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    Summary
    EudraCT Number:2014-004296-22
    Sponsor's Protocol Code Number:2014-RdC-PRO-Th
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-12-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-004296-22
    A.3Full title of the trial
    Anticholinergics impact in the treatment of acute irritative urinary toxicity during radiotherapy for prostate cancer
    Impact des anticholinergiques dans le traitement de la toxicité urinaire irritative aiguë au cours d'une radiothérapie pour cancer de prostate
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of anticholinergic treatment on urinary discomfort during radiotherapy for prostate cancer
    Impact d'un traitement anticholinergique sur la gêne urinaire survenant au cours de radiothérapie pour cancer de prostate
    A.3.2Name or abbreviated title of the trial where available
    VesiCaP
    VesiCaP
    A.4.1Sponsor's protocol code number2014-RdC-PRO-Th
    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 Eugène Marquis
    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 supportAstellas
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportCentre Eugène Marquis
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Eugène Marquis
    B.5.2Functional name of contact pointMartine Gestin
    B.5.3 Address:
    B.5.3.1Street AddressRue de la Bataille Flandres-Dunkerque
    B.5.3.2Town/ cityRennes
    B.5.3.3Post code35042
    B.5.3.4CountryFrance
    B.5.4Telephone number33(0)299253036
    B.5.5Fax number33(0)299253234
    B.5.6E-mailm.gestin@rennes.unicancer.fr
    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 Vesicare®
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma SAS
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Coated 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 INNsolifenacin succinate
    D.3.9.1CAS number 242478-38-2
    D.3.9.3Other descriptive nameSOLIFENACIN SUCCINATE
    D.3.9.4EV Substance CodeSUB21028
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Symptomatology related to acute urinary toxicity occuring during prostate irradiation in patients suffering from prostate cancer.
    Symptomatologie relative à la toxicité urinaire aigüe survenant au cours de l’irradiation prostatique pour des patients atteints de cancer de prostate.
    E.1.1.1Medical condition in easily understood language
    Irritative urinary discomfort during irradiation in the prostate cancer treatment
    Gêne urinaire irritative survenant en cours de radiothérapie dans le traitement de cancer de prostate.
    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 18.1
    E.1.2Level HLT
    E.1.2Classification code 10004995
    E.1.2Term Bladder and urethral symptoms
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main goal of the study is to assess solifenacin succinate efficacy on irritative urinary symptomatology occuring during prostate irridiation in patients suffering from prostate cancer.
    L'objectif principal de l'étude est d’évaluer l’efficacité du traitement par succinate de solifénacine sur la symptomatologie urinaire irritative survenant au cours d'une irradiation prostatique chez
    des patients atteints d’un cancer de la prostate.
    E.2.2Secondary objectives of the trial
    To assess solifenacin succinate efficacy on non irritative symptoms and on global urinary symptomatology of patients during prostate irridiation.
    To assess solifenacin succinate efficacy on quality of live of patients having an irritative urinary syndrom during prostate irradiation.
    To describe qualitatively and quantitatively acute urinary toxicity during prostate irradiation in patients treated with anticholinergic.
    To assess solifenacin tolerance of patients during and after prostate irradiation.
    Evaluer l’efficacité du succinate de solifénacine sur les symptômes non irritatifs et la symptomatologie urinaire globale des patients durant une irradiation prostatique.
    Evaluer l’efficacité du succinate de solifénacine sur la qualité de vie des patients présentant un syndrome urinaire irritatif durant une irradiation prostatique.
    Décrire qualitativement et quantitativement la toxicité urinaire aigüe durant une irradiation prostatique chez des patients sous traitement anticholinergique.
    Evaluer la tolérance du succinate de solifénacine chez des patients en cours et après une irradiation prostatique.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Prostate localized adenocarcinoma (histological confirmation)
    - Indication for prostate cancer radiotherapy (standard scheme with a global dose between 70 and 80 Gy)
    - Patient affiliation to the French Social Security System
    - Free and written informed consent
    - Patients complaigning of urinary symptoms during irradiation
    - Occurrence of overactive bladder subscore with the USP scale greater to 5 during irradiation.
    . Adénocarcinome de la prostate localisé (avec preuve histologique).
    - Indication de radiothérapie prostatique (schéma standard avec une dose totale de 70 à 80 Gy).
    - Affiliation à un régime de sécurité social.
    - Consentement libre, éclairé et par écrit.
    - Patient se plaignant de symptômes urinaires durant l’irradiation.
    - Survenue d’un score d’hyperactivité vésicale à l’USP au cours de l’irradiation supérieur à 5.
    E.4Principal exclusion criteria
    1- Pelvic irradiation contraindication
    2- History of bladder or prostate surgery
    3- History of pelvic radiotherapy
    4- Person deprived of freedom, under tutorship,guardianship, safeguarding of justice
    5- Age < 18
    6- Qmax < 10 ml/sec at initial assessment, or post-void residual urine > 100 ml (during preinclusion urology visit)
    7- Previous known Overactive Bladder
    8- Patients treated with anticholinergic or anticholinesterasic within 12 months before irradiation
    9- Patients treated with α-blocker, 5-alpha reductase inhibitors within 12 months before irradiation,
    10- Contraindication of solifenacin succinate treatment :
    - patients suffering from urinary retention, severe gastrointestinal disease (including toxic megacolon), myasthenia or angle-closure glaucoma, as well as patients at risk against these diseases
    - patients suffering from hypersensitivity to active substance or to one of its excipients
    - hemodialyzed patients
    - patients suffering from severe hepatic insufficiency
    - patients suffering from severe renal or moderate hepatic insufficiency and who are treated with a strong inhibitor of iso-enzyme CYP3A4 as Ketoconazole
    11- Hypersensitivity or allergy to another anticholinergic
    12- Hereditary intolerance to galactose, lactase deficiency (Lapp) or syndrome of glucose and galactose malabsorption
    13- Patients unable to follow study medical requirement for family, social, geographical or psychic reasons
    14- Participation to a clinical trial on urinary toxicity and / or substance that could modify this toxicity and its evolution.
    . Contre-indication à une irradiation pelvienne.
    · Antécédents de chirurgie vésicale ou prostatique.
    · Antécédent de radiothérapie pelvienne.
    · Personne privée de liberté, sous tutelle, sous curatelle, ou sauvegarde de justice.
    · Mineurs (âge < 18 ans).
    · Qmax à la Débitmétrie <10ml/sec et/ou résidu post-mictionnel >100ml (lors d'une consultation d'urologie pré-inclusion).
    · Sujets présentant une hyperactivité détrusorienne connue.
    · Sujets traités par anticholinergiques ou anticholinestérasiques dans les 12 mois précédant l'irradiation
    · Sujets traités par α-bloquants, inhibiteurs de la 5-alpha réductase dans les 12 mois précédant l'irradiation.
    · Contre-indication à l’utilisation du Succinate de Solifenacine :
    o Patients souffrant de rétention urinaire, d'une affection gastro- intestinale sévère (dont le mégacôlon toxique), de myasthénie ou d'un glaucome par fermeture de l'angle, ainsi que les patients à risque vis-à-vis de ces affections.
    o Patients souffrant d'une hypersensibilité à la substance active ou à l'un des excipients.
    o Patients hémodialysés.
    o Patients souffrant d'une insuffisance hépatique sévère.
    o Patients souffrant d'une insuffisance rénale sévère ou d'une insuffisance hépatique modérée et qui sont traités par un puissant inhibiteur de l'iso-enzyme CYP3A4 tel que le kétoconazole.
    · Hypersensibilité ou allergie à un autre anticholinergique.
    · Intolérance héréditaire au galactose, un déficit en lactase (Lapp) ou un syndrome de malabsorption du glucose et du galactose.
    · Personne dans l’impossibilité de se soumettre au suivi médical de l’essai pour des raisons familiales, sociales, géographiques ou psychologiques.
    · Participation à un essai clinique sur la toxicité urinaire et ou une molécule pouvant modifier cette toxicité et son évolution.
    E.5 End points
    E.5.1Primary end point(s)
    The main goal of this study is to assess solifenacin succinate treatment on irritative urinary symptomatology occuring during prostate irradiation in patients suffering from prostate cancer
    L'objectif principal de l'étude est d’évaluer l’efficacité du traitement par succinate de solifénacine sur la symptomatologie urinaire irritative survenant au cours d'une irradiation prostatique chez
    des patients atteints d’un cancer de la prostate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    OAB score measured with USP scale, 6 weeks after start of anticholinergic treatment
    Le critère d’évaluation principal de l’efficacité est le score d’hyperactivité vésicale mesurée par l’échelle de mesure USP à 6 semaines du début du traitement anticholinergique.
    E.5.2Secondary end point(s)
    To assess solifenacin succinate efficacy on non irritative symptoms and global urinary symptomatology of patients during irradiation
    To assess efficacy of solifenacin succinate on quality of life of patients with irritative urinary syndrom during irradiation
    To describe qualitatively and quantitatively acute urinary toxicity during prostate irradiation of patients treated with anticholinergic
    To assess safety of solifenacin succinate of patients during and after prostate irradiation
    Evaluer l’efficacité du succinate de solifénacine sur les symptômes non irritatifs et la symptomatologie urinaire globale des patients durant une irradiation prostatique.
    Evaluer l’efficacité du succinate de solifénacine sur la qualité de vie des patients présentant un syndrome urinaire irritatif durant une irradiation prostatique.
    Décrire qualitativement et quantitativement la toxicité urinaire aigüe durant une irradiation prostatique chez des patients sous traitement anticholinergique.
    Evaluer la tolérance du succinate de solifénacine chez des patients en cours et après une irradiation prostatique.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Urinary symptoms collection by patients with a voiding calendar at initiation, 6 weeks, 3 months and 6 months after treatment start
    - "Global" and "dysuria" scores measured with USP scale at initiation, 6 weeks, 3 months and 6 months after treatment start
    - Global score measured with IPSS scale at initiation, 6 weeks, 3 months and 6 months after treatment start
    - CTCAE V4 grades of urinary symptomatology (non irritative) at initiation, 6 weeks, 3 months and 6 months after treatment start
    - Quality of life scores (QLQC30, QLQ-PR25) at initiation, 6 weeks, 3 months and 6 months after treatment start
    - Frequency and grade according CTCAE V4 scale of the whole adverse events occured during the study
    · Le recueil des symptômes urinaires par le patient à l’aide d’un calendrier mictionnel à l'initiation, 6 semaines, 3 mois et 6 mois du début du traitement.
    · Score « global » et score « dysurie » mesurés par l’échelle USP à l’initiation, 6 semaines, 3 mois et 6 mois du début du traitement.
    · Score global mesuré par l’échelle IPSS à l’initiation, 6 semaines, 3 mois et 6 mois du début du traitement.
    · Les grades CTCAE V4 de la symptomatologie urinaire (non irritative) à l’initiation, 6 semaines, 3 mois et 6 mois du début du traitement anticholinergique.
    · Scores de qualité de vie (QLQ-C30, QLQ-PR25) à l'initiation, 6 semaines, 3 mois et 6 mois du début du traitement.
    · Fréquence et grade selon l’échelle CTCAE V4 de l’ensemble des évènements indésirables survenus pendant l’étude.
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned3
    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
    LVLS
    Dernière visite du dernier patient inclus
    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 months4
    E.8.9.1In the Member State concerned 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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Aucun
    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 Decision2015-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-05-02
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