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    Summary
    EudraCT Number:2020-003323-42
    Sponsor's Protocol Code Number:29BRC20.0203
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-11-30
    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 number2020-003323-42
    A.3Full title of the trial
    Diagnostic Performance of prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) imaging for Pre-operative lymph Node assessment in intermediate and high-risk prostate cancer.
    Performances diagnostiques de la tomographie par émission de positons/Tomodensitométrie (TEP/TDM) aux ligands de l’antigène membranaire spécifique de la prostate (TEP-PSMA) pour l’évaluation du statut ganglionnaire pré opératoire chez les patients présentant une néoplasie prostatique de risque intermédiaire ou élevé : une étude diagnostique contre test de référence.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diagnostic Performance of prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) imaging for Pre-operative lymph Node assessment in intermediate and high-risk prostate cancer.
    Performances diagnostiques de la tomographie par émission de positons/Tomodensitométrie aux ligands de l’antigène membranaire spécifique de la prostate pour l’évaluation du statut ganglionnaire pré opératoire chez les patients présentant une néoplasie prostatique de risque intermédiaire ou élevé : une étude diagnostique contre test de référence.
    A.3.2Name or abbreviated title of the trial where available
    PREOP-PSMA
    PREOP-PSMA
    A.4.1Sponsor's protocol code number29BRC20.0203
    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 SponsorCHRU de Brest
    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 supportCHRU de Brest
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Brest
    B.5.2Functional name of contact pointMenez
    B.5.3 Address:
    B.5.3.1Street Address2 avenue Foch
    B.5.3.2Town/ cityBrest
    B.5.3.3Post code29609
    B.5.3.4CountryFrance
    B.5.4Telephone number229020089+33
    B.5.5Fax number298223183+33
    B.5.6E-mailtiphaine.menez@chu-brest.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 name68Ga-HBED-CC-PSMA
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    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
    Prostate cancer
    Cancer de la prostate
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    Cancer de la prostate
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10036946
    E.1.2Term Prostatic cancer
    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
    The main objective of the trial is to determine the diagnostic performance of PSMA PET/CT for the detection of lymph node metastases in intermediate- and high-risk prostate cancer whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting.
    L'objectif principal de l'étude est de déterminer les performances diagnostiques de la Tomographie par Emission de Positons aux ligands de l’antigène membranaire spécifique de la prostate (TEP-PSMA) pour la détection des métastases ganglionnaires des néoplasies prostatiques de risque intermédiaire ou élevé dont le traitement radical par prostatectomie est retenu par la réunion de concertation pluridisciplinaire.
    E.2.2Secondary objectives of the trial
    - To assess the clinical impact of PSMA PET/CT in the surgical strategy of lymph node dissection, especially lymph node dissection extended to a resectable suspected area;
    - To compare MRI and PSMA PET/CT with histopathology;
    - To determine the diagnostic performance of PSMA PET/CT to detect distant metastases in patients whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting;
    - To assess the value of PSMA PET/CT dynamic (versus static) acquisition to differentiate malignant lesions from benign lesions or physiological urinary elimination;
    - To confirm the 68Ga-HBED-CC-PSMA perfect tolerance.
    ­- Évaluer l’impact clinique de la TEP-PSMA dans la stratégie chirurgicale du curage ganglionnaire, et notamment une extension du curage ganglionnaire à une zone suspecte résécable ;
    - Confronter les données d’IRM et de TEP-PSMA aux données anatomopathologiques ;
    - Déterminer les performances diagnostiques de la TEP-PSMA pour détecter des métastases viscérales ou osseuses à distance chez les patients dont le traitement radical par prostatectomie est retenu par la réunion de concertation pluridisciplinaire ;
    - Évaluer l’intérêt d’une acquisition dynamique (versus statique) des images TEP-PSMA pour différencier les lésions tumorales des lésions bénignes ou de l’élimination urinaire physiologique ;
    - Confirmer les données sur la parfaite tolérance du 68Ga-HBED-CC-PSMA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ­- Histologically confirmed prostate cancer;
    - Intermediate-risk prostate cancer (PSA level of 10- 20 ng/mL and/or Clinical tumor stage ≥ T2b and/or ISUP 2 or 3, AND with risk of lymph node extension > 5% according to the Briganti nomogram) or high-risk prostate cancer (PSA ≥ 20 ng/mL and/or TR ≥ T2c and/or ISUP 4 or 5) according to d’Amico classification;
    - Curative treatment by radical prostatectomy chosen by the multidisciplinary consultation meeting.
    ­- Néoplasie prostatique confirmée histologiquement ;
    ­- Néoplasie de risque intermédiaire (PSA entre 10 et 20 ng/mL et/ou TR retrouvant un T2b et/ou ISUP 2 ou 3, ET avec risque d’extension ganglionnaire > 5% selon le nomogramme de Briganti) ou élevé (PSA ≥ 20 ng/mL et/ou TR ≥ T2c et/ou ISUP 4 ou 5) selon la classification de d’Amico;
    ­- Traitement radical par prostatectomie totale retenu par la réunion de concertation pluridisciplinaire.
    E.4Principal exclusion criteria
    - Refusal or inability to participate in the study ;
    - Low-risk prostate cancer according to D’Amico’s classification, or an intermediate-risk but with a risk of lymph node extension <5% according to Briganti’s nomogram;
    - Curative treatment other than surgical treatment chosen;
    - Impossible to lie down for at least an hour;
    - Life expectancy < 12 months;
    - Karnofsky score < 70 or ECOG score > 2.
    ­- Refus ou impossibilité de participer à l’étude ;
    ­- Néoplasie prostatique de faible risque d’extension selon la classification de D’Amico, ou de risque intermédiaire mais avec un risque d’extension ganglionnaire <5% selon le nomogramme de Briganti ;
    ­- Traitement curatif autre que chirurgical retenu ;
    ­- Impossibilité de tenir allongé au moins 1h ;
    ­- Espérance de vie < 12 mois ;
    ­- Score de Karnofsky < 70 ou score ECOG > 2.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluate the sensitivity, specificity, and likelihood ratios of PET-PSMA for the detection of lymph node locations of intermediate- and high-risk prostatic neoplasia, in patients whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting, with reference to the gold standard obtained from histology data and/or follow-up imaging.

    The gold standard will be obtained by extensive lymph node dissection performed on 6 lymph node areas (right and left obturators, right and left internal iliacs and right and left external iliacs) defined by the French Association of Urology and the European Association of Urology.

    The PET-PSMA scan diagnosis will focus on these same lymph node areas, returning a binary (positive or negative) result for each of them.
    Evaluer la sensibilité, la spécificité, et les rapports de vraisemblance de la TEP-PSMA pour la détection des localisations ganglionnaires des néoplasies prostatiques à risque intermédiaire ou élevé, chez les patients dont le traitement radical par prostatectomie est retenu par la réunion de concertation pluridisciplinaire, par référence au gold standard obtenu par les données de l’histologie et/ou suivi d’imagerie.

    Le gold standard sera obtenu par curage ganglionnaire étendu pratiqué sur 6 aires ganglionnaires (obturatrices droite et gauche, iliaques internes droite et gauche et iliaques externes droite et gauche) définies par l’Association Française d’Urologie et par l’European Association of Urology.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mois
    E.5.2Secondary end point(s)
    - Modification of the surgical strategy of lymph node dissection based on PSMA PET/CT, compared to the strategy that would have been done by conventional imaging alone;
    - Pathological focal uptake detected on the 3 examinations (PSMA PET/CT and MRI vs. pathology = gold standard) for each of the 6 following prostate locations: base, middle, apex (right and left);
    - Sensitivity/specificity of PSMA PET/CT to detect distant metastases, using a composite standard of reference (combination of clinical data, histopathology, repeat PSA follow-up and any imaging findings obtained during usual follow-up, as available);
    - Early pelvic abnormal uptakes identified during dynamic acquisition, compared to images obtained 60 minutes after injection;
    - Parametric lesions uptakes, quantified by the PSMA uptake rate constant ki;
    - Adverse events collected during the assessment.
    - Modification de la stratégie chirurgicale du curage ganglionnaire au vu de l’examen TEP-PSMA, par rapport à la stratégie qui aurait été dictée par l’imagerie conventionnelle seule ;
    - Existence d’un foyer pathologique selon chacun des 3 examens (TEP-PSMA, IRM et anatomopathologie = gold standard) pour chacune des 6 localisations suivantes : base, milieu, apex prostatique (droite et gauche) ;
    - Sensibilité/spécificité de la TEP/PSMA dans la détection de métastases viscérales ou osseuses à distance en prenant comme gold standard le diagnostic porté par un comité de relecture au vu du suivi du patient et des résultats disponibles réalisés en pratique courante (données cliniques, anatomopathologie, dosages répétés du PSA et imagerie) ;
    - Hyperfixations pelviennes précoces identifiées en acquisition dynamiques, en regard des images obtenues 60 minutes après l’injection ;
    - Captation du radiopharmaceutique au niveau des lésions identifiées, quantifiée par le coefficient ki ;
    - Evènement indésirables recueillis lors du bilan.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 mois
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    Dernière visite du denier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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)
    It is the same as the normal treatment ot that condition
    Identique à la prise en charge habituelle
    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 Decision2021-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-01
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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