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    Summary
    EudraCT Number:2017-002651-28
    Sponsor's Protocol Code Number:IRST185.05
    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:2018-10-19
    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 number2017-002651-28
    A.3Full title of the trial
    Multi-cohort investigational study to evaluate the impact of pelvic mp-3TMRI and whole-body 68Ga-PSMA PET/CT for diagnosis of clinically-significant prostate cancer and pre-surgical staging.
    Studio diagnostico multi-coorte per valutare l'impatto della mp-3TMRI pelvica e della 68Ga-PSMA PET/CT whole body nella diagnosi e nello staging pre-chirurgico del carcinoma prostatico clinicamente significativo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multi-cohort investigational study to evaluate the impact of pelvic mp-3TMRI and whole-body 68Ga-PSMA PET/CT for diagnosis of clinically-significant prostate cancer and pre-surgical staging.
    Studio diagnostico multi-coorte per valutare l'impatto della mp-3TMRI pelvica e della 68Ga-PSMA PET/CT whole body nella diagnosi e nello staging pre-chirurgico del carcinoma prostatico clinicamente significativo
    A.3.2Name or abbreviated title of the trial where available
    BIOPSTAGE
    BIOPSTAGE
    A.4.1Sponsor's protocol code numberIRST185.05
    A.5.4Other Identifiers
    Name:NDNumber:NA
    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 SponsorISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
    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 supportIRST IRCCS
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRST IRCCS
    B.5.2Functional name of contact pointCentro di Coordinamento Studi IRST
    B.5.3 Address:
    B.5.3.1Street AddressDipartimento di Oncologia ed Ematologia, Ospedale Civile S. Maria delle Croci, viale Randi, 5
    B.5.3.2Town/ cityRavenna
    B.5.3.3Post code48121
    B.5.3.4CountryItaly
    B.5.4Telephone number0544285813
    B.5.5Fax number0544285330
    B.5.6E-mailcc.ubsc@irst.emr.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-HBED-CC-PSMA_IRSTIRCCS
    D.3.2Product code 68Ga-HBED-CC-PSMA_IRSTIRCCS
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN68Ga-HBED-CC-PSMA_IRSTIRCCS
    D.3.9.2Current sponsor code68Ga-HBED-CC-PSMA_IRSTIRCCS
    D.3.9.4EV Substance CodeSUB178157
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 200
    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 Yes
    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
    carcinoma della prostata
    E.1.1.1Medical condition in easily understood language
    prostate cancer
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001186
    E.1.2Term Adenocarcinoma 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
    COHORTS 1 and 2: TO ASSESS THE SEPARATE DIAGNOSTIC ACCURACY OF 68GA-PSMA PET/CT AND MP-3TMRI FOR IMAGING-GUIDED DIAGNOSIS / EXCLUSION OF CLINICALLY-SIGNIFICANT PCA. COHORT 3a: To characterize the detection rate and intra-prostatic localization of primary CS-PC foci by separate pelvic mp-3TMRI, whole-body 68Ga-PSMAHBED PET/CT and comparing to pathology outcomes in men with biopsy-proven PCa. COHORT 3b: to characterize the staging accuracy of pelvic mp-3TMRI in the pre-surgical work-up of PCa patients who are candidates for nerve-sparing surgery (NSS)
    COORTI 1 e 2: valutare l'accuratezza diagnostica separata delle due metodiche di imaging 68Ga-PSMA PET/CT e mp-3TMRI, per la diagnosi/esclusione imaging-guided di PCa clinicamente significativo. COORTE 3a: caratterizzare il tasso di rilevazione e localizzazione intra-prostatica dei foci primari di CS-PCa delle due metodiche di imaging 68Ga-PSMA PET/CT e mp-3TMRI separatamente, e confrontare l’outcome della malattia negli uomini con biopsie positive per PCa. COORTE 3b: caratterizzare l'accuratezza di stadiazione dell’mp-3TMRI pelvico nel work-up pre-chirurgico dei pazienti con PCa candidati alla chirurgia nerve-sparing (NSS).
    E.2.2Secondary objectives of the trial
    COHORTS 1 and 2: Safety / Toxicity of BIOPSTAGE interventional imaging procedures, namely 68Ga-PSMA ad-ministration (the PET tracer) and Gadoteric Acid (the MRI contrast agent) and of BIOPSTAGE TRUS-guided prostate biopsies sessions. COHORT 3a: - To determine separate diagnostic accuracy of 68Ga-PSMA PET/CT and mp-3TMRI for detecting and localizing N1 disease (lesion-based analysis); - Safety / Toxicity profile of 68Ga-PSMA administration (PET radiopharmaceutical) and of Gadoteric Acid / Dotarem administration (MRI contrast agent). COHORT 3b: - mp-3TMRI-based feasibility of mono-/bi-lateral nerve-sparing expressed as the concordance between the feasibility of nerve-sparing approach between mp-3TMRI and surgical evidence; - Safety / Toxicity profile of Gadoteric Acid / Dotarem administration (MRI contrast agent)
    COORTI 1 e 2: Sicurezza e tossicità: profilo di sicurezza/tossicità della somministrazione di 68Ga-PSMA (radiofarmaco PET), di Acido Gadoterico/ Dotarem (agente di contrasto MRI) e delle sessioni di biopsie prostatiche BIOPSTAGE TRUS-guidate (analisi basata su pazienti). COORTE 3A: - Determinare la precisione diagnostica separatamente della 68Ga-PSMA PET/CT e della mp-3TMRI per rilevare e localizzare la malattia N1 (analisi basata sulla lesione); - Sicurezza e tossicità: profilo di sicurezza/tossicità della somministrazione di 68Ga-PSMA (radiofarmaco PET), di Acido Gadoterico/ Dotarem (agente di contrasto MRI).
    COORTE 3b: - Confronto tra la fattibilità chirurgica della NSS mono/bi-laterale e la fattibilità della mp-3TMRI; - Sicurezza e tossicità: profilo di sicurezza/tossicità della somministrazione di Acido Gadoterico/ Dotarem (agente di contrasto MRI).

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    COHORT 1: Men aged 45 to 75 years old with clinically-suspected PCa candidated for either initial or repeat TRUS-guided prostate biopsy; COHORT 2: Men consenting to enter the PRIAS MRI side-study COHORT 3a: Male with cyto/histological confirmation of high risk PCa, willing to undergo radical prostatectomy and pelvic lymph node dissection. COHORT 3b: Male with cyto/histological confirmation of PCa, willing to undergo nerve-sparing radical prostatectomy
    COORTE 1: Uomini con sospetto di PCa clinicamente significativo (CS-PCa), candidati alla biopsia prostatica o dopo la prima biopsia negativa TRUS. COORTE 2: Uomini sottoposti a sorveglianza attiva (studio PRIAS) COORTE 3a: Uomini con PCa ad alto ri-schio (HR-PCa) prima della chirurgia radicale. COORTE 3b: Uomini con diagnosi di CS-PCa prima della chirurgia prostatica nerve-sparing (NSS).
    E.4Principal exclusion criteria
    1. Hormone androgen deprivation therapy of any type within 6 months prior to enrollment.
    2. Prior pelvic radiotherapy;
    3. Sickle cell disease;
    4. Insufficient renal function (eGFR < 30 mL/min/1.73 m2);
    5. Hip prosthesis, vascular grafting or other conditions affecting imaging;
    6. Contraindication to MRI;
    7. History of allergic reactions attributed to compounds of similar chemical or biologic com-position to 68Ga-PSMA or Gadolinium-based contrast agents used in the study.
    8. Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
    1.Terapia di deprivazione androgenica entro 6 mesi dall’ingresso in studio
    2. Radioterapia pelvica precedente;
    3. malattia delle cellule falciformi;
    4. Funzionalità renale insufficiente (eGFR <30 mL / min / 1,73 m2);
    5. Protesi d'anca, innesto vascolare o altre condizioni che interessano l'imaging;
    6. Controindicazione a MRI
    7. Storia di reazioni allergiche attribuite a composti associati chimicamente o biologicamente al 68Ga-PSMA o all'agente di contrasto a base di Gadolinium utilizzati nello studio.
    8. I pazienti trattati con chemioterapia o radioterapia entro 4 settimane dall’ingresso in studio o pazienti che non hanno recuperato da eventi avversi dovuti a precedenti trattamenti somministrati più di 4 settimane prima.
    E.5 End points
    E.5.1Primary end point(s)
    COHORTS 1 and 2: • 68Ga-PSMA PET/CT Sensitivity, Specificity, Positive Predictive Value; Negative Predic-tive Value, Diagnostic Accuracy for clinically-significant PCa (lesion-based and 12-prostate region-based analysis); • mp-3TMRI Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, Diagnostic Accuracy for clinically-significant PCa (lesion-based and 12-prostate re-gion-based analysis). COHORT 3a: To characterize the separate diagnostic accuracy of 68Ga-PSMA PET/CT and 3TMRI for prostate cancer T staging (i.e. prostate and seminal vesicles disease) compared to tissue step-section prostate pathology. COHORT 3b: • T staging accuracy of mp-3TMRI (number, size and site, T2 vs. T3 disease); • N staging accuracy
    COORTI 1 e 2: 68Ga-PSMA PET / CT: sensibilità, specificità, valore predittivo positivo, valore predittivo negativo, precisione diagnostica per PCa clinicamente significativo • mp-3TMRI: sensibilità, specificità, valore predittivo positivo, valore predittivo negativo, precisione diagnostica per PCa clinicamente significativo. COORTE 3a: Caratterizzare separatamente l'accuratezza diagnostica della 68Ga-PSMA PET/CT e della 3TMRI per la stadiazione T del tumore della prostata (malattia della prostata e delle vescicole seminali) rispetto alla valutazione del tessuto prostatico patologico. COORTE 3b: • accuratezza dello staging T della mp-3TMRI (numero, dimensione e siti, T2 vs T3); • accuratezza dello staging N
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 months
    36 mesi
    E.5.2Secondary end point(s)
    COHORT 3b: Safety / Toxicity profile of Gadoteric Acid / Dotarem administration (MRI contrast agent).
    COORTE 3b: profilo di sicurezza/tossicità della somministrazione di Acido Gadoterico/ Dotarem (agente di contrasto MRI).
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 months
    36 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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    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 No
    E.8.2.4Number of treatment arms in the trial4
    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 No
    E.8.5.1Number of sites anticipated in the EEA2
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 186
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state306
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 306
    F.4.2.2In the whole clinical trial 306
    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)
    It is a diagnostic trial, none defined treatment is provided for subjects at the end of study participation
    La sperimentazione è di tipo diagnostico, non prevede alcun trattamento predefinito dei soggetti al termine della partecipazione allo studio
    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 Decision2018-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-15
    P. End of Trial
    P.End of Trial StatusOngoing
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