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    Summary
    EudraCT Number:2019-001302-15
    Sponsor's Protocol Code Number:BIO-CT-001
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-25
    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 ConcernedGreece - EOF
    A.2EudraCT number2019-001302-15
    A.3Full title of the trial
    Phase III study of Positron/Computerized Tomography (PETCT) with F-18-PSMA-1007 versus F-18-Fluorocholine to compare the detection rate of prostate cancer lesions in patients with biochemical recurrence after previous definite treatment for the primary localized tumor
    Μελέτη φάσης ΙΙΙ της Ποζιτρονικής/Υπολογιστικής Τομογραφίας ( PETCT) με Φθόριο18-Ειδικό Μεμβρανικό Προστατικό Αντιγόνο-1007 (18F-PSMA1007) έναντι της Φθόριο18-Χολίνης (18F-Choline) για τη σύγκριση του ποσοστού ανίχνευσης αλλοιώσεων καρκίνου προστάτη σε ασθενείς με βιοχημική υποτροπή μετά από προηγηθείσα οριστική θεραπεία για την αρχική εντόπιση
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Positron/Computerized Tomography (PET/CT) with 18F-PSMA1007 versus 18F-Choline to compare the detection rate of prostate cancer relapse after definite treatment
    Μελέτη της Ποζιτρονικής/Υπολογιστικής Τομογραφίας (PET/CT) με 18F-PSMA1007 έναντι 18F-Choline για τη σύγκριση του ποσοστού ανίχνευσης υποτροπών καρκίνου του προστάτη που είχε θεραπευθεί.
    A.4.1Sponsor's protocol code numberBIO-CT-001
    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 SponsorBIOKOSMOS S.A.
    B.1.3.4CountryGreece
    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 supportBIOKOSMOS S.A.
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBIOKOSMOS S.A.
    B.5.2Functional name of contact pointIoannis Emmanouilidis
    B.5.3 Address:
    B.5.3.1Street AddressPanormos Area
    B.5.3.2Town/ cityLavrio
    B.5.3.3Post code19500
    B.5.3.4CountryGreece
    B.5.4Telephone number00302292063900
    B.5.5Fax number00302292069235
    B.5.6E-mailsales@biokosmos.eu
    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 name18F-labeled prostate-specific membrane antigen-1007
    D.3.2Product code 18F-PSMA-1007
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name [18F]CHOLINE/BIOKOSMOS
    D.2.1.1.2Name of the Marketing Authorisation holderBIOKOSMOS S.A.
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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] FLUOROCHOLINE
    D.3.2Product code 18F-CHOLINE
    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 recurrent
    Υποτροπιάζων Καρκίνος Προστάτη
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    Καρκίνος του Προστάτη
    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 10036911
    E.1.2Term Prostate cancer recurrent
    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
    To show, in an independent assessment by 2 readers blinded to clinical data and tracer, the
    superiority of 18-F-PSMA-1007 over 18-F-Fluorocholine regarding the detection rate of
    metastatic prostate cancer lesions (patient-based analysis)
    Να δείξει, σε μια ανεξάρτητη αξιολόγηση από 2 αξιολογητές τυφλούς στα κλινικά δεδομένα και το ραδιοφάρμακο, την ανωτερότητα του 18F-PSMA-1007 σε σχέση με την 18F-φθοριοχολίνη όσον αφορά το ποσοστό ανίχνευσης μεταστατικών αλλοιώσεων καρκίνου του προστάτη (ανάλυση με βάση τον ασθενή)
    E.2.2Secondary objectives of the trial
    1. To compare the detection rate of the clinical investigator for F-18-PSMA-1007 and F-18-
    Fluorocholine for metastatic prostate cancer lesions (patient-based analysis)
    2. To assess sensitivity, specificity, accuracy, positive and negative predictive value of F-18-
    PSMA-1007 and F-18-Fluorocholine for prostate cancer lesions (region-based analysis:
    prostate bed, pelvic lymph nodes, extra-pelvic lymph nodes, bone, organ metastases; reads by
    investigator and 3 independent blinded readers)
    3. To assess the impact on diagnostic thinking, therapeutic decision making, and adequacy of
    therapy changes (F-18-PSMA-1007 and F-18-Fluorocholine)
    4. To assess the safety profile of F-18-PSMA-1007
    1. Να συγκρίνει το ποσοστό ανίχνευσης από τον κλινικό ερευνητή των μεταστάσεων καρκίνου προστάτη με 18F-PSMA-1007 έναντι 18F-φθοριοχολίνης (ανάλυση με βάση τον ασθενή)
    2. Να εκτιμηθεί η ευαισθησία, η ειδικότητα, η ακρίβεια, η θετική και η αρνητική προγνωστική αξία των 18F-PSMA-1007 και 18F-Φθοριοχολίνης για αλλοιώσεις του καρκίνου του προστάτη (ανάλυση με βάση την εντόπιση: κοιλότητα προστάτη, λεμφαδένες πυέλου, εξω-πυελικοί λεμφαδένες, οστά, μεταστάσεις οργάνων. Γνωμάτευση από τον ερευνητή και 2 ανεξάρτητους αξιολογητές)
    3. Να αξιολογηθεί η επίπτωση στη διάγνωση, τη λήψη θεραπευτικών αποφάσεων και την επάρκεια θεραπευτικών αλλαγών (18F-PSMA-1007 και 18F-Φθοριοχολίνη)
    4. Να αξιολογήσει το προφίλ ασφάλειας του 18F-PSMA-1007
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male with original diagnosis of prostate carcinoma with prior definitive therapy
    2. Suspicion of recurrence (3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above
    nadir after radiotherapy or cryotherapy and/or PSA rise by greater than 0.2 ng/mL after
    prostatectomy)
    3. Life expectancy of 6 months or more as judged by the investigator
    4. Willing and able to undergo all study procedures
    5. Informed consent in writing (dated and signed)
    1. Άνδρες με διάγνωση πρωτοπαθούς καρκίνου του προστάτη και προηγούμενη οριστική θεραπεία
    2. Υποψία υποτροπής (3 διαδοχικές αυξήσεις PSA και/ή αύξηση PSA κατά 2.0 ng/mL ή περισσότερο πάνω από την κατώτατη τιμή μετά από ακτινοθεραπεία ή κρυοθεραπεία και / ή αύξηση PSA περισσότερο από 0.2 ng/mL μετά από προστατεκτομή)
    3. Προσδόκιμο ζωής 6 μηνών ή περισσότερο, όπως κρίνεται από τον ερευνητή
    4. Ασθενείς πρόθυμοι και ικανοί να υποβληθούν σε όλες τις διαδικασίες της μελέτης
    5. Έγγραφη ενημερωμένη συγκατάθεση (με ημερομηνία και υπογραφή)
    E.4Principal exclusion criteria
    1. Age: less than18 years
    2. Contraindications for F-18-Fluorocholine
    3. Contraindications for any of the ingredients of F-18-PSMA-1007
    4. Close affiliation with the investigational site; e.g. first-degree relative of the investigator
    5. Participating in another therapeutic clinical trial or has completed study participation in
    another therapeutic clinical trial within 5 days of enrolment into this trial
    6. Having been previously enrolled in this clinical trial
    7. Mental conditions rendering the subject incapable to understand the nature, scope, and
    consequences of the trial
    8. Being clinically unstable or requiring emergency treatment
    1. Ηλικία: κάτω των 18 ετών
    2. Αντενδείξεις για 18F-φθοριοχολίνη
    3. Αντενδείξεις για οποιοδήποτε από τα συστατικά του 18F-PSMA-1007
    4. Στενή συνεργασία με το ερευνητικό κέντρο. π.χ. πρώτου βαθμού συγγενής του ερευνητή
    5. Συμμετοχή σε άλλη θεραπευτική κλινική μελέτη ή ολοκλήρωση συμμετοχής σε άλλη θεραπευτική κλινική μελέτη εντός 5 ημερών από την ένταξη σε αυτή τη δοκιμή
    6. Προηγούμενη ένταξη σε αυτή την κλινική δοκιμή
    7. Διανοητικές καταστάσεις που καθιστούν το άτομο ανίκανο να κατανοήσει τη φύση, το πεδίο και τις συνέπειες της μελέτης
    8. Κλινικά ασταθής ασθενής ή ασθενής που απαιτεί επείγουσα θεραπεία
    E.5 End points
    E.5.1Primary end point(s)
    Detection rate of prostate cancer lesions (patient-based, independent read).
    Ποσοστό ανίχνευσης των αλλοιώσεων του καρκίνου του προστάτη (με βάση τον ασθενή, ανεξάρτητη αξιολόγηση).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the two PET/CT scans
    Μετά το πέρας των δύο απεικονιστικών εξετάσεων ποζιτρονικής /υπολογιστικής τομογραφίας
    E.5.2Secondary end point(s)
    1. Detection rate of prostate cancer lesions
    (patient-based: local investigator)
    2. Per body region: sensitivity and specificity for detection of prostate cancer lesions (expert
    panel assessment as standard of truth)
    3. Diagnostic thinking and therapeutic decisions (local investigators and independent experts)
    4. Appropriateness of therapeutic decisions
    5. Adverse events
    1. Ποσοστό ανίχνευσης βλαβών του καρκίνου του προστάτη (με βάση τον ασθενή: τοπικός ερευνητής)
    2. Ανά περιοχή σώματος: ευαισθησία και ειδικότητα για την ανίχνευση βλαβών του καρκίνου του προστάτη (αξιολόγηση της ομάδας εμπειρογνωμόνων ως πρότυπο της αλήθειας)
    3. Διαγνωστικές σκέψεις και θεραπευτικές αποφάσεις (τοπικοί ερευνητές και ανεξάρτητοι εμπειρογνώμονες)
    4. Καταλληλότητα των θεραπευτικών αποφάσεων
    5. Ανεπιθύμητα συμβάντα
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study
    Μετά την ολοκλήρωση της μελέτης
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.2.3.1Comparator description
    [18F] FLUOROCHOLINE
    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 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
    Τελευταία Επίσκεψη Τελευταίου Ασθενούς
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 114
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 76
    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 state190
    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)
    Ν/Α
    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 Decision2019-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-13
    P. End of Trial
    P.End of Trial StatusOngoing
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