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    Summary
    EudraCT Number:2021-000943-30
    Sponsor's Protocol Code Number:SOGUG-2019-IEC(PRO)-4
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-07-27
    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 number2021-000943-30
    A.3Full title of the trial
    Randomized phase II study evaluating the clinical utility of switching from prednisone to dexamethasone after initial biochemical progression in patients with hormone-sensitive metastatic prostate cancer treated with abiraterone
    Estudio de fase II aleatorizado de la evaluación de la utilidad clínica del “switch” (o cambio) de prednisona por dexametasona tras progresión bioquímica inicial en pacientes con cáncer de próstata metastásico hormonosensible tratados con abiraterona.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the switch from prednisone to dexamethasone in prostate cancer patients being treated with abiraterone
    Un estudio para evaluar el cambio de prednisona a dexametasona en pacientes con cáncer de próstata que están siendo tratados con abiraterona
    A.4.1Sponsor's protocol code numberSOGUG-2019-IEC(PRO)-4
    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 SponsorSOGUG (Spanish Genitourinary Oncologic Group)
    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 supportSOGUG (Spanish Genitourinary Oncologic Group)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSOGUG (Spanish Genitourinary Oncologic Group)
    B.5.2Functional name of contact pointSecretaría SOGUG
    B.5.3 Address:
    B.5.3.1Street AddressC/ Velázquez 7, piso 3
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28001
    B.5.3.4CountrySpain
    B.5.4Telephone number34610287201
    B.5.6E-mailsecretaria@sogug.es
    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 Dexamethasone
    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 nameDexamethasone
    D.3.4Pharmaceutical form 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 INNDexamethasone
    D.3.9.1CAS number 50-02-2
    D.3.9.3Other descriptive nameDexamethasone
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    metastatic prostate cancer hormone sensitive
    cáncer de próstata metastásico hormonosensible
    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 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.1.2 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 evaluate the rate of PSA progression at 12 weeks in patients with metastatic HSCC who continue treatment with AA after biochemical progression in routine clinical practice and in whom the adjuvant prednisone is replaced by dexamethasone.
    Evaluar la tasa de progresión por PSA a las 12 semanas en pacientes con CPHS metastásico que continúan tratamiento con AA tras la progresión bioquímica dentro de práctica clínica habitual y en los que se realiza el cambio del coadyuvante prednisona por dexametasona
    E.2.2Secondary objectives of the trial
    To compare, in patients with mCPHS who continue treatment with AA after biochemical progression within standard clinical practice and in whom the adjuvant prednisone is replaced by dexamethasone:
    a) The response rate by PSA
    b) Progression-free survival
    c) Overall survival
    d) Toxicity profile
    Comparar, en pacientes con mCPHS que continúan tratamiento con AA tras la progresión bioquímica dentro de práctica clínica habitual y en los que se realiza el cambio del coadyuvante prednisona por dexametasona:
    a) La tasa de respuesta por PSA
    b) La supervivencia libre de progresión
    c) La supervivencia global
    d) El perfil de toxicidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent.
    2. Age equal to or older than 18 years.
    3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) < or = 2.
    4. Histological confirmation of the diagnosis of prostate adenocarcinoma, with no predominance of microcytic or neuroendocrine component.
    5. Patients on treatment with abiraterone 1000mg/24h + prednisone 5mg/24h + androgen deprivation (LHRH analogues or surgical castration) with indication in metastatic hormone-sensitive prostate cancer for at least 12 weeks.
    6. Biochemical progression, defined as:
    a. PSA elevation greater than 25% above nadir, confirmed by a second determination at least 2 weeks later. For inclusion it will be necessary to document both the initial progression value and the confirmation value.
    b. PSA value > or = 2 ng/mL.
    c. Documented progression after at least 12 weeks of treatment.
    7. Blood testosterone levels <0.5 ng/mL.
    8. Absence of radiological progression to abiraterone plus prednisone as determined by the investigator, with no new visceral or nodal lesions, or less than 3 new bone lesions.
    9. Adequate hematologic, hepatic, and renal function as defined by the following parameters:
    a. Hematologic:
    i. Hemoglobin > 9 g/dL
    ii. Leukocytes > 2,000/mm 3
    iii. Neutrophils > 1,000/mm 3
    iv. Platelets > 75,000/mm 3
    b. Hepatic:
    i. GOT < 1.5*LSN (in case of hepatic metastases, < 5*LSN).
    ii. GPT < 1.5*LSN (in case of hepatic metastases, < 5*LSN)
    iii. Total bilirubin < 1.5*LSN (in case of hepatic metastases, < 3*LSN)
    c. Renal:
    i. Creatinine < 2*LSN
    ii. Creatinine clearance > 30 mL/min.
    10. Absence of contraindication for administration of abiraterone acetate according to the data sheet.
    1. Consentimiento informado.
    2. Edad igual o mayor de 18 años.
    3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) < o = 2.
    4. Confirmación histológica del diagnóstico de adenocarcinoma de próstata, sin predominancia de componente microcítico o neuroendocrino.
    5. Pacientes en tratamiento con abiraterona 1000mg/24h + prednisona 5mg/24h + deprivación androgénica (análogos LHRH o castración quirúrgica) con indicación en cáncer de próstata hormonosensible metastásico durante al menos 12 semanas.
    6. Progresión bioquímica, definida como:
    a. Elevación del PSA superior al 25% sobre el nadir, confirmado por una segunda determinación al menos 2 semanas después. Para la inclusión será necesario documentar tanto el valor de progresión inicial como el de confirmación.
    b. Valor de PSA > o = 2 ng/mL
    c. Progresión documentada tras al menos 12 semanas de tratamiento.
    7. Niveles de testosterona en sangre <0.5 ng/mL.
    8. Ausencia de progresión radiológica a abiraterona más prednisona determinada por el investigador, sin nuevas lesiones viscerales o ganglionares, o bien con menos de 3 lesiones óseas nuevas.
    9. Función hematológica, hepática y renal adecuada, definida por los siguientes parámetros:
    a. Hematológica:
    i. Hemoglobina > 9 g/dL
    ii. Leucocitos > 2.000/mm 3
    iii. Neutrófilos > 1.000/mm 3
    iv. Plaquetas > 75.000/mm 3
    b. Hepática:
    i. GOT < 1,5*LSN (en caso de metástasis hepáticas, < 5*LSN)
    ii. GPT < 1,5*LSN (en caso de metástasis hepáticas, < 5*LSN)
    iii. Bilirrubina total < 1,5*LSN (en caso de metástasis hepáticas, < 3*LSN)
    c. Renal:
    i. Creatinina < 2*LSN
    ii. Aclaramiento de creatinina > 30 mL/min
    10. Ausencia de contraindicación para la administración de acetato de abiraterona de acuerdo con la ficha técnica.
    E.4Principal exclusion criteria
    1. Radiological progression in the baseline radiological evaluation, according to RECIST and PCWG3 criteria.
    2. Presence of clinically relevant symptomatology related to the disease, defined as:
    a. Significant pain (score > or = 3 on the Brief Pain Inventory - Short Form (BPI-SF), item 3).
    b. Presence of adverse effects > or = grade 2 that, in the judgment of the investigator, related to the baseline disease (adverse effects related to the toxicity of the related treatment will be accepted).
    3. Biochemical, radiological or clinical progression in the 12 weeks since initiation of abiraterone + prednisone for the treatment of CPHSm.
    4. Prior diagnosis of cancer, except:
    a. Patients diagnosed with a localized malignant tumor treated with curative intent, free of disease after curative intent, free of disease after 3 years.
    b. Patients diagnosed with skin tumors (of non-melanoma type) or intervened carcinomas in situ.
    5. Any comorbidity that, in the judgment of the investigator, contraindicates the administration of dexamethasone as an adjuvant corticoid to treatment with abirateracetate with abiraterone acetate.
    6. Medical, psychiatric or any other condition, which, in the investigator's judgment, would interfere with the interferes with the subject's ability to give informed consent, or safely carry out the procedures required in the study.
    1. Progresión radiológica en la evaluación radiológica basal, según criterios RECIST y PCWG3.
    2. Presencia de sintomatología clínicamente relevante relacionada con la enfermedad, definida como:
    a. Dolor significativo (puntuación> o = 3 en la escala Brief Pain Inventory - Short Form (BPI-SF), ítem 3).
    b. Presencia de efectos adversos > o = grado 2 que, a juicio del investigador, estén relacionados con la enfermedad de base (se aceptará efectos adversos relacionados con la toxicidad del tratamiento).
    3. Progresión bioquímica, radiológica o clínica en las 12 semanas desde el inicio de abiraterona + prednisona para el tratamiento del CPHSm.
    4. Diagnóstico previo de cáncer, exceptuando:
    a. Pacientes diagnosticados de un tumor maligno localizado tratado con intención curativa, libres de enfermedad después de 3 años.
    b. Pacientes diagnosticados de tumores de piel (de estirpe no melanoma) o carcinomas in situ intervenidos.
    5. Cualquier comorbilidad que, a juicio del investigador, contraindique la administración de dexametasona como corticoide coadyuvante del tratamiento con acetato de abiraterona.
    6. Antecedentes médicos, psiquiátricos o de cualquier otra condición, que a criterio del investigador interfieran a la hora de que el sujeto otorgue su consentimiento informado, o lleve a cabo con seguridad los procedimientos requeridos en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Rate or proportion of patients with progression by PSA
    Tasa o proporción de pacientes con progresión por PSA
    E.5.1.1Timepoint(s) of evaluation of this end point
    At progression
    En el momento de la progresión
    E.5.2Secondary end point(s)
    - Rate or proportion of patients with PSA response
    - Radiologic progression-free survival
    - Radiological response rate
    - Clinical progression-free survival
    - Overall survival
    - Toxicity
    - Tasa o proporción de pacientes con respuesta por PSA
    - Supervivencia libre de progresión radiológica
    - Tasa de respuesta radiológica
    - Supervivencia libre de progresión clínica
    - Supervivencia global
    - Toxicidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    Toxicity: throughout the trial. The rest, at the time of progression.
    Toxicidad: a lo largo del ensayo. El resto, en el momento de la progresión.
    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 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 Yes
    E.8.1.1Randomised Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned15
    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
    Last Subject Last Visit
    Última visita del último paciente
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 110
    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)
    Standard of care
    Tratamiento estándard
    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 Decision2022-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-06-23
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