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    Summary
    EudraCT Number:2019-002104-40
    Sponsor's Protocol Code Number:CNIO-CP-2019-01
    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:2019-08-09
    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 number2019-002104-40
    A.3Full title of the trial
    A phase II, open-label, biomarker-guided study of Carboplatin efficacy in pretreated metastatic castration-resistant Prostate Cancer (mCRPC)-BioChiP
    Estudio de fase II, abierto, guiado por biomarcadores de la eficacia de carboplatino en pacientes con cáncer de próstata resistente a la castración metastásico previamente tratados (CPRCm)-BioChiP
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Carboplatin in mCRPC
    Carboplatino en CPRCm
    A.3.2Name or abbreviated title of the trial where available
    BioChiP
    BioChiP
    A.4.1Sponsor's protocol code numberCNIO-CP-2019-01
    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 SponsorCentro Nacional de Investigaciones Oncológicas (CNIO)
    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 supportU.S Department of Defense
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentro Nacional de Investigaciones Oncológicas, CNIO
    B.5.2Functional name of contact pointProstate Cancer Unit
    B.5.3 Address:
    B.5.3.1Street AddressMelchor Fernandez Almagro 3
    B.5.3.2Town/ citymadrid
    B.5.3.3Post code28029
    B.5.3.4CountrySpain
    B.5.4Telephone number00349173280002950
    B.5.5Fax number0034912246931
    B.5.6E-mailprostac@cnio.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.2.1.2Country 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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcis-diamina (1,1-ciclobutanodicarboxilato) platino
    D.3.9.1CAS number 41575-94-4
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 castration resistant
    Cáncer de próstata resistente a la castración metastásico
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant 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 estimate the efficacy of single agent carboplatin, as measured by response rate, in three different cohorts of patients with progressive metastatic CRPC
    Estimar la eficacia de carboplatino en monoterapia en base a la tasa de respuesta en las 3 cohortes de pacientes con CPRCm en progresión
    E.2.2Secondary objectives of the trial
    -To evaluate the safety and tolerability of carboplatin in each patient cohort
    -To estimate the efficacy of carboplatin, as measured by time to prostate-specific antigen progression (TTPP) in each patient cohort
    -To estimate the efficacy of carboplatin, as measured by radiographic progression-free survival (rPFS) in each patient cohort
    -To estimate the efficacy of carboplatin, as measured by Clinical progression-free survival (cPFS) in each patient cohort
    -To estimate the efficacy of carboplatin, as measured by composite progression-free survival (compPFS) in each patient cohort
    -To estimate the effect on overall survival (OS) in each patient cohort
    -Evaluar la seguridad y tolerabilidad de carboplatino en cada cohorte de pacientes
    -Estimar la eficacia de carboplatino en base al tiempo a la progresión por PSA (TPP) en cada cohorte
    -Estimar la eficacia de carboplatino en base a la supervivencia libre de progresión radiológica (SLPr) en cada cohorte
    -Estimar la eficacia de carboplatino en base a la supervivencia libre de progresión clínica (SLPc) en cada cohorte
    -Estimar la eficacia de carboplatino en base a la supervivencia libre de progresión compuesta (SLPcomp) en cada cohorte
    -Estimar la eficacia de carboplatino en base a la supervivencia global (SG) en cada cohorte
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pre-screening Inclusion Criteria:
    • Signed prescreening informed consent form
    • Male ≥18 years old
    • Histologically, or cytologically, confirmed adenocarcinoma of the prostate
    • Evidence of metastatic CRPC amenable for tumors biopsies, with distant metastases documented by radionuclide bone scan, CT scan or MRI
    • Ongoing therapy with luteinizing hormone releasing hormone (LH-RH) analogue or bilateral orchiectomy with serum testosterone < 50 ng/dl. If the method of castration is LH-RH analogue, the patient must be willing to continue the use of LH-RH agonists if he starts on study treatment.
    • Patients treated or who are receiving systemic treatment for Prostate Cancer which include at least 1 taxane-based chemotherapy and 1 ARSi (enzalutamide and/or abiraterone acetate/prednisone and/or apalutamide and/or darolutamide). Patients could have had this treatment either as consecutive single agent or in combination, either for mHSPC, mCRPC or nmCRPC but must have received at least 12 weeks of chemotherapy and ARSi or be intolerant to one and/or both
    • Unconfirmed biochemical/radiographic progression or clinical progression
    • According to the treating physician and institutional protocols, the subject is fit and there are no contraindications to undergo a biopsy procedure
    • Adequate coagulation: INR or PT ≤ 1.5 x ULN. Patients ongoing anticoagulant therapy must switch to low molecular weight heparin at least one week before doing biopsy
    • ECOG performance status ≤2
    • Subjects must agree to undergo all the study procedures, including the fresh-tumor biopsy
    Cohort A additional inclusion criteria
    • Patients eligible to Cohort A (with previously known DDR) must have received at least one PARP inhibitor
    Inclusion Criteria (screening):
    • Pre-screening inclusion criteria
    • Patients must have progressive disease defined as at least one of the following:
    - Progressive measurable disease by RECIST 1.1
    - Bone scan progression according to the PCWG3 criteria
    - A ≥25% increase in PSA with an absolute increase of ≥2 ng/mL from the nadir, and which is confirmed by a second value ≥3 weeks later according to the PCWG3
    • Adequate haematological function: platelet count ≥100.000/mm3, absolute neutrophil count (ANC) ≥1.500/mm3, haemoglobin ≥9g/dL without receiving more than 1 transfusion in the last 4 weeks
    • Adequate liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5 x upper limit of normal (ULN), bilirubin (total) ≥2 x ULN, or ≤ 5 times the ULN if liver metastases are present
    • Adequate renal function: for subjects with serum creatinine >1.5 x ULN, calculated creatinine clearance must be >30 ml/min (Gault and Cockroft method)
    • Subjects capable of maintaining sexual intercourse and therefore of fathering children, must agree to use an effective method of contraception for the duration of the trial and 6 months after last dose
    Criterios de inclusión de pre-selección
    • Firma del consentimiento informado de pre-selección
    • Varones ≥18 años de edad
    • Confirmación histológica o citológica de adenocarcinoma de próstata
    • Evidencia de CPRC metastásico biopsiable, con metástasis a distancia evaluables mediante gammagrafía ósea, tomografía computarizada o resonancia magnética
    • Tratamiento continuo con análogos de la hormona liberadora de hormona luteinizante (LH-RH) u orquiectomía bilateral con testosterona sérica <50 ng/dl. Si el método de castración es el análogo de LH-RH, el paciente debe estar dispuesto a continuar con el uso del mismo si comienza el tratamiento del estudio
    • Pacientes tratados previamente o que se encuentren recibiendo tratamiento sistémico para su cáncer de próstata, que incluya al menos 1 quimioterapia basada en taxanos y 1 ARSi (enzalutamida y/o acetato de abiraterona/prednisona y/o apalutamida y/o darolutamida). Los pacientes pueden haber recibido este tratamiento de manera consecutiva como agentes únicos o en combinación, tanto para CPHSm, CPRCm o CRPCnm, pero deben haber recibido al menos 12 semanas de quimioterapia y ARSi o ser intolerantes a uno o a ambos
    • Progresión bioquímica / radiológica no confirmada o progresión clínica
    • Según el médico tratante y los protocolos institucionales, no existen contraindicaciones para someterse a una biopsia
    • Coagulación adecuada: INR o TP ≤ 1.5 x LSN. Los pacientes con terapia de anticoagulación continua deben cambiar a heparina de bajo peso molecular al menos una semana antes de realizar la biopsia
    • Estado funcional ECOG ≤2
    • Los sujetos deben aceptar someterse a todos los procedimientos del estudio, incluida la biopsia de tejido tumoral
    Criterio de Inclusión adicional para Cohorte A:
    • Los pacientes elegibles para la cohorte A (con HRR previamente conocido) deben haber recibido al menos un inhibidor de PARP
    Criterios de inclusión (selección)
    • Cumplir todos los criterios de inclusión de pre-selección
    • Los pacientes tienen que haber progresado cumpliendo al menos uno de los siguientes criterios:
    -Progresión de enfermedad medible según criterios RECIST 1.1
    -Progresión (ósea) gammagráfica según los criterios PCWG3
    -Un incremento ≥25% sobre el nadir de PSA, con un valor absoluto ≥2ng/ml, confirmado en una segunda determinación al menos 3 semanas después, de acuerdo a los criterios PCWG3
    -Función hematológica adecuada: recuento de plaquetas ≥100.000/mm3, recuento absoluto de neutrófilos (RAN) ≥1.500/mm3, hemoglobina ≥9g/dL sin recibir más de una transfusión en las últimas 4 semanas
    •Función hepática adecuada: ALT o AST ≥2.5 por encima del límite superior normal (LSN), bilirrubina (total) ≥2 x LSN, o ≤ 5 veces el LSN si hay metástasis hepáticas
    -Función renal adecuada: para pacientes con creatinina sérica >1.5 x LSN el cálculo de aclaramiento de creatinina tiene que ser >30 ml/min (método de Gault and Cockroft)
    • Los sujetos capaces de mantener relaciones sexuales y, por lo tanto, de engendrar hijos, deben aceptar utilizar un método anticonceptivo eficaz durante la duración del ensayo y 6 meses después de la última dosis
    E.4Principal exclusion criteria
    Pre-screening Exclusion Criteria:
    • Prior treatment with PARP-inhibitors, except for those patients eligible for Cohort A
    Exclusion Criteria (screening):
    • Pre-screening exclusion criteria
    • Previous cancer diagnosis, except those patients who had a localized malignant tumor and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ or non-muscle invasive bladder cancer (NIMBC) who has had definitively curative treatment
    • Any prior medical history that according to the judgement of the investigator might interfere with the subject’s granting of informed consent or the safe execution of the procedures required in the study
    • Other serious illness(es) involving cardiac, respiratory, central nervous system, renal, hepatic or haematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
    • Uncontrolled progressive thrombo-embolic disease or active uncontrolled infection
    • Grade > 1 peripheral neuropathy or any prior/concurrent toxicity which may interfere with the safety assessment or lead to premature carboplatin discontinuation
    • Known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids
    • Hypersensitivity to carboplatin or any compound containing platinum
    • Use of systemic chemotherapeutic (including but not limited to taxanes), hormonal, biologic, or radionuclide therapy for treatment of metastatic prostate cancer (other than approved bone-targeting agents and GnRH agonist/antagonist) or any other investigational agent within 4 weeks or 5 times drug median half-life if shorter before Day 1
    • Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy (ie, platinum-derivatives, mitoxantrone, cyclophosphamide), except if for non-prostate cancer indication and last dose > 5 years prior to randomization
    • Patients with previous ≥25 % bone marrow irradiation within the 4 weeks prior to planned start of treatment
    • Major surgery within 28 days prior to the first dose of Carboplatin
    • Known Hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody or HIV
    • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    Criterios de exclusión de pre-selección
    • Haber recibido tratamiento previo con inhibidor de PARP, excepto para aquellos pacientes elegibles para la cohorte A
    Criterios de exclusion (screening)
    • Criterios de Exclusión de pre-selección
    • Diagnósticos previos de cáncer, excepto aquellos pacientes que tuvieron un tumor maligno localizado y se encuentran libres de enfermedad después de 5 años, así como sujetos con antecedentes de tumor de piel (de estirpe no melanoma), carcinomas in situ resecados o cáncer vesical no músculo invasivo con tratamiento radical con intención curativa
    • Cualquier antecedente medico previo que a criterio del investigador pudiera interferir con el otorgamiento de consentimiento informado o la ejecución segura de los procedimientos requeridos en el estudio
    • Otras enfermedades graves relacionadas con los sistemas cardíacos, respiratorio, sistema nervioso central, renal, hepático o hematológico que pudieran impedir la finalización de este estudio o interferir con la determinación de la causalidad de cualquier efecto adverso ocurrido en el estudio
    • Enfermedad tromboembólica progresiva incontrolada o infección activa no controlada
    • Neuropatía periférica de grado > 1 o cualquier toxicidad previa / concurrente que pueda interferir con la evaluación de seguridad o provocar una interrupción prematura del carboplatino
    • Metastásis cerebrales o carcinomatosis leptomeningea conocida, a menos que se encuentre clínicamente estable y con una dosis estable de esteroides
    • Hipersensibilidad a carboplatino o a cualquier compuesto que contenga platino
    • Uso de quimioterapia sistémica (incluidos, entre otros, taxanos), terapia biológica, con radionúclidos o terapia hormonal para el tratamiento del cáncer de próstata metastásico (exceptuando el uso de agentes protectores del hueso y de agonistas / antagonistas de LH-RH) o cualquier otro producto de investigación administrado dentro de las 4 semanas previas al día 1 o 5 veces la semivida media del fármaco previas al día 1, si esta es más corta
    • Sujetos que recibieron algún tratamiento previo con quimioterapia citotóxica que pueda dañar el ADN (es decir, derivados del platino, mitoxantrona, ciclofosfamida), exceptuando otras indicaciones (no para cáncer de próstata) y si la última dosis fue administrada >5 años antes del inicio de tratamiento
    • Pacientes que hayan recibido irradiación de médula ósea ≥25% dentro de las 4 semanas anteriores al inicio del tratamiento
    • Realización de una cirugía mayor dentro de los 28 días previos a la primera dosis de carboplatino
    • Presencia de antígeno de superficie de la hepatitis B (HBsAg) conocido, o anticuerpos positivos contra la hepatitis C o el VIH
    • Cualquier condición psicológica, familiar, sociológica o geográfica que pueda dificultar el cumplimiento del protocolo del estudio y el calendario de seguimiento; estas condiciones deben discutirse con el paciente antes de incluirse en el ensayo
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR), as defined as a composite of biochemical and/or objective radiographic responses according to PCWG3 and RECIST v1.1
    Tasa de respuesta objetiva (RO), definida como una respuesta combinada: respuesta bioquímica y/o respuesta radiológica objetiva siguiendo los criterios del PCWG3 y RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    every 12 weeks
    cada 12 semanas
    E.5.2Secondary end point(s)
    -Number and grade of AEs according to the NCI-CTCAE v.5.0
    -TTPP: median time and CI 95% to PSA progression according to PCWG3
    -rPFS: median time and CI 95% to radiographic progression based on RECIST 1.1 and/or PCWG3 or death due to any cause, whichever occurs first
    -cPFS: median time and CI 95% to clinical progression based on the preestablished criteria for clinical progression or death due to any cause whichever occurs first
    -compPFS: median time and CI 95% to radiographic and/or clinical progression or death due to any cause, whichever occur first
    -OS: median time and CI 95% to death due to any cause
    -Número y grado de eventos adversos de acuerdo a la clasificación NCI-CTCAE v.5.0
    -TPP: Tiempo (mediana e IC 95%) hasta la progresión por PSA de acuerdo a los criterios PCWG3
    -SLPr: Tiempo (mediana e IC 95%) hasta la progresión radiológica medida por criterios RECIST 1.1, criterios PCWG3 o exitus por cualquier causa, lo que ocurra antes
    -SLPc: Tiempo (mediana e IC 95%) hasta la progresión clínica en base a criterios pre-establecidos o exitus por cualquier causa, lo que ocurra antes
    -SLPcomp: Tiempo (mediana e IC 95%) hasta la progresión radiológica y/o clínica o exitus por cualquier causa, lo que ocurra antes
    -SG: Tiempo (mediana e IC 95%) hasta el exitus debido a cualquier causa
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuous reevlaution during the study
    Reevaluación continua durante el estudio
    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 Yes
    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.8.3 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 concerned11
    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 study (EOS) will occur when the last subject has been discontinued. The EOS according to the EU Clinical Trial Directive Trial Directive will be reached when the last visit of the last subject in any center has occurred.
    El fin de estudio será cuando el últomo paciente haya discontinuado. Última visita del último paciente en cada centro
    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 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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state150
    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)
    Carboplatin will be administered for 4 cycles, except for radiographic or symptomatic progression, or unacceptable toxicity, or withdrawal of consent, or death. In presence of partial response or stable disease after 4 cycles, carboplatin can be discontinued or administered for further 2 cycles according to physician and patients’ choice. In alternative, switch to PARPi maintenance may be proposed if any of this kind of drug is approved for prostate cancer or any clinical trial becomes available
    Se administrarán 4 ciclos de carboplatino, excepto si existe progresión radiológica o clínica, toxicidad inaceptable, retirada del consentimiento o exitus. En presencia de respuesta parcial o enfermedad estable tras 4 ciclos, se podrá discontinuar carboplatino o administrar otros 2 ciclos según la decisión del investigador y del paciente. Como alternativa, se podrá proponer el inicio de tratamiento con iPARP, si hay alguno aprobado para el cáncer de próstata o si se dispone de un ensayo clínico
    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 Decision2019-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-26
    P. End of Trial
    P.End of Trial StatusOngoing
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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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