attivo (Apalutamide) fino a ulteriori 3 anni
    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 Decision2015-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-04
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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