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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-001034-18
    Sponsor's Protocol Code Number:PETMR-Staging-PCa1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-11-05
    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 number2018-001034-18
    A.3Full title of the trial
    Phase II monocentric study to evaluate a novel approach for staging prostate cancer patients by using a fully integrated hybrid PET/MRI
    Studio monocentrico di Fase II per valutare un approccio innovativo per la stadiazione del paziente con carcinoma prostatico con l’utilizzo della tecnica ibrida PET/RM
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on patients with prostate cancer with the PET/MR
    Studio su pazienti con tumore alla prostata con la metodica PET/RM
    A.3.2Name or abbreviated title of the trial where available
    PETMR-Staging-PCa1
    PETMR-Staging-PCa1
    A.4.1Sponsor's protocol code numberPETMR-Staging-PCa1
    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 supportAIRC
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportMinistero della Salute
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Ospedale San Raffaele
    B.5.2Functional name of contact pointMedicina Nucleare
    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 number0226437053
    B.5.5Fax number0226432717
    B.5.6E-mailincerti.elena@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 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 name68GA-PSMA-HBED-CC
    D.3.2Product code [68GA-PSMA-HBED-CC]
    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 INNPSMA-HBED-CC (PSMA-11)
    D.3.9.2Current sponsor code68Ga-PSMA
    D.3.9.3Other descriptive name68Ga-PSMA
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number110 to 210
    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.IMP: 2
    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 name68GA-DOTA-RM2
    D.3.2Product code [68GA-DOTA-RM2]
    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 INNDOTA-RM2 ACETATO
    D.3.9.2Current sponsor codeDOTA-RM2 ACETATO
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number90 to 190
    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
    Patient diagnosed with prostatic carcinoma
    Paziente con diagnosi di carcinoma prostatico
    E.1.1.1Medical condition in easily understood language
    Patient with prostate cancer
    Paziente con carcinoma della 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
    Evaluate a new diagnostic and innovative approach for the staging of prostate cancer with the use of the recently introduced PET/MR imaging method and new tracers (68Ga-PSMA and 68Ga-Bombesina).
    Valutare un nuovo approccio diagnostico ed innovativo per la stadiazione del tumore prostatico con l’utilizzo della metodica di imaging di recente introduzione PET/RM e nuovi traccianti (68Ga-PSMA e 68Ga-Bombesina).
    E.2.2Secondary objectives of the trial
    - Optimize the image acquisition and analysis protocol of the innovative PET/MR methodology in order to offer an optimal approach.
    - Characterize the phenotype of the prostatic primary tumor using: 1) hybrid PET/MR imaging with 68Ga-PSMA and 68Ga-Bombesin tracers, 2) multiparametric MRI (mp-MR) techniques; and 3) integrated radiomal analysis with clinical, histopathological and cellular markers of tumor aggression based on peripheral blood particle counts and biochemical, clinical and instrumental follow-up.
    - Evaluate the stability / reproducibility of the radiomic analysis on mp-MR data for the characterization of the tumor by a testretest procedure.
    - Define the diagnostic accuracy of PET/MR with 68Ga-PSMA and 68Ga-Bombesina and with state-of-the-art mp-MR staging techniques (T, N and M).
    - Evaluate the impact of PET/MR with 68Ga-PSMA and 68Ga-Bombesina in the choice of therapeutic strategies and clinical management of the patient.
    - Ottimizzare il protocollo di acquisizione e di analisi delle immagini della metodica innovativa PET/RM al fine di offrire un approccio ottimale.
    - Caratterizzare il fenotipo del tumore primitivo prostatico utilizzando: 1) imaging ibrido PET/RM con i traccianti 68Ga-PSMA e 68Ga-Bombesina, 2) tecniche di RM multiparametrica (mp-RM); e 3) analisi radiomica integrata con marcatori clinici, istopatologici e cellulari di aggressività tumorale basati sulla conta di particelle nel sangue periferico e sul follow-up biochimico, clinico e strumentale.
    - Valutare la stabilità/riproducibilità dell’analisi radiomica sui dati mp-RM per la caratterizzazione del tumore mediante procedura test-retest.
    - Definire l’accuratezza diagnostica della PET/RM con 68Ga-PSMA e 68Ga-Bombesina e con le tecniche mp-RM allo stato dell’arte nella stadiazione (T, N e M).
    - Valutare l’impatto della PET/RM con 68Ga-PSMA e 68Ga-Bombesina nella scelta delle strategie terapeutiche e gestione clinica del paziente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age = 18 years
    2. Diagnosis of prostate cancer proven by biopsy
    3. Informed informed consent
    1. Età = 18 anni
    2. Diagnosi di tumore alla prostata comprovata dalla biopsia
    3. Consenso informato firmato
    E.4Principal exclusion criteria
    1. Age less than 18 years
    2. Inability to complete required imaging tests (eg severe claustrophobia)
    3. Any other medical condition that may interfere with study compliance
    4. All contraindications for MRI (eg pace-maker)
    5. Evidence of metastatic disease to conventional imaging that would contraindicate the surgical procedure
    1. Età inferiore a 18 anni
    2. Incapacità di completare gli esami di imaging richiesti (es. severa claustrofobia)
    3. Qualunque altra condizione medica che possa interferire con la compliance dello studio
    4. Tutte le controindicazioni per RM (es. pace-maker)
    5. Evidenza di malattia metastatica all’imaging convenzionale che controindicherebbe la procedura chirurgica
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the staging of patients with prostate cancer using PET / MR hybrid imaging with innovative radiopharmaceuticals (68Ga-PSMA and 68Ga-Bombesina) and
    tumor biomarkers.
    Valutazione della stadiazione dei pazienti con tumore prostatico mediante imaging ibrido PET/RM con radiofarmaci innovativi (68Ga-PSMA e 68Ga-Bombesina) e biomarcatori tumorali.
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 months
    60 mesi
    E.5.2Secondary end point(s)
    - Optimization of the PET/MR acquisition protocol with 68Ga-PSMA and 68Ga-Bombesina for the staging of the patient with prostate tumor.; Characterization of the tumor phenotype with imaging and histopathological data.; - Definition of the stability/reproducibility of the radiomic analysis.; - Evaluation of the diagnostic accuracy of PET/MR with 68Ga-PSMA and 68Ga-Bombesina.
    - Ottimizzazione del protocollo di acquisizione PET/RM con 68Ga-PSMA e 68Ga-Bombesina per la stadiazione del paziente con tumore prostatico.; - Caratterizzazione del fenotipo tumorale con i dati di imaging ed istopatologici.; - Definizione della stabilità/riproducibilità dell’analisi radiomica.; - Valutazione dell’accuratezza diagnostica della PET/RM con 68Ga-PSMA e 68Ga-Bombesina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 months; 60 months; 60 months; 60 months
    60 mesi; 60 mesi; 60 mesi; 60 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 years5
    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 years5
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 50
    F.4.2.2In the whole clinical trial 50
    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 CLINICAL EXPERIMENTATION (execution of PET/MR study with 68Ga-PSMA and 68Ga-Bombesina) PATIENTS WILL CONTINUE THE CLINICAL ITER INTENDED FOR THEIR PATHOLOGY.
    AL TERMINE DELLA SPERIMENTAZIONE CLINICA (esecuzione studio PET/RM con 68Ga-PSMA e 68Ga-Bombesina) I PAZIENTI PROSEGUIRANNO L’ITER CLINICO PREVISTO PER LA LORO PATOLOGIA.
    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 Decision2020-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-04
    P. End of Trial
    P.End of Trial StatusOngoing
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