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    Summary
    EudraCT Number:2020-005042-42
    Sponsor's Protocol Code Number:IASONFC303
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-11
    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 ConcernedAustria - BASG
    A.2EudraCT number2020-005042-42
    A.3Full title of the trial
    Prospective study of added value of florastamin (18F) PET/CT in localisation of clinically significant prostate cancer in patients with PI-RADS≤3 report of multi-parametric MRI, elevated serum PSA levels and/or PSA density and with clinical suspicion of prostate cancer
    Prospektive Studie zum Mehrwert eines Florastamin (18F) PET / CT bei der
    Lokalisation von klinisch signifikantem Prostatakrebs bei Patienten mit PIRADS ≤
    3 Befund eines multiparametrischen MRT, erhöhtem Serum-PSA-Spiegel und / oder
    PSA-Dichte und mit klinischem Verdacht auf Prostatakrebs.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective study of added value of florastamin (18F) PET/CT in localisation of clinically significant prostate cancer in patients with negative or equivocal result of multi-parametric MRI, elevated serum PSA levels and/or PSA density and with clinical suspicion of prostate cancer
    Prospektive Studie zum Mehrwert eines Florastamin (18F) PET / CT bei der
    Lokalisation von klinisch signifikantem Prostatakrebs bei Patienten mit
    negativem oder nicht eindeutigem Ergebnis bei einem multiparametrischen MRT, erhöhtem Serum-PSA Spiegel und / oder PSA-Dichte und mit klinischem Verdacht auf Prostatakrebs.
    A.3.2Name or abbreviated title of the trial where available
    Florastamin (18F) PET/CT vs. mpMRI in localisation of clinically significant prostate cancer
    Florastamin (18F) PET / CT vs. mpMRI bei Lokalisation von klinisch signifikantem
    A.4.1Sponsor's protocol code numberIASONFC303
    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 SponsorIASON GmbH
    B.1.3.4CountryAustria
    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 supportIASON GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIASON GmbH
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressFeldkirchner Strasse 4
    B.5.3.2Town/ citySeiersberg
    B.5.3.3Post code8054
    B.5.3.4CountryAustria
    B.5.4Telephone number00436645315021
    B.5.5Fax number00433162843007
    B.5.6E-mailclinical.trials@iason.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 nameFlorastamin (18F)
    D.3.2Product code FC303
    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 INNFlorastamin (18F)
    D.3.9.2Current sponsor codeFC303
    D.3.9.3Other descriptive name(9S,13S)-1-(1-(2-(2-(2-[18F]fluoroethoxy)ethoxy)ethyl)-1H-1,2,3-triazol-4-yl)-3,11-dioxo-2,4,10,12-tetraazapentadecane-9,13,15-tricarboxylicacid
    D.3.9.4EV Substance CodeSUB221317
    D.3.10 Strength
    D.3.10.1Concentration unit GBq/ml gigabecquerel/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.7
    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 suspected clinically and on the basis of elevated serum Prostate Specific Antigen (PSA) levels and/or PSA density and with result of multiparametric Magnetic Resonance Imaging (mpMRI) of prostate gland scored ≤3 according to PI-RADS v2.1
    Prostatakrebs der klinisch und aufgrund eines erhöhten Serums vermutet wird
    Prostata-spezifische Antigen (PSA) -Niveaus und / oder PSA-Dichte und mit Ergebnis einer
    multiparametrischen Magnetresonanztomographie (mpMRI) der Prostatadrüse erzielte ≤3 gemäß PI-RADS v2.1
    E.1.1.1Medical condition in easily understood language
    Prostate cancer suspected clinically and on the basis of elevated serum PSA levels and/or PSA density and with negative or equivocal result of Magnetic Resonance Imaging (MRI) of prostate gland
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10053838
    E.1.2Term Free prostate-specific antigen increased
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10050321
    E.1.2Term Prostate examination
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029096
    E.1.2Term Neoplasm prostate
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10004385
    E.1.2Term Benign neoplasm of prostate
    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 analyse the patient-based sensitivity of florastamin (18F) PET/CT for localisation of csPCa in patients with elevated serum PSA levels and/or PSA density and with clinical suspicion of PCa and with report of mpMRI of prostate gland scored ≤3 according to PI-RADS v2.1
    • Analyse der patientenbasierten Empfindsamkeit von Florastamin (18F) PET / CT für die Lokalisierung von csPCa bei Patienten mit erhöhten Serum-PSA-Spiegeln und / oder PSA-Dichte und mit klinischem Verdacht auf PCa und mit einem Befund eines mpMRI der Prostata, der mit ≤3 bewertet wurde gemäß PI-RADS v2.1
    E.2.2Secondary objectives of the trial
    • To confirm the tolerability of florastamin (18F)
    • To assess the patient anf the site-based specificity and positive and negative predictive value and site-based sensitivity of florastamin (18F) PET/CT for localisation of csPCa
    • To assess the net reclassification index of florastamin (18F) for localisation of csPCa
    • To assess the frequency of impact of florastamin (18F) PET/CT on diagnostic thinking
    • To assess the frequency of impact of florastamin (18F) PET/CT on patient management.
    • To correlate:
    - the patient based diagnostic performance of florastamin (18F) PET/CT in detection of csPCa with prostate health index when available
    - the quantitative uptake of florastamin (18F) with diagnostic performances in localization of csPCa.
    - quantitative uptake of florastamin (18F) with histopathological results
    • To refine the interpretation criteria of florastamin (18F) PET/CT
    • Bestätigung der Verträglichkeit von Florastamin (18F)
    • Beurteilung des Patienten und der ortsbezogenen Spezifität sowie der positiven und negativen Vorhersagewerte und ortsbezogenen Empfindlichkeit eines Florastamin (18F) PET/CT zur Lokalisierung von csPCa
    • Bewertung des Netto-Reklassifizierungsindex von Florastamin (18F) zur Lokalisierung von csPCa
    • Um die Häufigkeit eines Einflusses eines Florastamin (18F) PET/CT auf diagnostisches Denken zu bewerten
    • Um die Häufigkeit eines Einflusses eines Florastamin (18F) PET/CT auf das Patienten Management zu bewerten.
    • Korrelation der:
    -patientenbasierten diagnostischen Leistung eines Florastamin (18F) PET/CTs zum Nachweis von csPCa mit Prostata Health Index wenn verfügbar
    -quantitativen Aufnahme von Florastamin (18F) mit Diagnoseleistungen bei der Lokalisierung von csPCa.
    -quantitativen Aufnahme von Florastamin (18F) mit histopathologischen Ergebnissen
    • Verfeinerung der Interpretationskriterien für Florastamin (18F) PET/CT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male gender;
    • Age ≥18 years;
    • PSA ≥10ng/mL and/or PSAD≥0.26 ng/mL2;
    • PI-RADS v2 ≤3 report of mpMRI performed less than 3 months prior inclusion;
    • Availability of mpMRI data for centralized reading;
    • Patient scheduled for biopsy or radical prostatectomy;
    • Signed informed consent;
    • Absence of any of the exclusion criteria.
    Männliches Geschlecht;
    • Alter ≥ 18 Jahre;
    • PSA ≥ 10 ng / ml und / oder PSAD ≥ 0,26 ng / ml 2;
    • PI-RADS v2 ≤3-Befund eines mpMRI, das weniger als 3 Monate vor der Aufnahme durchgeführt wurde;
    • Verfügbarkeit von mpMRI-Daten zum zentralen Lesen;
    • Patient, der für eine Biopsie oder radikale Prostatektomie vorgesehen ist;
    • Unterzeichnete Einverständniserklärung;
    • Fehlen eines der Ausschlusskriterien.
    E.4Principal exclusion criteria
    • Absence of any of the inclusion criteria;
    • Hypersensitivity to active substance or any of excipients of investigational medicinal product
    • Life expectancy <6 months;
    • ECOG performance status >2.
    • Concomitant active malignancy and/or confirmed metastases
    • Past history of confirmed prostate cancer.
    • Fehlen eines der Einschlusskriterien;
    • Überempfindlichkeit gegen Wirkstoff oder einen der sonstigen Bestandteile des Prüfpräparats
    • Lebenserwartung <6 Monate;
    • ECOG-Leistungsstatus> 2.
    • Begleitende aktive Malignität und / oder bestätigte Metastasen
    • Vorgeschichte von bestätigtem Prostatakrebs.
    E.5 End points
    E.5.1Primary end point(s)
    Localisation of csPCa by florastamin (18F) PET/CT in patients with elevated serum PSA levels and/or PSA density and with clinical suspicion of PCa and with report of mpMRI of prostate gland scored ≤3 according to PI-RADS v2., scheduled for prostate biopsy or for radical prostatectomy.
    Lokalisierung von csPCa durch ein Florastamin (18F) PET / CT bei Patienten mit erhöhten PSA-Spiegeln im Serum und / oder PSA-Dichte und mit klinischem Verdacht auf PCa, und mit einem Befund eines mpMRI der Prostatadrüse ≤3 gemäß PI-RADS, der für eine Prostata-Biopsie oder für eine radikale Prostatektomie vorgesehen ist.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated on the basis of standard of truth during six month follow-up period in each included subject.
    For whole study, the primary endpoint will be assessed six months after inclusion of the last evaluable patient.
    Der primäre Endpunkt wird während der sechsmonatigen Nachbeobachtungszeit für jeden Teilnehmer der Studie auf Grundlage des Wahrheitsstandards bewertet.
    Für die gesamte Studie wird der primäre Endpunkt sechs Monate nach Einbeziehung des letzten untersuchbaren Patienten bestimmt.
    E.5.2Secondary end point(s)
    • Adverse reaction(s) related with use of florastamin (18F)
    • Adverse event(s) related with use of florastamin (18F)
    • Impact of florastamin (18F) PET/CT on diagnostic thinking
    • Impact of florastamin (18F) PET/CT on patient management
    • Nebenwirkungen im Zusammenhang mit der Verwendung von Florastamin (18F)
    • Unerwünschte Ereignisse im Zusammenhang mit der Verwendung von Florastamin (18F)
    • Einfluss eines Florastamin (18F) PET / CTs auf das diagnostische Denken
    • Einfluss eines Florastamin (18F) PET / CTs auf das Patientenmanagement
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Adverse reaction(s) related with use of florastamin (18F)
    • Adverse event(s) related with use of florastamin (18F)
    • Impact of florastamin (18F) PET/CT on diagnostic thinking
    • Impact of florastamin (18F) PET/CT on patient management
    • Incidental finding(s) of florastamin (18F) PET/CT
    • Abnormality of biodistribution of florastamin (18F)
    • Nebenwirkungen im Zusammenhang mit der Verwendung von Florastamin (18F)
    • Unerwünschte Ereignisse im Zusammenhang mit der Verwendung von Florastamin (18F)
    • Einfluss eines Florastamin (18F) PET / CTs auf das diagnostische Denken
    • Einfluss eines Florastamin (18F) PET / CTs auf das Patientenmanagement
    • Zufällige Befunde eines Florastamin (18F) PET / CTs
    • Abnormalität der Bioverteilung von Florastamin (18F)
    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 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) 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 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 Yes
    E.8.1.7.1Other trial design description
    Prospective comparative trial with diagnostic product with blind reading and with standard of truth
    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
    multiparametric Magnetic Resonance Imaging (mpMRI)
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Completion of standard of truth and six-month clinical follow-up period in last included and evaluable patient.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 71
    F.4.2.2In the whole clinical trial 71
    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)
    Not applicable
    Unzutreffend
    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 Decision2021-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-29
    P. End of Trial
    P.End of Trial StatusOngoing
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