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    Summary
    EudraCT Number:2020-003958-67
    Sponsor's Protocol Code Number:CAAA405A12302
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-17
    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 number2020-003958-67
    A.3Full title of the trial
    Phase II/III study for evaluation of the diagnostic performance of [18F]CTT1057 PET imaging for the detection of PSMA positive tumors using histopathology as a standard of truth (GuideView)
    Etude de phase II/III évaluant la performance diagnostique de la tomographie par émission de positons avec [18F]CTT1057 dans la détection des tumeurs positives à l’antigène membranaire spécifique de la prostate en utilisant l’histopathologie comme comparateur de référence (GuideView)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diagnostic performance of [18F]CTT1057 PET versus pathology
    Performance diagnostique de la tomographie par émission de positons avec [18F] CTT1057 versus pathologie
    A.3.2Name or abbreviated title of the trial where available
    GuideView
    A.4.1Sponsor's protocol code numberCAAA405A12302
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma S.A.S
    B.5.2Functional name of contact pointInformation&Communication Médicales
    B.5.3 Address:
    B.5.3.1Street Address8/10 rue Henry Sainte Claire Deville
    B.5.3.2Town/ cityRueil-Malmaison
    B.5.3.3Post code92500
    B.5.3.4CountryFrance
    B.5.4Telephone number+3315547 6600
    B.5.5Fax number+3315547 6100
    B.5.6E-mailicm.phfr@novartis.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 name[18F]CTT1057
    D.3.2Product code AAA405
    D.3.4Pharmaceutical form Solution for injection
    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 INNnot yet available
    D.3.9.2Current sponsor codeAAA405
    D.3.9.3Other descriptive name(2S)-2-[[[(4S)-4-carboxy-4-[[(4S)-4-carboxy-4-[6-[(4-(18F)fluoranylbenzoyl)amino]hexanoylamino]butanoyl]amino]butoxy]-hydroxyphosphoryl]amino]pentanedioic acid
    D.3.9.4EV Substance CodeSUB221208
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number370
    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
    Untreated high risk prostate cancer
    Cancer de la prostate à haut risque non traité
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    Cancer de la prostate
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10036918
    E.1.2Term Prostate cancer stage II
    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
    The co-primary objectives of this study are
    • to evaluate the patient-level sensitivity of [18F]CTT1057 [evaluated for all patients]
    • to evaluate the region-level specificity of [18F]CTT1057 [evaluated for all regions]
    Les principaux objectifs de cette étude sont:
    • d'évaluer la sensibilité de [18F]CTT1057 au niveau patient [cette évaluation concernera tous les patients].
    • d'évaluer la spécificité de [18F]CTT1057 au niveau région ; [cette évaluation concernera toutes les régions anatomiques].
    E.2.2Secondary objectives of the trial
    • Evaluate the patient-level specificity of [18F]CTT1057 [evaluated for all patients]
    • Evaluate the patient-level positive predictive value of [18F]CTT1057
    • Evaluate the patient-level negative predictive value of [18F]CTT1057
    • Evaluate the patient-level accuracy of [18F]CTT1057 [evaluated for all patients]
    • Evaluate the region-level sensitivity of [18F]CTT1057 for patients excluding micro-metastasis
    • Evaluate the region-level sensitivity of [18F]CTT1057
    • Evaluate the region-level positive predictive value of [18F]CTT1057
    • Evaluate the region-level negative predictive value of [18F]CTT1057
    • Evaluate the region-level accuracy of [18F]CTT1057 evaluated for all regions
    • Detection of distant metastasis in PS patients evaluated for all regions
    • Characterize the safety and tolerability of [18F]CTT1057
    • [18F]CTT1057 scan inter-reader variability
    • [18F]CTT1057 scan intra-reader variability

    other protocol-defined secondary objectives may apply.
    Evaluer (Ev) la spécificité de [18F]CTT1057 au niveau (niv.) patient évaluée sur l’ensemble des patients (pat)
    Ev. la val. prédict. positive (VPP) de [18F]CTT1057 au niv. pat.
    Ev. la val. prédict. négative (VPN) de [18F]CTT1057 au niv. pat.
    Ev. la précision de [18F]CTT1057 au niv. patient sur l’ensemble des pat.
    Ev. la sensibilité de [18F]CTT1057 au niv. de la région anatomique (rég.) en excluant les micro-métastases
    Ev. la sensibilité de [18F]CTT1057 au niv. de la rég.
    Ev. la VPP de [18F]CTT1057 au niv. de la rég.
    Ev. la VPN de [18F]CTT1057 au niv. de la rég.
    Ev. la précision de [18F]CTT1057 au niv. de la rég. sur l’ensemble des rég.
    Détection des métastases à distance chez des pat. atteints de cancer de la prostate aux premiers stades de la maladie, sur l’ensemble des rég.
    Caractériser l’innocuité et la tolérance de [18F]CTT1057
    Variabilité inter-lecteur dans l'interp. des images obten. avec [18F]CTT1057
    Variabilité intra-lecteur dans l'interp. des images obtenues avec [18F]CTT1057
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Untreated high risk biopsy-proven PCa patients according to D’Amico classification (Stage T2c or PSA level >20ng/ml or Gleason score ≥8)
    2. Scheduled or planned radical prostatectomy and extended pelvic lymph node resection up to 6 weeks after the investigational PET/CT scan followed by histopathology assessment
    3. ECOG performance status 0-2
    4. Signed informed consent must be obtained prior to participation in the study
    5. Participants must be adults ≥ 18 years of age
    1. Patients atteints de cancer de la prostate à haut risque non traité confirmé par une biopsie, selon la classification de D’Amico (stade T2c ou taux d’antigène spécifique de la prostate [PSA, pour prostate-specific antigen] > 20 ng/ml ou score de Gleason ≥ 8).
    2. Prostatectomie totale et curage ganglionnaire pelvien étendu programmés ou prévus jusqu’à 6 semaines après le PET-scan, suivis par une évaluation histopathologique.
    3. Indice de performance ECOG (pour Eastern Cooperative Oncology Group) entre 0 et 2.
    4. La signature du consentement éclairé doit être obtenue avant toute procédure de l’étude.
    5. Patients adultes âgés de ≥ 18 ans.
    E.4Principal exclusion criteria
    1. Inability to complete the needed investigational and standard-of-care imaging examinations due to any reason (severe claustrophobia, inability to lie still for the entire imaging time, etc.)
    2. Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation, including, but not limited to, current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, need of indwelling/condom catheters, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, and COVID-19.
    3. Known allergy, hypersensitivity, or intolerance to [18F]CTT1057
    4. Prior and current use of PSMA targeted therapies
    5. Prior and current treatment with LHRH analogues
    6. Any prior ADT (first or second generation) within 9 months before screening
    7. Any 5-alpha reductase inhibitors within 30 days before screening
    8. Patients with small cell or neuroendocrine PCa in more than 50% of biopsy tissue
    9. Patients with incidental PCa after transuretheral resection
    10. Use of other investigational drugs within 30 days before screening
    1. Incapacité à passer les examens d’imagerie expérimentale et standard requis, quelle qu’en soit la raison (par ex. claustrophobie sévère, incapacité à rester allongé sans bouger pendant toute la durée de l’examen).
    2. Toute comorbidité, maladie intercurrente grave, cancer concomitant ou autre circonstance qui indiquerait un risque significatif pour la sécurité du patient ou compromettrait sa participation à l’étude, selon le médecin-investigateur, incluant entre autres : incontinence urinaire sévère, hydronéphrose, dysfonction mictionnelle sévère, sonde urinaire à demeure/condom urinaire, insuffisance cardiaque congestive de classe III ou IV selon la New York Heart Association, antécédents de syndrome du QT long congénital, infection non contrôlée, hépatite B ou C active, COVID-19.
    3. Allergie, hypersensibilité ou intolérance connue au [18F]CTT1057.
    4. Traitement antérieur ou en cours ciblant le PSMA.
    5. Traitement antérieur ou en cours par des analogues de la LHRH (pour luteinizing hormone-releasing hormone).
    6. Tout traitement anti-androgénique antérieur (première ou deuxième génération) dans les 9 mois précédant la sélection.
    7. Tout traitement inhibiteur de la 5-alpha réductase dans les 30 jours précédant la sélection.
    8. Patients présentant un cancer de la prostate à petites cellules ou neuroendocrine dans plus de 50 % des tissus prélevés par biopsie.
    9. Patients présentant un cancer de la prostate secondaire à une résection transurétrale.
    10. Utilisation de tout autre traitement expérimental dans les 30 jours précédant la sélection.
    E.5 End points
    E.5.1Primary end point(s)
    • Sensitivity of [18F]CTT1057 PET imaging, considering PSMA positive patients those who show at least one pathological [18F]CTT1057 uptake either in the primary tumor and/or metastatic pelvic lymph nodes (PLN) regions, with anatomically localized correspondence with the SoT.

    • Specificity of [18F]CTT1057 PET imaging, defined as proportion of regions that test negative for lymph nodes on [18F]CTT1057 among those that are lymph node negative on the SoT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For both co-primary endpoints [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan.
    E.5.2Secondary end point(s)
    • Specificity of [18F]CTT1057 PET imaging, considering PSMA negative patients those who do not show any pathological [18F]CTT1057 uptake either in the primary tumor or metastatic lymph nodes and will be confirmed not having primary tumor or metastatic lymph nodes with the SoT
    • Proportion of patients who are both [18F]CTT1057 and SoT positive (true positives (TP) among those who test positive on [18F]CTT1057 (TP+ false positives(FP))
    • Proportion of patients who are both [18F]CTT1057 and SoT negative (true negatives (TN)) among those who test negative on [18F]CTT1057 (TN+ false negatives (FN))
    • Proportion of patients that are SoT and [18F]CTT1057 positive (TP) and negative (TN) among all patients enrolled (TP+TN+FP+FN)
    • Sensitivity of [18F]CTT1057 PET imaging in the PLN region, excluding from the analysis those lymph nodes showing metastasis <2mm (micro-metastasis)
    • Proportion of PLN regions that test positive on both [18F]CTT1057 and SoT (TP) among those that are SoT positive (TP+FN)
    • Proportion of PLN regions that are SoT and [18F]CTT1057 positive (TP) among those regions that test positive on [18F]CTT1057 (TP+FP)
    • Proportion of PLN regions that are SoT and [18F]CTT1057 negative (TN) among those regions that test negative on [18F]CTT1057 (TN+FN)
    • Proportion of PLN regions that are SoT and [18F]CTT1057 positive (TP) and negative (TN) among all PLN regions assessed [18F]CTT1057 (TP+TN+FP+FN)
    • Number of distant metastasis identified at PET/CT scan in all patients, and percentage of patients with at least one lesion outside the prostate (primary tumor) identified by PET/CT scan
    • Incidence of AEs after PET tracer injection, after PET/CT scan and at 24-72 h after PET/CT scan. Treatment emergent adverse event (TEAE) rate within 14 days of administration
    • Inter-reader agreement of [18F]CTT1057 images
    • Intra-reader agreement of [18F]CTT1057 images
    • Summary statistics of [18F]CTT1057 pharmacokinetic parameters (i.e. Cmax, Tmax, AUClast, AUCinf, T1/2, Vz and CL from blood radioactivity data; quantification of urinary excretion of [18F]CTT1057 from urine data)
    E.5.2.1Timepoint(s) of evaluation of this end point
    For majority of secondary endpoints [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan.

    PK blood and urine collection will be performed at Day 1 at various scheduled timepoints.

    Safety endpoints will be collected from up to 28 days prior study medication administration to 14 days after study medication administration.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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
    Tolerability
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    multi-center, single-arm, open-label prospective study
    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.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    France
    Italy
    Spain
    Switzerland
    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
    Study completion is defined as when the last participant finishes the last visit for the study or, in the event of an early study termination decision, the date of that decision.
    La fin de l'étude est définie quand le dernier patient a terminé sa dernière visite pour l'étude, ou en cas de décision d'arrêt précoce de l'étude, la date de cette décision.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial 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: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 137
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 133
    F.4.2.2In the whole clinical trial 195
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-24
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