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    Summary
    EudraCT Number:2018-004310-18
    Sponsor's Protocol Code Number:SPL-01-001
    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:2020-07-14
    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 number2018-004310-18
    A.3Full title of the trial
    A confirmatory, prospective, open-label, single-arm, reader-blinded multi-centre phase 3 study to assess the diagnostic accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and unenhanced MRI in reference to histopathology in newly-diagnosed prostate cancer (PCA) patients, scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (ePLND)
    Een bevestigende, prospectieve, open label, éénarmige, lezer-geblindeerde, multicentrische fase 3 studie om de diagnostische nauwkeurigheid van Ferumoxtran-10-verbeterde magnetische resonantie beeldvorming (MRI) en onverbeterde MRI in verwijzing naar histopathologie te beoordelen in nieuw gediagnosticeerde patiënten met prostaatkanker (PCA), gepland voor een radicale prostatectomie (RP) met uitgebreide bekken lymfeklierdissectie (ePLND)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical phase 3 study to assess the accuracy of Ferumoxtran-10 in Magnetic Resonance Imaging (MRI) to detect cancerous tissue in patients which are scheduled for a radical prostatectomy (RP) with extended pelvic lymph node dissection (ePLND). All patients will receive the Ferumoxtran-10 and the imaging results will be compared with the analysis of the removed tissue samples.
    Een fase 3 klinische studie om de nauwkeurigheid te beoordelen van Ferumoxtran-10 in magnetische resonantie beeldvorming (MRI) om kankerweefsel op te sporen in patiënten die gepland zijn voor een radicale prostatectomie (RP) met uitgebreide bekken lymfeklierdissectie (ePLND). Alle patiënten zullen Ferumoxtran-10 toegediend krijgen en de resultaten van de beeldvorming zullen vergeleken worden met de analyse van de verwijderde weefselstalen.
    A.3.2Name or abbreviated title of the trial where available
    Prostaprogress
    A.4.1Sponsor's protocol code numberSPL-01-001
    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 SponsorSaving Patients' Lives Medical B.V.
    B.1.3.4CountryNetherlands
    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 supportSaving Patients' Lives Medical B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H.
    B.5.2Functional name of contact pointDr. Volker Meyer
    B.5.3 Address:
    B.5.3.1Street AddressBlasewitzer Strasse 78-80
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01307
    B.5.3.4CountryGermany
    B.5.4Telephone number00493512144417
    B.5.5Fax number00493512144415
    B.5.6E-mailvolker.meyer@abx-cro.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 nameFerumoxtran-10
    D.3.4Pharmaceutical form Powder for concentrate for solution for 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 INNFERUMOXTRAN-10
    D.3.9.1CAS number 189047-99-2
    D.3.9.2Current sponsor codeFerrotran®
    D.3.9.3Other descriptive nameFERUMOXTRAN-10
    D.3.9.4EV Substance CodeSUB31919
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number105.2
    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 No
    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
    newly-diagnosed prostate cancer (PCA)
    nieuw gediagnosticeerde prostaatkanker
    E.1.1.1Medical condition in easily understood language
    newly-diagnosed prostate cancer (PCA)
    nieuw gediagnosticeerde prostaatkanker
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    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
    1. To confirm superiority of Ferrotran®-enhanced MRI over unenhanced MRI in sensitivity to detect metastases in normal size pelvic lymph nodes in using histopathology after lymph node dissection as established reference method (Gold Standard).
    2. To confirm non-inferiority of Ferrotran®-enhanced MRI compared with unenhanced MRI in specificity with a margin of 15% in using histopathology after lymph node dissection as established reference method (Gold Standard).
    1. Bevestigen van superioriteit van Ferrotran-verbeterde MRI ten opzicht van onverbeterde MRI gevoeligheid om metastasen in bekken lymfeklieren van normale grootte te detecteren, gebruikmakend van histopathologie na lymfeklierdissectie als gevestigde referentiemethode (gouden standaard).
    2. Bevestigen van non-inferioriteit van Ferrotran-verbeterde MRI in vergelijking met onverbeterde MRI in specificiteit met een marge van 15% gebruikmakend van histopathologie na lymfeklierdissectie als gevestigde referentiemethode (gouden standaard).
    E.2.2Secondary objectives of the trial
    1. To confirm non-inferiority of Ferrotran®-enhanced MRI compared with unenhanced MRI in sensitivity with a margin of 15% to detect any pelvic lymph node metastases in using histopathology after lymph node dissection as established reference method (Gold Standard).
    2. To evaluate the number and sites (gross- and sub-regions) of affected lymph nodes removed and not removed by ePLND comparing the unenhanced MRI at follow-up and the pre-surgery MRIs (unenhanced and Ferrotran®-enhanced).
    3. To assess the clinical safety and tolerability of a single slow drip Ferrotran® infusion.
    4. To assess the impact of Ferrotran®-enhanced MRI on the patient management plan.
    1.Bevestigen van non-inferioriteit van Ferrotran-verbeterde MRI in vergelijking met onverbeterde MRI in gevoeligheid met een marge van 15% om bekken lymfeklier metastasen te zien, gebruikmakend van histopathologie na lymfeklierdissectie als gevestigde referentiemethode.
    2.Evalueren van het aantal en de plaatsen (bruto- en subregio's) van getroffen lymfeklieren verwijderd en niet verwijderd door ePLND bij vergelijking van de onverbeterde MRI tijdens de opvolging met de pre-chirurgische MRIs (onverbeterd en Ferrotran-verbeterd).
    3.Beoordelen van de klinische veiligheid en verdraagzaamheid van één langzame Ferrotran infusie.
    4.Beoordelen van de impact van de Ferrotran-verbeterde MRI op het patiëntbeheersplan.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Voluntarily given and written informed consent.
    2) Male ≥18 years of age.
    3) Histologically newly-confirmed adenocarcinoma of the prostate.
    4) Medium to high risk for lymph node metastasis, defined by either:
    a) PSA ≥ 10 ng/ml or
    b) Gleason-Score ≥ 7 or
    c) Stage cT2b or cT2c or T3 or T4
    5) Patients scheduled for radical prostatectomy (RP) with extended lymph node dissection (ePLND) between Day 7 and Day 42 after Ferrotran®-enhanced MRI.
    6) Consent to practice contraception until end of study, including female partners of childbearing potential. Effective contraceptive measures include hormonal oral, injected or implanted female contraceptives, male condom, vaginal diaphragm, cervical cap, intrauterine device.
    7) Preoperative PSA, clinical T-stage, primary Gleason grade, secondary Gleason grade.
    1) Vrijwillige en schriftelijke geïnformeerde toestemming.
    2) Mannelijk ≥18 jaar oud.
    3) Histologisch nieuw bevestigde adenocarcinoom van de prostaat.
    4) Gemiddeld tot hoog risico op lymfeklier metastasen, gedefinieerd door:
    a) PSA ≥ 10 ng/ml of
    b) Gleason-Score ≥ 7 of
    c) Stadium cT2b of cT2c of T3 of T4
    5) Patiënten gepland voor radicale prostatectomie (RP) met uitgebreide bekken lymfeklierdissectie (ePLND) tussen Dag 7 en Dag 42 na Ferrotran-versterkte MRI.
    6) Toestemmen om anticonceptie te gebruiken tot het einde van de studie, inclusief vruchtbare, vrouwelijke partners. Effectieve anticonceptie maatregelen zijn hormonaal oraal, geïnjecteerde of geïmplanteerde vrouwelijke anticonceptiva, mannelijke condoom, vaginaal diafragma, cervicale kap, spiraaltje.
    7) Pre-operatieve PSA, klinische T-stadium, primaire Gleason graad, secondaire Gleason graad.
    E.4Principal exclusion criteria
    1) Any contraindication to MRI, as per standard criteria.
    2) Any radiation therapy or systemic antiproliferative (chemo-, immuno, or hormonal) therapy for prostate cancer (Lupron, Taxotere, Casodex, Eulexin, Zoladex, etc.) prior to screening and until after post-surgery FUP MRI.
    3) Known hypersensitivity to Ferrotran®or its components such as dextran.
    4) Known hypersensitivity to other parenteral iron products.
    5) Acute allergy including drug allergies and allergic asthma.
    6) Evidence of iron overload or disturbances in the utilisation of iron (e.g., haemochromatosis, haemosiderosis, chronic haemolytic anaemia with frequent blood transfusions).
    7) Presence of liver dysfunction.
    8) Any other investigational medicinal product within 30 days prior to receiving study medication until end of study visit.
    9) Simultaneous participation in any other clinical trial.
    10) Abnormal safety laboratory values at screening or baseline that are assessed by the principal investigator as clinically relevant.
    11) Patients not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders), or other vulnerable patients (e.g. under arrest).
    1) Elke contra-indicatie voor MRI, as per standaard criteria.
    2) Elke bestralingstherapie of systemisch antiproliferatief (chemo-, immuno, of hormonaal) therapie voor prostaatkanker (Lupron, Taxotere, Casodex, Eulexin, Zoladex, etc.) voorafgaand aan de screening en tot na de post-operatieve opvolgings MRI.
    3) Gekende overgevoeligheid voor Ferrotran of zijn componenten zoals dextran.
    4) Gekende overgevoeligheid voor andere parenterale ijzerproducten.
    5) Acute allergie inclusief drugallergieën en allergische astma.
    6) Bewijs van ijzeropstapeling of verstoring in het gebruik van ijzer (bijv. hemochromatose, hemosiderosis, chronische hemolytische anemie met frequente bloedtransfusies).
    7) Aanwezigheid van leverdisfunctie.
    8) Elke ander geneesmiddel voor onderzoek binnen 30 dagen voor toediening van de studiemedicatie tot het einde van de studie.
    9) Simultane deelname aan elke andere klinische studie.
    10) Abnormale veiligheidslaboratoriumwaarden tijdens screening of baseline die door de hoofdonderzoeker als klinisch relevant beschouwd worden.
    11) Patiënten niet in staat om zelfstandig betekenisvolle geïnformeerde toestemming te verklaren (bijv. met wettelijke voogd voor mentale stoornis), of andere kwetsbare patiënten (bijv. gedetineerden).
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary endpoints for this study will be the observed sensitivity and observed specificity of the Ferrotran-enhanced MRI compared with the unenhanced baseline MRI, in assessing the nodal status (metastatic / non-metastatic) of the patient with respect to the lymph nodes considered for lymphadenectomy.
    Specificity and sensitivity of Ferrotran-enhanced and un-enhanced MRI will be obtained by comparison of each method to histopathology results, and not by direct comparison of the MRI methods with each other.
    The patient will be considered metastatic (patientpositive) if at least one lymph node is diagnosed as metastatic in histopathology.
    De co-primaire eindpunten voor deze studie zullen de geobserveerde gevoeligheid en geobserveerde specificiteit van de Ferrotran verbeterde MRI in vergelijking met de onverbeterde baseline MRI zijn, bij de beoordeling van de nodale status (gemetastaseerd / niet-gemetastaseerd) van de patiënt met betrekking tot de lymfeklieren die in aanmerking komen voor lymfadenectomie.
    Specificiteit en gevoeligheid van Ferrotran verbeterde en onverbeterde MRI zal bekomen worden door vergelijking van elke methode met de histopathologische resultaten, en niet door directe vergelijking van de MRI methodes met elkaar.
    De patiënt zal als metastatisch (patiënt positief) beschouwd worden als tenminste 1 lymfeklier metastatisch is volgens de histopathologie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study visit
    Einde van de studie visite
    E.5.2Secondary end point(s)
    Secondary endpoints:
    Secondary efficacy endpoints:
    a) The number and regions of lymph node metastases present in the follow-up MRI in comparison to pre-surgery MRI (unenhanced and Ferrotran®-enhanced).
    b) Patients with additional dissection of lymph nodes outside the defined 8 pelvic regions due to Ferrotran® uptake i.e. pre-sacral, peri-rectal, para-aortic, which are not the standard of ePLND.
    The secondary efficacy endpoints will be assessed on the basis of the secondary efficacy variables as described below.

    Endpoint for patient management
    Impact of Ferrotran®-enhanced MRI on patient management

    Endpoints for safety and tolerability
    Frequency of occurrence and severity of abnormal findings in safety investigations (physical examination, vital signs, 12 lead ECG, clinical laboratory, AEs, concomitant medication) after a single slow drip Ferrotran® infusion.
    The assessment of safety and tolerability endpoints will be based on secondary safety and tolerability variables as described below.

    Exploratory endpoints:
    Qualitative assessment of
    • Vessel visibility
    • Image quality
    Secundaire eindpunten:
    Secundaire werkzaamheidseindpunten:
    a) Het aantal en de regio's van lymfkliermetastasen aanwezig in de follow-up MRI in vergelijking met pre-chirurgische MRI (niet versterkt en Ferrotran®-versterkt).
    b) Patiënten met extra dissectie van lymfeklieren buiten de gedefinieerde 8 bekkenregio's als gevolg van de opname van Ferrotran®, d.w.z. pre-sacrale, peri-rectale, para-aorta, die niet de standaard zijn van ePLND.
    De secundaire werkzaamheidseindpunten worden beoordeeld op basis van de secundaire werkzaamheidsvariabelen zoals hieronder beschreven.

    Eindpunt voor patiëntenbeheer
    Impact van door Ferrotran® verbeterde MRI op patiëntbeheer

    Eindpunten voor veiligheid en verdraagzaamheid
    Frequentie van voorkomen en ernst van abnormale bevindingen bij veiligheidsonderzoeken (lichamelijk onderzoek, vitale functies, 12-lead ECG, klinisch laboratorium, AE's, gelijktijdige medicatie) na een enkele langzame infusie met Ferrotran®.
    De beoordeling van eindpunten voor veiligheid en verdraagbaarheid zal worden gebaseerd op secundaire veiligheids- en verdraagbaarheidsvariabelen zoals hieronder beschreven.

    Verkennende eindpunten:
    Kwalitatieve beoordeling van:
    • zichtbaarheid van vaten
    • beeldkwaliteit
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy endpoints: Day 1 & surgery
    Endpoint for patient management: Day 1 until surgery
    Endpoints for safety and tolerability: Day 1 until Day 7, Safety Follow Up & End of Study
    Exploratory endpoints: Day 1
    Secundaire eindpunten voor werkzaamheid: Dag 1 & operatie
    Eindpunt voor patiëntenbeheer: Dag 1 tot operatie
    Eindpunten voor veiligheid en verdraagzaamheid: Dag 1 tot Dag 7, Veiligheidsopvolging & einde van de studie
    Verkennende eindpunten: Dag 1
    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 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
    éénarmig, lezer geblindeerd
    single-arm, reader-blinded
    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 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 EEA8
    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
    Switzerland
    Germany
    Netherlands
    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
    The end of the trial is defined as the last visit of the last patient or the
    last date of follow-up of toxicities, if required (whichever is the later).
    Het einde van de studie is gedefinieerd als de laatste visite van de laatste patiënt of de laatste datum van opvolging van toxiciteiten, indien nodig (welke de laatste is).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 200
    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 Decision2020-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
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