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    Summary
    EudraCT Number:2016-001248-20
    Sponsor's Protocol Code Number:COG-PRO
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-10-10
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-001248-20
    A.3Full title of the trial
    Impact of new generation hormono-therapy on cognitive functions in elderly patients treated for a metastatic prostate cancer
    Impact des hormonothérapies de nouvelles générations sur les fonctions cognitives de patients âgés traités pour un cancer de la prostate métastatique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of new generation hormono-therapy on cognitive functions in elderly patients treated for a metastatic prostate cancer
    Impact des hormonothérapies de nouvelles générations sur les fonctions cognitives de patients âgés traités pour un cancer de la prostate métastatique
    A.3.2Name or abbreviated title of the trial where available
    COG-PRO
    COG-PRO
    A.4.1Sponsor's protocol code numberCOG-PRO
    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 SponsorCentre François Baclesse
    B.1.3.4CountryFrance
    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 supportAppel d'offre Sciences Humaines et Sociales INCa
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationcentre François Baclesse
    B.5.2Functional name of contact pointAlexandra LECONTE
    B.5.3 Address:
    B.5.3.1Street Address3 avenue du Général Harris
    B.5.3.2Town/ cityCAEN cedex 5
    B.5.3.3Post code14076
    B.5.3.4CountryFrance
    B.5.4Telephone number330231455002
    B.5.5Fax number330231455158
    B.5.6E-maila.leconte@baclesse.unicancer
    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 holderAstellas Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameEnzalutamide
    D.3.4Pharmaceutical form Capsule
    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 number160
    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 ZYTIGA
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameAcetate d'abiratérone
    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 ACETATE
    D.3.9.1CAS number 154229-18-2
    D.3.9.3Other descriptive nameABIRATERONE ACETATE
    D.3.9.4EV Substance CodeSUB31647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    Cancer de la prostate métastatique
    E.1.1.1Medical condition in easily understood language
    Metastatic prostate cancer
    Cancer de la prostate métastatique
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 incidence of cognitive dysfunctions and cognitive complaints among elderly men after 3 months of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer (CRPCa)
    Evaluer l’incidence des troubles cognitifs et de la plainte cognitive de patients âgés traités par une nouvelle génération d’hormonothérapie (acétate d’abiraterone ou enzalutamide) pour un cancer de la prostate métastatique résistant à la castration (CRPCa).
    E.2.2Secondary objectives of the trial
    - To compare the impact on cognitive functions of the 2 new available hormonal agents (abiraterone acetate and enzalutamide)
    - To evaluate the impact of cognitive impairment on quality of life, autonomy and adherence to treatment
    - To evaluate the relationship between objective cognitive dysfunctions and self-reported complaints of the patients, taking into account their cognitive reserve, anxiety, depression, and fatigue
    - To evaluate the relationship between co-morbidities and cognitive dysfunctions
    - Evaluer l’impact des troubles cognitifs sur la qualité de vie, l’autonomie et l’adhésion au traitement,
    - Evaluer les relations entre dysfonctionnement cognitif objectif et subjectif, en prenant en compte l’anxiété, la dépression, la fatigue, la réserve cognitive et les comorbidités des patients,
    - Comparer l’impact de 2 nouveaux agents d’hormonothérapie sur la cognition,
    - Evaluer les relations entre comorbidités et troubles cognitifs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For the group of patients of interest -:
    -Patient must have a metastatic castration-resistant prostate cancer (CRPCa)
    -Patient must be 70 years and more
    -OMS 0-2
    -Patient must have not received chemotherapy,
    -Patient must have been already treated with first generation of ADT (androgen deprivation therapy)
    -Patient must be asymptomatic or pauci-symptomatic (with pain control, Visual Analog Scale - VAS ≤ 3)
    -Patient must be candidate for a treatment by a new generation hormono-therapy (with abiraterone acetate or enzalutamide), in combination with ADT

    For control group of patients :
    -Patient with metastatic prostate cancer without resistance to castration
    -Patient must be 70 years and more
    -OMS 0-2
    -Patient must have not received chemotherapy,
    -Patient must have already started the first generation of ADT at least since 3 months

    For the control group of healthy volunteers:
    -Man
    -No history of cancer,
    -70-year old or more,
    -Health status consistent with the participation to the study
    pour le groupe de patients d’intérêt :
    -Patient présentant un cancer de la prostate métastatique résistant à la castration
    -Patient âgé de 70 ans ou plus
    -OMS 0-2
    -Patient n’ayant pas été traité par chimiothérapie
    -Patient ayant été traité avec une hormonothérapie anti-androgénique de première génération
    -Patient asymptomatique ou pauci-symptomatique (avec contrôle de la douleur avec l’échelle visuelle analogique – EVA ≤ 3)
    -Patient candidat à une hormonothérapie de nouvelle génération (acétate d’abiratérone ou enzalutamide), en association avec l’hormonothérapie anti-androgénique

    Pour le groupe de patients contrôle :
    -Patient présentant un cancer de la prostate métastatique résistant à la castration avec absence de résistance à la castration
    -Patient âgé de 70 ans ou plus
    -OMS 0-2
    -Patient n’ayant pas été traité par chimiothérapie
    -Patient traité par hormonothérapie anti-androgénique de première génération depuis au moins 3 mois

    Pour le groupe de sujets sains:
    -Sujet masculin
    -Sujet sans antécédent de cancer
    -Sujet âgé de 70 ans ou plus
    -Etat général compatible avec la participation à l’étude
    E.4Principal exclusion criteria
    For all participants (group of patients of interest, control group of patients and group of healthy volunteers):
    -Neurological history (neurological sequelae of: traumatic brain injury, stroke, multiple sclerosis, epilepsy, neuro-degenerative disease…)
    -Known evolutive psychiatric disorder
    -Drug use
    -Heavy drinking
    -Assessed to be unable or unwilling to comply with the requirements of the protocol
    Critères communs aux 3 groupes : groupe de patients d’intérêt, de patients contrôle et de sujets sains:
    -Antécédent neurologique (séquelles neurologiques d’un traumatisme crânien, accident vasculaire cérébral, SEP, épilepsie, pathologie neuro-dégénérative…)
    -Troubles de la personnalité et de pathologie psychiatrique évolutive connue
    -Usage de drogue
    -Consommation abusive d’alcool
    -Impossibilité de se soumettre au suivi de l’essai
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of elderly patients receiving the new generation hormone-therapy who will experience a decline in cognitive performances (at least for one cognitive function) within 3 months after inclusion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months after inclusion
    E.5.2Secondary end point(s)
    According to the standardized validated tools that will be used, the secondary criteria will be based on the quantitative scores, discretized in some cases:
    - cognitive functions (objective cognitive performances and self-reported complaint)
    - quality of life
    - anxiety and depression
    - fatigue
    - autonomy
    - adherence to hormone-therapy
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 12 months after inclusion
    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 No
    E.6.4Safety No
    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 Yes
    E.6.13.1Other scope of the trial description
    Evaluation of cognitive functions
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 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
    End visit à 12 months after inclusion
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 222
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state222
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 222
    F.4.2.2In the whole clinical trial 222
    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
    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 Decision2016-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-12
    P. End of Trial
    P.End of Trial StatusOngoing
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