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    Summary
    EudraCT Number:2020-001219-26
    Sponsor's Protocol Code Number:N20PIP
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-02
    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 number2020-001219-26
    A.3Full title of the trial
    Prostatic Artery Injection vs Intra-Venous Injection of 18F-DCFPyL to evaluate treatment strategy in Prostate Cancer
    Toediening via de prostaatslagaders vs intra-veneuze toediening van f 18F-DCFPyL voor de evaluatie van een nieuwe behandelstrategie voor prostaatkanker
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PET/CT scan after injection of a radio-active tracer in the prostatic artery in prostate cancer
    PET/CT scan na toediening van radioactieve marker in de prostaatslagaders bij prostaatkanker
    A.3.2Name or abbreviated title of the trial where available
    PAI vs IV injection of 18F-DCFPyL PET/CT in Prostate Cancer
    PAI vs IV toediening van 18F-DCFPyL PET/CT bij prostaatkanker
    A.4.1Sponsor's protocol code numberN20PIP
    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 Sponsortichting Het Nederlands Kanker Instituut_Antoni van Leeuwenhoek
    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 supporttichting Het Nederlands Kanker Instituut_Antoni van Leeuwenhoek
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationtichting Het Nederlands Kanker Instituut_Antoni van Leeuwenhoek
    B.5.2Functional name of contact pointDr H. van der Poel
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityamsterdam
    B.5.3.3Post code1066CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205122556
    B.5.5Fax number0031205122572
    B.5.6E-mailh.vd.poel@nki.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]DCFPyL PSMA
    D.3.2Product code [18F]DCFPyL PSMA
    D.3.4Pharmaceutical form Solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN[18F]DCFPyL
    D.3.9.2Current sponsor code[18F]DCFPyL
    D.3.9.3Other descriptive nameF-18-PSMA-1007
    D.3.9.4EV Substance CodeSUB194628
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number37
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Prostaat kanker
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    Prostaat kanker
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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
    To evaluate the ability to concentrate the radiotracer in the target tissue by prostatic artery injection (PAI), especially within the prostate gland compared to standard systemic intra-venous (IV) administration.
    Primaire doelstelling van deze studie is het evalueren van de mogelijkheid om de radiotracer 18F-DCFPyL PSMA te concentreren in de prostaat bij patiënten met prostaatkanker na intra-arteriële toediening in de prostaatslagaders van de tracer vergeleken met intra-veneuze toediening volgens de richtlijnen.
    E.2.2Secondary objectives of the trial
    • To evaluate the PET/CT targeting characteristics of prostatic artery injection (PAI) with 18F-DCFPyL to non-target tissue; especially to the kidneys and salivary glands in comparison with IV administration .
    • Correlation of 18F-DCFPyL uptake in prostatic lesions and lymph node after IV and PAI injections with standard multi-parametric MRI
    Study
    Secundaire doelstelling is het evalueren van de opname van 18F-DCFPyL PSMA na intra-arteriële toediening door andere weefsels (non-target tissue), zoals de nieren en speekselklieren, in vergelijking tot de opname na intra-veneuze toediening.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age >18 years
    • Confirmed histological diagnosis of PCa
    • The Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
    • Received a baseline multi-parametric MRI and 18F-DCFPyL PET scan ≤ 6 month prior to inclusion in our study done in NKI-AVL
    • Demonstrate adequate hematologic and organ function, defined by the following laboratory results.
    • Signed Informed Consent Form
    • All (T) (N) (M) Stages
    • Ouder dan 18 jaar
    • Bevestigde prostaatkanker
    • The Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
    • Baseline multi-parametric MRI and 18F-DCFPyL PET scan ≤ 6 maanden voor inclusie gedaan in NKI-AVL
    • Adequate orgaan functie en hematologische waarden
    • Getekend informed consent
    • Alle T, N, M stadia
    E.4Principal exclusion criteria
    • History of concomitant malignancies
    • Severe allergy for iodine-based contrast agents
    • Prior treatments with brachytherapy or prostatectomy
    • Inability to undergo intra-arterial procedure secondary to vascular abnormalities
    • Body weight over 150 kg
    • Severe allergy for I.V. contrast used in angiography
    • Kanker in de voorgeschiedenis
    • Ernstige allergie voor iodine bevattende contrast middelen
    • Eerder behandeld met brachy therapie of prostaatresectie
    • Lichaamsgewicht >150kg
    • Vasculaire aandoeningen die intra-arteriele toediening verhinderen
    • Ernstige allergie voor contrastmiddel dat gebruikt wordt tijdens de angiografie
    E.5 End points
    E.5.1Primary end point(s)
    • Increase of the amount of tracer in the target tissue by 30% compared to systemic administration evaluated measured on PET/CT images SUV(mean and/ or max) ) compared to systemic PET.
    Een 30% verhoogde concentratie van de tracer in de prostaat op de PETC CT scan na intra-arteriële toediening van 18F-DFCPyL PSMA in de prostaatslagaders in vergelijking tot de concentratie van de tracer in de prostaat op de PET CT scan na intra-veneuze toediening.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the PET scan with intra-arterial administration of [18F] DCFPyL
    na de PET scan waarvoor [18F] DCFPyL intra arteriaal is toegediend
    E.5.2Secondary end point(s)
    • Lower the amount of tracer in the non-target tissue, especially to the kidneys and salivary glands, by 30% compared to systemic administration evaluated via the radiation measured on PET/CT images SUV(mean and/ or max) compared to systemic PET.
    • Detection of new lesions in the primary prostate tumor within the prostate gland or local lymph node identification / micro metastasis after local administration compared to standard of care systemic administration.
    Daarnaast een 30% verlaging van concentratie van de tracer in andere organen op de PET CT scan na PIA van 18F-DFCPyL in vergelijking tot na IA toediening
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the PET scan with intra-arterial administration of [18F] DCFPyL
    na de PET scan waarvoor [18F] DCFPyL intra arteriaal is toegediend
    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 Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    intra-veneuze toediening van [18F] DCFPyL
    intra-venous administration of [18F] DCFPyL
    E.8.2.4Number of treatment arms in the trial1
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    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: 21
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 state21
    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)
    Patients will be referred for prostate surgery or another treatment for prostate cancer
    Patienten worden doorverwezen voor prostaat operatie of andere behandeling voor prostaatkanker
    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 Decision2021-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-29
    P. End of Trial
    P.End of Trial StatusOngoing
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