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    Summary
    EudraCT Number:2018-001267-22
    Sponsor's Protocol Code Number:65593
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-06-11
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-001267-22
    A.3Full title of the trial
    F18-PSMA-1007 PET for early biochemical recurrence of prostate cancer, comparison with 18F-Fluciclovine.
    F18-PSMA-1007 PET voor vroege detectie van een biochemisch recidief van prostaatkanker, vergelijking met 18F-Fluciclovine.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    F18-PSMA-1007 PET for early biochemical recurrence of prostate cancer.
    F18-PSMA-1007 PET voor vroege detectie van een biochemisch recidief van prostaatkanker.
    A.4.1Sponsor's protocol code number65593
    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 SponsorRadboud University Medical Center
    B.1.3.4CountryNetherlands
    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 supportRadboud Translational Medicine BV
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportABX advanced biochemical compounds
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Medical Center
    B.5.2Functional name of contact pointDr. M.J.R. Janssen
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein zuid 10
    B.5.3.2Town/ cityNIjmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310243615306
    B.5.6E-mailMarcel.Janssen@radboudumc.nl
    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]F-PSMA-1007
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INN[18F]F-PSMA-1007
    D.3.9.3Other descriptive name[18F]F-PSMA-1007
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/kg megabecquerel(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Patients treated for non-metastasized prostate cancer with a biochemical recurrence of prostate cancer
    Patienten die behandeld worden voor niet-gemetastaseerd prostaatkanker met een biochemisch recidief van prostaatkanker.
    E.1.1.1Medical condition in easily understood language
    Prostate cancer.
    Prostaatkanker.
    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
    Main objective is to compare detection efficacy of 18F-PSMA-1007 PET-CT to 18F-Fluciclovine, in patients with early biochemical recurrence of prostate cancer with low PSA-levels (0.2-5.0 ug/L).
    Het belangrijkste doel van de studie is het vergelijken van de detectiegevoeligheid van 18F-PSMA-1007 PET-CT met 18F-fluciclovine PET-CT voor het detecteren van prostaatkanker lesies bij patiënten met een vroeg biochemisch recidief met lage PSA waarden (0,2-5,0 ug/L).
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    1. Comparing specificity, where the golden standard is defined by an expert panel using data of both PET-CT’s and 6 months follow up data.
    2. Analysis of the sensitivity per area (local recurrence, locoregional lymph nodes, distant lymph nodes, bone metastases, other location)
    3. Quantitative analyses: SUV measurements, tumor-background ratio’s.
    Secundaire doelen:
    1.Vergelijken van de specificiteit, waar de gouden standaard consensus is met het expert panel waarbij alle relevante medische informatie voorhanden is inclusief 6 maanden klinische follow-up data.
    2. Analyse van de gevoeligheid per gebied: lokaal recidief, locoregionale lymfeklieren, lymfeklieren op afstand, botmetastasen, orgaanmetastasen.
    3. Kwantitatieve analyse: SUV metingen, tumor-achtergrond ratio's.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    - Males ≥ 18 years
    - Histologically proven adenocarcinoma of the prostate
    - Prior local treatment with curative intent
    - Biochemical recurrence with PSA-levels of 0.2-5.0 ug/L
    - PSA level determined <8 weeks before study participation
    Om deel te kunnen nemen, moeten alle proefpersonen voldoen aan onderstaande criteria:
    - Mannen, leeftijd ≥ 18 jaar
    - Histologisch bewezen adenocarcinoom van de prostaat
    - Eerdere lokale behandeling met curatieve opzet
    - Biochemisch recidief met PSA-waarden van 0,2-5,0 ug/l
    - PSA-waarde bepaald < 8 weken voor studiedeelname
    E.4Principal exclusion criteria
    A patient will be excluded from participation in the trial if one or more of the following criteria are met:
    - Contra-indications for PET-CT: claustrophobia or inability to lay still for the duration of the exam.
    - Other cancer < 2 years prior to biochemical recurrence
    Een patiënt zal worden geexcludeerd van deelname aan de studie als ze voldoen aan een of meerdere van onderstaande criteria:
    - Contra-indicatie voor PET-CT: claustrofobie of het onvermogen om stil te liggen gedurende de duur van het onderzoek
    - Andere oncologische aandoening < 2 jaar voorafgaand aan biochemisch recidief
    E.5 End points
    E.5.1Primary end point(s)
    Main study parameter: detection efficacy of the different PET-tracers. Both the number of patients in which disease activity is objected as well as the number of prostate cancer lesions that are detected will be compared. Goal is to show superiority of 18F-PSMA-1007 compared to 18F-Fluciclovine.
    Primaire uitkomstmaat: detectiegevoeligheid van de verschillende PET-tracers. Zowel het aantal patienten waarin ziekteactiviteit wordt geobjectiveerd alsmede het aantal prostaatkanker lesies dat gedetecteerd wordt, zal worden vergeleken. Doel is om superioriteit van 18F-PSMA-1007 aan te tonen ten opzichte van 18F-Fluciclovine.
    E.5.1.1Timepoint(s) of evaluation of this end point
    LVLS.
    Laatste visite van de laatste proefpersoon.
    E.5.2Secondary end point(s)
    Secondary parameters:
    1. Comparing specificity, where the golden standard is defined by an expert panel using data of both PET-CT’s and 6 months follow up data.
    2. Analysis of the sensitivity per area (local recurrence, locoregional lymph nodes, distant lymph nodes, bone metastases, other location)
    3. Quantitative analyses: SUV measurements, tumor-background ratio’s.
    Secundaire uitkomstmaten:
    1.Vergelijken van de specificiteit, waar de gouden standaard consensus is met het expert panel waarbij alle relevante medische informatie voorhanden is inclusief 6 maanden klinische follow-up data.
    2. Analyse van de gevoeligheid per gebied: lokaal recidief, locoregionale lymfeklieren, lymfeklieren op afstand, botmetastasen, orgaanmetastasen.
    3. Kwantitatieve analyse: SUV metingen, tumor-achtergrond ratio's.
    E.5.2.1Timepoint(s) of evaluation of this end point
    LVLS.
    Laatste visite van de laatste proefpersoon.
    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 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 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
    Superioriteit
    Superiority
    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 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.
    Laatste visite van de laatste proefpersoon.
    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 months0
    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: 15
    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 state50
    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)
    BSoC
    Standaard zorg
    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 Decision2018-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-01
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