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    Summary
    EudraCT Number:2007-001703-38
    Sponsor's Protocol Code Number:ARI109924
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-07
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2007-001703-38
    A.3Full title of the trial
    Estudio aleatorizado, doble ciego, controlado con placebo, para evaluar la eficacia y seguridad de 0,5 mg de dutasterida (AVIDART®) en prolongar el tiempo hasta la duplicación de los niveles de PSA en hombres con cáncer de próstata y fracaso bioquímico (aumento del PSA) después del tratamiento con terapia radical con intención curativa (ARTS – AVIDART® after Radical Therapy for prostate cancer Study)

    A Randomised, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride (AVODART™) 0.5 mg in Extending the Time to PSA Doubling in Men with Prostate Cancer and Biochemical Failure (PSA increase) after Radical Therapy with Curative Intent (ARTS – AVODART after Radical Therapy for prostate cancer Study)
    A.3.2Name or abbreviated title of the trial where available
    ARTS
    A.4.1Sponsor's protocol code numberARI109924
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithkline S.A.
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 AVODART
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline, SA PTM- C/Severo Ochoa, 2 28760 Tres Cantos Madrid
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameAVODART
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDutasterida
    D.3.9.1CAS number 164656-23-9
    D.3.9.2Current sponsor codeGI198745
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Cáncer de próstata clínicamente localizado
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar el efecto de dutasterida 0,5 mg al día frente a placebo en el tiempo hasta la duplicación de los niveles de PSA.
    E.2.2Secondary objectives of the trial
    •Evaluar el efecto de dutasterida frente a placebo en:
    la progresión de la enfermedad
    la respuesta al tratamiento
    los cambios en el PSA y el PSADT
    •Evaluar los cambios en la ansiedad del paciente, determinados mediante la escala de ansiedad para el cáncer de próstata (MAX-PC, del inglés Memorial Anxiety Scale for Prostate Cancer), de dutasterida frente a placebo
    •Evaluar la seguridad de dutasterida frente a placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Características demográficas y basales:
    1.Varones con edad <85 años.
    2.Sin anomalías clínicamente relevantes en el ECG de selección.
    Características de la enfermedad:
    3.Pacientes con fracaso de PSA asintomático después de una terapia radical con intención curativa para el cáncer de próstata clínicamente localizado. El fracaso de PSA viene definido por lo siguiente:
    a.Después de la radioterapia primaria:
    i.observar 3 elevaciones en el nivel de PSA respecto al nadir de PSA, mediando al menos 4 semanas entre cada determinación, y un nivel de PSA final ≥2 ng/mL por encima del nadir de PSA.
    ii.El tiempo transcurrido desde la radioterapia deberá ser de al menos 1 año desde la finalización de la misma.
    b.Después de la prostatectomía radical y la radioterapia de rescate:
    i.observar 3 elevaciones en el nivel de PSA respecto al nadir de PSA, mediando al menos 4 semanas entre cada determinación, y siendo cada elevación del nivel de PSA ≥0,2 ng/mL y el nivel de PSA final ≥0,4 ng/mL (el nadir de PSA se define como el menor valor de PSA alcanzado tras la terapia).
    4.Niveles séricos de PSA:
    a.≥2 ng/mL y ≤20ng/mL para los pacientes con radioterapia primaria,
    b.≥0.4 ng/ml y ≤10 ng/ml para los pacientes con prostatectomía radical y radioterapia de rescate.
    5.PSADT >3 meses y ≤24 meses.
    6.Estadio clínico T1-T3a N0 M0.
    7.Cáncer de próstata no metastásico, confirmado con un resultado negativo en la gammagrafía ósea realizada en un plazo de 6 meses antes de la visita de selección (visita 1).
    8.Sin pruebas de recurrencia local en pacientes con prostatectomía radical o radioterapia de rescate.
    9.Con supervivencia previsible ≥2 años.
    10.Estado de funcionalidad del Eastern Cooperative Oncology Group (ECOG) de 0, 1 o 2 (véase apéndice 1).

    Miscelánea:
    11.Capaz de tragar y retener medicación oral.
    12.Capaz y dispuesto a participar durante todo el periodo de estudio de 2 años.
    13.Capaz de leer y escribir (el cuestionario MAX-PC ha de ser cumplimentado por el paciente), de entender las instrucciones relacionadas con los procedimientos del estudio y de otorgar el consentimiento informado por escrito.
    14.En Francia, se considerará que un paciente es elegible para su inclusión en este estudio únicamente si está afiliado o es beneficiario de una de las categorías de la seguridad social.
    E.4Principal exclusion criteria
    Características demográficas y basales:
    1.Cualquier trastorno médico grave inestable, como, entre otros, infarto agudo de miocardio, cirugía de bypass aorto-coronario, angina inestable, arritmias cardiacas, signos evidentes de insuficiencia cardiaca congestiva, o accidente cerebrovascular en los 6 meses previos a la visita 1, o diabetes no controlada o úlcera péptica no controlada médicamente.
    2.Anomalías en las pruebas de función hepática (mayor de 2 veces el límite superior normal [LSN] para la alanino aminotransferasa [ALT], aspartato aminotransferasa [AST] o fosfatasa alcalina [ALP]); o bilirrubina >1,5 veces el LSN).
    3.Creatinina sérica >1,5 veces el LSN.
    4.Antecedentes de otras neoplasias en los 5 años anteriores que pudieran afectar al diagnóstico del cáncer de próstata.
    5.Antecedentes previos o evidencia actual de abuso de fármacos o alcohol en los 12 meses anteriores a la visita 1.
    6.Antecedentes de cualquier patología (incluyendo las psiquiátricas) que, en opinión del investigador, pudiera ser causa de confusión en los resultados del estudio o que constituya un riesgo adicional para el paciente.
    7.Hipersensibilidad conocida a cualquier inhibidor 5-AR o fármaco relacionado químicamente con dutasterida.
    Características de la enfermedad:
    8.Niveles séricos de PSA
    a.>20 ng/mL en pacientes con radioterapia primaria.
    b.>10 ng/mL en pacientes con prostatectomía radical y radioterapia de rescate.
    9.PSADT ≤3 meses o >24 meses.
    10.Fracasos bioquímicos en pacientes que han recibido braquiterapia.
    11.Estadio clínico N+ o M+
    12.Paciente que ha sido tratado previamente para el cáncer de próstata con cualquiera de lo siguiente:
    a.Quimioterapia.
    b.Estrógenos (e.g. megestrol, medroxiprogesterona, ciproterona, Dietilestilbestrol [DES]).
    c.Fármacos con propiedades antiandrogénicas (como espironolactona si es en dosis >50mg/día, flutamida, bicalutamida, ketoconazol, progestágenos) [Nota: está permitido el uso de ketoconazol tópico antes de y durante el estudio, y el uso de cimetidina antes de la inclusión en el estudio].
    d.Análogos de GnRH (como leuprolida, goserelina) excepto cuando se emplean para la radioterapia adyuvante o neoadyuvante (en este caso la utilización no debe haber sido superior a 6 meses y debe haber finalizado al menos 1 año antes de la visita 1).
    e.Orquiectomía.
    Medicaciones concomitantes:
    13.No está permitido el uso de Glucocorticoides, excepto los inhalados o los tópicos, durante los 3 meses anteriores a la visita 1 o durante el estudio.
    14.La utilización actual y/o previa de finasterida (Proscar, Propecia) o la exposición a dutasterida (GI198745, AVODART) durante los 6 meses anteriores a la visita 1.
    15.Los esteroides anabólicos durante los 6 meses anteriores a la visita 1
    16.La participación en cualquier otro estudio con un fármaco en investigación o comercializado durante los 30 días anteriores a la visita 1 o en cualquier momento durante el periodo de estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Tiempo desde el momento basal hasta la duplicación de los niveles de PSA en el grupo de dutasterida en comparación con el grupo placebo.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 EEA81
    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
    E.8.7Trial has a data monitoring committee No
    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
    Final del ensayo es la última visita del último sujeto reclutado
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days21
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 255
    F.4.2.2In the whole clinical trial 276
    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)
    Post-study treatment will not be provided
    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 Decision2007-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-03-15
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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