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    Summary
    EudraCT Number:2008-008004-41
    Sponsor's Protocol Code Number:COU-AA-302
    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:2009-08-11
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2008-008004-41
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients with Metastatic Castration-Resistant Prostate Cancer.
    Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo di abiraterone acetato (CB7630) piu` prednisone in pazienti asintomatici o lievemente sintomatici affetti da carcinoma prostatico metastatico refrattario alla castrazione.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients with Metastatic Castration-Resistant Prostate Cancer.
    Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo di abiraterone acetato (CB7630) piu` prednisone in pazienti asintomatici o lievemente sintomatici affetti da carcinoma prostatico metastatico refrattario alla castrazione.
    A.3.2Name or abbreviated title of the trial where available
    COU-AA-302
    COU-AA-302
    A.4.1Sponsor's protocol code numberCOU-AA-302
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00887198
    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 SponsorJANSSEN-CILAG INTERNATIONAL N.V.
    B.1.3.4CountryBelgium
    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.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovella Clinical
    B.5.2Functional name of contact pointServizio Informazione Sperimentazio
    B.5.3 Address:
    B.5.3.1Street AddressVia Crescini 76
    B.5.3.2Town/ cityPadova
    B.5.3.3Post code35126
    B.5.3.4CountryItaly
    B.5.4Telephone number+39-0496884133
    B.5.6E-mailaparisatto@novellaclinical.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 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 nameAbiraterone acetate
    D.3.2Product code CB7630
    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 INNAbiraterone acetato
    D.3.9.1CAS number 154229-18-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.IMP: 2
    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 prednisolone 5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA UK Limited, Eastbourne, BN22 9AG
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 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 INNPrednisolone
    D.3.9.1CAS number 50-24-8
    D.3.9.4EV Substance CodeSUB10018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 3
    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 Prednisolone
    D.2.1.1.2Name of the Marketing Authorisation holderRatiopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 INNPREDNISOLONE
    D.3.9.1CAS number 50-24-8
    D.3.9.4EV Substance CodeSUB10018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer.
    Pazienti asintomatici o lievemente sintomatici affetti da cancro metastatico della prostata resistente alla castrazione.
    E.1.1.1Medical condition in easily understood language
    Asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer.
    Pazienti asintomatici o lievemente sintomatici affetti da cancro metastatico della prostata resistente alla castrazione.
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10029101
    E.1.2Term Neoplasm urogenital
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the clinical benefit of abiraterone acetate plus prednisone versus placebo plus prednisone in patients with chemotherapy-naive castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly symptomatic
    Confrontare i benefici clinici di abiraterone acetato piu` prednisone vs placebo piu` prednisone in pazienti asintomatici o lievemente sintomatici naive alla chemioterapia affetti da carcinoma prostatico metastatico refrattario alla castrazione (castration-resistant prostate cancer, CRPC)
    E.2.2Secondary objectives of the trial
    To establish additional clinically relevant improvements in prostate cancer patients treated with abiraterone acetate in comparison to placebo. To characterize the safety profile of abiraterone acetate in this patient population. To characterize the pharmacokinetics of abiraterone acetate when administered concurrently with prednisone.
    Stabilire ulteriori miglioramenti clinici rilevanti nei pazienti affetti da carcinoma prostatico trattati con abiraterone acetato in confronto al placebo.Caratterizzare il profilo di sicurezza dell`abiraterone acetato in questa popolazione di pazienti.Caratterizzare la farmacocinetica di abiraterone acetato quando somministrato simultaneamente al prednisone
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet the following criteria to be enrolled in this study. 1. Willing and able to provide written informed consent 2. Written Authorization for Use and Release of Health and Research Study Information (US sites only) or Data Protection Consent (European sites only) has been obtained 3. Male aged 18 years and above 4. Histologically or cytologically confirmed adenocarcinoma of the prostate 5. Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI. If lymph node metastasis is the only evidence of metastasis, it must be ` 2 cm in diameter 6. Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria 7. Asymptomatic or mildly symptomatic from prostate cancer. A score of 0-1 on BPI-SF Question #3 (worst pain in last 24 hours) will be considered asymptomatic, and a score of 2-3 will be considered mildly symptomatic. 8. Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If the patient is being treated with LHRH agonists (patient who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study. 9. Previous anti-androgen therapy and progression after withdrawal. Patients who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment (` 4 weeks since last flutamide, ` 6 weeks since last bicalutamide or nilutamide). 10. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 11. Hemoglobin ` 10.0 g/dL independent of transfusion 12. Platelet count `100,000/`Ž`¼L 13. Serum albumin ` 3.5 g/dL 14. Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ` 60 mL/min (see Appendix 7) 15. Serum potassium ` 3.5 mmol/L 16. Liver function: i. Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert`s disease) ii. AST or ALT < 2.5 x ULN 17. Able to swallow the study drug whole as a tablet 18. Life expectancy of at least 6 months 19. Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration.
    Ogni paziente deve soddisfare i seguenti criteri per essere arruolato in questo studio. 1. Disposto a e in grado di fornire un consenso informato in forma scritta 2. Ottenimento di autorizzazione scritta all`uso e al rilascio di informazioni per studio a scopo sanitario e di ricerca (solo per siti statunitensi) o assenso di protezione dei dati (solo per siti europei) 3. Essere maschi di almeno 18 anni di eta` 4. Adenocarcinoma della prostata confermato istologicamente o citologicamente 5. Malattia metastatica documentata da scansione ossea positiva o lesioni metastatiche diverse da metastasi epatiche o viscerali su TAC, RM. Nel caso in cui l`unica prova di metastasi sia metastasi dei linfonodi, essa deve avere un diametro di `¯`‚`³ 2 cm 6. Progressione del cancro della prostata documentata dal PSA secondo PCWG2 o progressione radiografica secondo i criteri RECIST modificati 7. Soffrire di una forma asintomatica o lievemente sintomatica di cancro della prostata. Se ha attribuito un punteggio di 0-1 alla Domanda n. 3 del BPI-SF (massima intensita` del dolore nelle ultime 24 ore) sara` considerato asintomatico, mentre se ha attribuito un punteggio di 2-3 sara` considerato lievemente sintomatico. 8. Sottoposto a castrazione chirurgica o medica, con livelli di testosterone &lt; 50 ng/dl (&lt; 2,0 nM). Qualora il paziente sia trattato con LHRH-agonisti (paziente non sottoposto a orchiectomia), questa terapia deve essere stata iniziata almeno 4 settimane prima del Giorno 1 del Ciclo 1 e va proseguita per tutta la durata dello studio. 9. Terapia con anti-androgeni precedente e progressione dopo la sospensione. I pazienti sottoposti a blocco combinato degli androgeni con un anti-androgeno devono avere mostrato progressione del PSA dopo sospensione del farmaco anti-androgeno prima dell`arruolamento (` 4 settimane dall`ultima assunzione di flutamide, ` 6 settimane dall`ultima assunzione di bicalutamide o nilutamide). 10. Stato prestazionale dell`Eastern Cooperative Oncology Group (ECOG) pari a 0 o 1 11. Emoglobina ` 10,0 g/dl indipendente da trasfusione 12. Conta piastrinica `100.000/µl 13. Albumina sierica ` 3,5 g/dl 14. Creatinina sierica &lt; 1,5 x ULN o calcolo della clearence della creatinina ` 60 ml/min (cfr. Appendice 7) 15. Potassio sierico ` 3,5 mmol/l 16. Funzionalita` epatica: i. Bilirubina sierica &lt; 1,5 x ULN (ad eccezione di pazienti con sindrome di Gilbert documentata) ii. AST o ALT &lt; 2,5 x ULN 17. In grado di inghiottire intera la compressa del farmaco sperimentale 18. Aspettativa di vita di almeno 6 mesi 19. I pazienti che hanno partner in eta` fertile devono essere disposti a usare un metodo anticoncezionale che offra un`adeguata protezione la cui accettabilita` sara` determinata dallo sperimentatore principale e dallo sponsor durante lo studio e per le 13 settimane seguenti l`ultima somministrazione del farmaco sperimentale.
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from the study: 1. Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated 2. Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone bid. 3. Pathological finding consistent with small cell carcinoma of the prostate 4. Liver or visceral organ metastasis 5. Known brain metastasis 6. Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1 7. Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC 8. Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day 1 9. Radiation or radionuclide therapy for treatment of metastatic CRPC 10. Previously treated with ketoconazole for prostate cancer for greater than 7 days 11. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1 12. Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1) 13. Bicalutamide (Casodex), nilutamide (Nilandron) within 6 weeks of Cycle 1 Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1) 14. Uncontrolled hypertension (systolic BP ` 160 mmHg or diastolic BP ` 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment 15. Active or symptomatic viral hepatitis or chronic liver disease 16. History of pituitary or adrenal dysfunction 17. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline 18. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy 19. Other malignancy, except non-melanoma skin cancer, with a ` 30% probability of recurrence within 24 months 20. Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1 21. Any condition which, in the opinion of the investigator, would preclude participation in this trial.
    I pazienti che soddisfano uno dei seguenti criteri saranno esclusi dallo studio: 1. Infezione attiva o altra condizione medica che renderebbe l`impiego di prednisone/prednisolone (corticosteroide) controindicato 2. Qualsiasi condizione medica cronica che richieda un dosaggio di corticosteroide superiore a 5 mg di prednisone/prednisolone due volte al giorno. 3. Risultanza patologica coerente con carcinoma a piccole cellule della prostata 4. Metastasi epatica o degli organi viscerali 5. Metastasi cerebrale nota 6. Impiego di analgesici oppiacei per il dolore correlato al cancro, fra cui codeina e destropropossifene, somministrati attualmente o in un qualsiasi momento entro 4 settimane dal Giorno 1 del Ciclo 1 7. Chemioterapia citotossica precedente o terapia biologica per il trattamento del CRPC 8. Radioterapia per il trattamento del tumore primario entro 6 settimane dal Giorno 1 del Ciclo 1 9. Radioterapia o terapia radiometabolica per il trattamento del CRPC metastatico 10. Terapia precedente con chetoconazolo per il cancro della prostata durata piu` di 7 giorni 11. Trattamento sistemico precedente con un farmaco a base di azolo (per es. fluconazolo, itraconazolo) entro 4 settimane dal Giorno 1 del Ciclo 1 12. Trattamento precedente con flutamide (Eulexin) entro 4 settimane dal Giorno 1 del Ciclo 1 (i pazienti il cui PSA non ha mostrato riduzioni per tre o piu` mesi in risposta all`antiandrogeno somministrato quale terapia di seconda linea o a intervento successivo necessitano solo di washout di due settimane prima del Giorno 1 del Ciclo 1) 13. Bicalutamide (Casodex), nilutamide (Nilandron) entro 6 settimane dal Giorno 1 del Ciclo 1 (i pazienti il cui PSA non ha mostrato riduzioni per tre o piu` mesi in risposta all`antiandrogeno somministrato quale terapia di seconda linea o a intervento successivo necessitano solo di washout di due settimane prima del Giorno 1 del Ciclo 1) 14. Ipertensione non controllata (PA sistolica ` 160 mmHg o PA diastolica ` 95 mmHg). I pazienti con anamnesi di ipertensione sono ammessi, a condizione che la pressione sanguigna sia controllata con terapia antipertensiva 15. Epatite virale attiva o sintomatica o malattia epatica cronica 16. Anamnesi di disfunzione pituitaria o surrenale 17. Cardiopatia clinicamente significativa come mostrato da infarto miocardico, o eventi trombotici arteriosi manifestatisi negli ultimi 6 mesi, angina grave o instabile, o cardiopatia di classe II-IV della New York Heart Association (NYHA) o misurazione della frazione di eiezione &lt; 50% alla baseline 18. Fibrillazione atriale o altra aritmia cardiaca che richieda terapia 19. Altra neoplasia maligna, tranne cancro della pelle non-melanoma, con una probabilita` di recidiva ` 30% entro 24 mesi 20. Somministrazione di un agente terapeutico sperimentale entro 30 giorni dal Giorno 1 del Ciclo 1 21. Qualsiasi condizione che, secondo l`opinione dello sperimentatore, impedirebbe la partecipazione a questo studio clinico.
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary efficacy endpoints: Overall survival (OS) and radiographic progression-free survival (rPFS).
    Gli endpoint coprimari sono la sopravvivenza globale (OS) e la sopravvivenza senza progressione radiografica (rPFS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At day 1 of cycles 3, 5, 7, 10, 13, 16, 19 etc...of treatment (each cycle being 28 days).
    Il giorno 1 dei cicli 3, 5, 7, 10, 13, 16, 19 etc...del trattamento (ogni ciclo è di 28 giorni).
    E.5.2Secondary end point(s)
    Secondary efficacy assessments: time to opiate use for cancer-related pain and time to administration of cytoxic chemotherapy for metastatic prostate cancer will be prospectively assessed; EOCG performance status will be evaluated throughout the study to assess time to first deterioration; PSA values will be collected throughout the study to assess time to PSA progression
    Valutazioni di efficacia secondari: tempo di consumo di oppiacei per il dolore correlato al cancro e il tempo di somministrazione della chemioterapia citotossica per il cancro metastatico alla prostata saranno valutati prospetticamente; status EOCG saranno valutati nel corso dello studio per valutare il tempo al primo peggioramento; valori di PSA saranno raccolti nel corso dello studio per valutare il tempo di progressione del PSA
    E.5.2.1Timepoint(s) of evaluation of this end point
    EOCG status - at day 1 of cycles 1, 2, 3, 4, 5, 6 etc...of treatment (each cycle being 28 days).
    Status EOCG al giorno 1 dei cicli 1, 2, 3, 4, 5, 6 etc..del trattamento (ogni ciclo è di 28 giorni).
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA150
    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 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
    LVLS
    Il follow up continuera' per 60 mesi (5 anni) o fino alla morte del paziente o in caso di perdita del paziente al follow up o per ritiro del consenso.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months45
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months45
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    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)
    See protocol
    Vedi protocollo
    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 Decision2009-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-22
    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
    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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