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    Summary
    EudraCT Number:2022-003905-31
    Sponsor's Protocol Code Number:RF-2021-12372278
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-02-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2022-003905-31
    A.3Full title of the trial
    Fully hybrid 18F-PSMA PET/MRI as one-stop approach for the diagnosis of clinically
    significant prostate cancer
    Ruolo della metodica PET/MRI con 18F-PSMA come approccio di imaging integrato nella diagnosi di tumore prostatico clinicamente significativo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Role of the PET/resonance imaging method (which allows the acquisition of a PET and an MRI exam simultaneously) using the 18F-PSMA radiotracer (which binds to tumor cell proteins allowing their visualization) in the diagnosis of prostate cancer clinically significant
    Ruolo della metodica di imaging PET/risonanza (che permette l’acquisizione di un esame PET e uno di risonanza simultaneamente) utilizzando il radiotracciante 18F-PSMA (che si lega a proteine delle cellule tumorali permettendone la visualizzazione) nella diagnosi di tumore alla prostata clinicamente significativo
    A.3.2Name or abbreviated title of the trial where available
    PET/MRI with 18F-PSMA
    PET/MRI con 18F-PSMA
    A.4.1Sponsor's protocol code numberRF-2021-12372278
    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 SponsorOSPEDALE SAN RAFFAELE
    B.1.3.4CountryItaly
    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 supportMinistero della Salute (ricerca finalizzata)
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina, 60
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number0226436102
    B.5.6E-mailctc.trialstartup@hsr.it
    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 Yes
    D.2.1.1.1Trade name Radelumin
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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]PSMA-1007
    D.3.2Product code [18FPSMA-1007]
    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 INN[18F]PSMA-1007
    D.3.9.1CAS number 2043321-19-6
    D.3.9.2Current sponsor code[18F]PSMA-1007
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number455 to 2600
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 with clinical suspicion of clinically relevant prostate cancer
    Pazienti con sospetto clinico di tumore alla prostata clinicamente rilevante
    E.1.1.1Medical condition in easily understood language
    Patients with suspected prostate cancer
    Pazienti con sospetto tumore alla prostata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10026389
    E.1.2Term Malignant neoplasm of prostate
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the diagnostic accuracy of 18F-PSMA PET/MRI for the diagnosis of clinically relevant prostate cancer
    Determinare l’accuratezza diagnostica della PET/MRI con 18F-PSMA per la diagnosi di tumore alla prostata clinicamente rilevante
    E.2.2Secondary objectives of the trial
    1) Compare the proportion of patients with clinically relevant prostate cancer not identified by PET and MRI when examined separately
    2) To report the reduction of clinically irrelevant tumors by combining MRI and PET imaging and therefore the number of biopsies that could have been avoided.
    1) Comparare la proporzione di pazienti con tumore alla prostata clinicamente rilevante non identificati da PET e risonanza quando esaminate separatamente
    2) Riportare la riduzione di tumori clinicamente non rilevanti combinando la lettura di immagini risonanza e PET e quindi il numero di biopsie che si sarebbero potute evitare.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patients 18 years of age or older, identified as suspects for clinically significant prostate cancer
    2) Ability to undergo all protocol scrutiny
    3) Ability to provide informed consent
    1) Pazienti di almeno 18 anni, identificati come sospetti per tumore alla prostata clinicamente significativo
    2) Capacità di essere sottoposti a tutte le esaminazioni del protocollo
    3) Capacità di fornire consenso informato
    E.4Principal exclusion criteria
    1) Previous diagnosis of prostate cancer
    2) Contraindications to perform the MRI examination (e.g. claustrophobia, pacemaker, estimated GFR less than or equal to 50mls/min)
    3) Contraindications to perform the prostate biopsy
    1) Precedente diagnosi di tumore alla prostata
    2) Controindicazioni a svolgere l’esame di risonanza (es. claustrofobia, pacemaker, GFR stimato minore o uguale a 50mls/min)
    3) Controindicazioni a svolgere la biopsia prostatica
    E.5 End points
    E.5.1Primary end point(s)
    Diagnostic accuracy measured by sensitivity, specificity, and positive and negative predictive values
    Accuratezza diagnostica misurata tramite sensibilità, specificità, e valori predittivi positivo e negativo
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of enrollment, approximately 30 months.
    Al termine dell’arruolamento, approssimativamente a 30 mesi.
    E.5.2Secondary end point(s)
    1) The number of patients with clinically significant prostate cancer not identified by interpreting PET and MRI images individually;
    2) Considering only patients with positive MRI and negative PET: the proportion of patients with clinically insignificant prostate cancer; 1) Il numero di pazienti con tumore alla prostata clinicamente significativo non identificato interpretando le immagini PET e MRI singolarmente;
    2) Considerando solo i pazienti con risonanza positiva e PET negativa: la proporzione di pazienti con tumore alla prostata clinicamente non significativo
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of enrollment, approximately 30 months.
    Al termine dell’arruolamento, approssimativamente a 30 mesi.
    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) 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 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
    IN APERTO
    OPEN
    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.8.2.4Number 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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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 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: 83
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 state167
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 167
    F.4.2.2In the whole clinical trial 167
    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)
    At the end of the participation in the study, the patients will follow the normal therapeutic procedure foreseen by their pathology as per normal clinical practice.
    Al termine della partecipazione allo studio, i pazienti seguiranno il normale iter terapeutico previsto dalla loro patologia come da normale pratica clinica.
    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 Decision2023-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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