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    Summary
    EudraCT Number:2015-004617-25
    Sponsor's Protocol Code Number:ENZART
    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:2017-02-28
    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 number2015-004617-25
    A.3Full title of the trial
    Enzalutamide and hypofractionated radiation therapy in intermediate-risk localized prostate cancer
    Enzalutamida y radioterapia hipofraccionada en cáncer de próstata localizado de riesgo intermedio.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Enzalutamide and hypofractionated radiation therapy in intermediate-risk localized prostate cancer
    Enzalutamida y radioterapia hipofraccionada en cáncer de próstata localizado de riesgo intermedio.
    A.4.1Sponsor's protocol code numberENZART
    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 SponsorFundación Canaria de Investigación Sanitarias
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 organisationHospital Universitario Gran Canaria Dr Negrín
    B.5.2Functional name of contact pointServicio de Oncología radioterápica
    B.5.3 Address:
    B.5.3.1Street AddressBarranco de La Ballena s/n
    B.5.3.2Town/ cityLas Palmas de Gran Canaria
    B.5.3.3Post code35019
    B.5.3.4CountrySpain
    B.5.4Telephone number+34928450284
    B.5.5Fax number+34928449127
    B.5.6E-mailcrolp@hotmail.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 holderEU/1/13/846/001
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cáncer de próstata localizado de riesgo intermedio
    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 19.1
    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
    Evaluate the efficacy of the enzatulamide with hipofractioned radiotherapy in intermediate-risk localized prostet cáncer in relation with the reduction of the PSA levels.
    Evaluar la eficacia de enzalutamida administrada concomitantemente con radioterapia hipofraccionada en cáncer de próstata localizado de riesgo intermedio, en la reducción de los niveles de PSA.
    E.2.2Secondary objectives of the trial
    Evaluate the induced modification by the enzatulamida in relation with:
    hormonal levels
    bone mineral density
    changes in the metabolic markers
    life quality
    safety and tolerability
    Evaluar la modificación inducida por enzalutamida en relación con:
    Niveles hormonales (andrógenos y estrógenos)
    Densidad mineral ósea (medida por densitometría)
    Cambios en marcadores metabólicos
    Calidad de vida
    Seguridad y tolerabilidad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. More than 18 years
    2. Life expectancy> 10 years.
    3. Diagnosis of prostate carcinoma, histologically confirmed
    4. ECOG Score ≤ 1.
    5. Participants with an adequate organic function, defined as:
    A. Leukocytes ≥3,000 / mcL
    B. Platelets ≥80,000 / mcL
    C. Bilirubin Total <2X upper limit of normality (ULN)
    D. SGOT (AST) / SGPT (ALT) ≤ 2.5 X LSN
    and. Creatinine clearance ≥ 60 ml / min or creatinine ≥2 x ULN
    6. Potentially fertile patients should use effective contraceptive methods (barrier methods plus other contraceptive methods) before entering the study and during their participation in the study.
    7. Patients must sign an informed consent document prior to enrollment in the study.
    8. Patients should be available for clinical follow-up.
    1. Mayores de 18 años.
    2. Esperanza de vida > 10 años.
    3. Diagnóstico de carcinoma de próstata confirmado por histología.
    4. Puntuación ECOG ≤ 1.
    5. Los participantes deben tener una adecuada función orgánica, definida como:
    a. Leucocitos ≥3,000/mcL
    b. Plaquetas ≥80,000/mcL
    c. Bilirrubina Total < 2X límite superior de la normalidad (LSN)
    d. SGOT (AST)/SGPT (ALT) ≤ 2.5 X LSN
    e. Aclaramiento de creatinina ≥ 60 ml/min o creatinina ≥2 x LSN
    6. Los pacientes potencialmente fértiles deberán utilizar métodos anticonceptivos eficaces (métodos de barrera más otros métodos anticonceptivos) antes de entrar en el estudio y durante su participación en el estudio.
    7. Los pacientes deberán firmar un documento de consentimiento informado antes de su inclusión en el estudio.
    8. Los pacientes deberán estar disponibles para el seguimiento clínico.
    E.4Principal exclusion criteria
    1. Have received any investigational drug within 4 weeks prior to the start of the study treatment.
    2. Prostate Cancer Stage T4 by clinical examination or radiologic evaluation.
    Hypogonadism or severe adrenal deficiency defined by testosterone screening <50ng / dL (ULN)
    4. Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer.
    5. Concomitant use of androgens, anti-androgens, estrogens or progestogens within 6 months prior the enrollment or prior the use of finasteride or dutasteride within 30 days of screening.
    6. Presence of any other malignant neoplasia, different from the current tumor, in the previous 5 years. Patients with skin cancer another than melanoma or superficial bladder cancer (Ta and TIS properly treated) will be accepted. Patients treated for any type of malignancy without relapse in a period of not less than 2 years are eligible for the study.
    7. Uncontrolled intercurrent diseases, or co-morbidities including but not limited to active infectious processes, which the investigator deems inappropriate for enrollment in the study.
    8. Previous history of convulsive episodes or medications that predispose to seizures.
    9. History of syncope or transient ischemic attack within 12 months prior to enrollment.
    10. Clinically significant cardiovascular disease including:
    A. Acute myocardial infarction within 6 months prior to enrollment;
    B. Unstable angina within 3 months prior to enrollment;
    C. NYHA class 3 or 4 congestive heart failure (CHF), or history of NYHA 3 or 4 CHF in the past, unless an echocardiogram was performed within the previous 3 months with a ventricular injection fraction ≥ 45%;
    D. Previous history of clinically significant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, torsades de pointes);
    E. Previous history of second-degree atrioventricular block type Mobitz II or third degree without permanent pacemaker;
    F. Systolic hypotension defined as systolic BP <86 mmHg in 2 consecutive measurements in the screening view;
    G. Bradycardia defined as heart rate <50 bpm in the screening view;
    H. Uncontrolled hypertension defined as systolic BP> 170 mmHg or diastolic BP> 105 mmHg in 2 consecutive measurements in the screening view;
    I. Electrocardiogram abnormalities that demonstrate toxicity equal to or greater than degree III toxicity according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
    11. Previous history of gastrointestinal disorders (medical conditions or extensive surgeries) that may interfere with adequate absorption of the drug within 3 months prior to enrollment.
    12. Major surgery within 4 weeks prior to screening.
    13. Prior use or participation in a clinical trial of an androgen-blocking investigational drug (eg, abiraterone acetate, TAK-700, TAK-683, TAK-448) or using as therapeutic targets androgen receptors . (E.j., enzyalutamide, BMS 641988), or prior use of ketoconazole.
    14. Any condition that in the opinion of the investigator interferes with the patient's ability to participate in the trial, placing the patient at undue risk, or complicating the interpretation of the safety data.
    15. The use of herbalist or alternative medicine that may affect the hormonal profile such as Prostasol or PC-SPES.
    1. Haber recibido cualquier droga investigacional dentro de las 4 semanas previas al inicio del tratamiento de estudio.
    2. Cáncer de Próstata Estadio T4 por examen clínico o evaluación radiológica.
    3. Hipogonadismo o deficiencia adrenal severa definida por el cribado de testosterona < 50ng/dL (LSN)
    4. Deprivación androgénica previa, quimioterapia, cirugía o radiación para el cáncer de próstata.
    5. Uso concomitante de andrógenos, anti-andrógenos, estrógenos o progestágenos, dentro de los 6 meses previos al enrolamiento o el uso de finasteride o dutasteride dentro de los 30 primeros días del screening.
    6. Presencia de cualquier otra neoplasia maligna, distinta del tumor actual, en los 5 años anteriores. Se aceptarán pacientes con cáncer cutáneo distinto de melanoma o con cáncer superficial de vejiga (Ta y TIS adecuadamente tratados). Pacientes tratados para cualquier tipo de malignidad sin recaídas en un periodo no menor de 2 años son elegibles para el estudio.
    7. Enfermedades intercurrentes no controladas, o co-morbilidades incluyendo pero no limitando a procesos activos infecciosos, que el investigador considere inapropiadas para el enrolamiento en el estudio.
    8. Historia previa de episodios convulsivos o medicamentos que predispongan a convulsiones.
    9. Historia de síncope o accidente isquémico transitorio dentro de los 12 meses previos al enrolamiento.
    10. Enfermedad cardiovascular clínicamente significativa que incluye:
    a. Infarto agudo de miocardio dentro de los 6 meses previos al enrolamiento;
    b. Angina inestable dentro de los 3 meses previos al enrolamiento;
    c. Insuficiencia cardiaca congestiva (ICC) clasificación NYHA 3 o 4, o historia de ICC NYHA 3 o 4 en el pasado, a menos que un ecocardiograma se realice dentro de los 3 meses previos con una fracción de inyección ventricular ≥ 45%;
    d. Historia previa de arritmias ventriculares clínicamente significativas (ej., taquicardia ventricular, fibrilación ventricular, torsades de pointes);
    e. Historia previa de bloqueo aurículo-ventricular de segundo grado tipo Mobitz II o tercer grado sin marcapasos permanente;
    f. f. Hipotensión sistólica definida como TA sistólica < 86 mmHg en 2 mediciones consecutivas en la vista de screening;
    g. Bradicardia definida como frecuencia cardiaca <50 lpm en la vista de screening;
    h. Hipertensión no controlada definida como TA sistólica > 170 mmHg o TA diastólica > 105 mmHg en 2 mediciones consecutivas en la vista de screening;
    i. Alteraciones en el electrocardiograma que demuestren una toxicidad igual o mayor a grado de toxicidad III de acuerdo a NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
    11. Historia previa de trastornos gastrointestinales (condiciones médicas o cirugías extensas) que puedan interferir con la absorción adecuada del fármaco dentro de los 3 meses previos al enrolamiento.
    12. Cirugía mayor dentro de las 4 semanas previas al screening.
    13. Uso previo, o participación en un ensayo clínico de una droga investigacional bloqueante de la síntesis de andrógenos (ej., acetato de abiraterone, TAK-700, TAK-683, TAK-448) o que utilicen como dianas terapéuticas los receptores androgénicos. (e.j., enzalutamida, BMS 641988), o uso previo de ketoconazol.
    14. Cualquier condición, que en opinión del investigador interfiera con la capacidad del paciente para participar en el ensayo, colocar al paciente en riesgo indebido, o que complique la interpretación de los datos de seguridad.
    15. El uso de herbolario o medicina alternativa que pueda afectar el perfil hormonal como Prostasol o PC-SPES.
    E.5 End points
    E.5.1Primary end point(s)
    PSA levels at the end of the treatment with enzalutamide and radiotherapy
    Niveles de PSA tras finalizar el tratamiento con enzatulamida y radioterapia
    E.5.1.1Timepoint(s) of evaluation of this end point
    at first month, week 25, third month and sixth month
    al mes, semana 25, 3 meses y a los 6 meses
    E.5.2Secondary end point(s)
    hormonal levels
    bone mineral density
    life quality
    safety and tolerability
    densidad mineral ósea, calidad de vida
    Niveles hormonales (andrógenos y estrógenos)
    seguridad y tolerabilidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    hormonal levels : month 1, week 25, month3 and month 6.
    bone mineral density: week 25
    safety and tolerability: first month later tan the last dose of enzalutamide and for the follow-up visits.
    densidad mineral ósea, calidad de vida: semana 25
    niveles hormonales: al mes, semana 25, 3 meses y a los 6 meses
    seguridad y tolerabilidad: al mes última dosis enlazutamida y visitas de seguimiento.
    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 No
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end of the trials is the last visit of the last subject undergoing in the trail
    Fin de estudio se define como la última visita realizada al último paciente reclutado.
    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 months
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 50
    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 state70
    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)
    none
    ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
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