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    Summary
    EudraCT Number:2019-000744-10
    Sponsor's Protocol Code Number:P.64Cu.003.01
    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:2020-10-08
    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 number2019-000744-10
    A.3Full title of the trial
    Higher diagnostic accuracy of 64Cu PET/CT compared to standard 18F-choline PET/CT in the detection rate of metastasis from prostate cancer.
    Phase III multicenter, sponsored, interventional "open-label" clinical study, with prospective enrollment.
    Maggior accuratezza diagnostica della PET/CT con 64CuCl2 rispetto alla PET/CT con 18F-colina nella diagnosi di metastasi in pazienti con carcinoma della prostata

    Studio clinico di fase III multicentrico, sponsorizzato, interventistico “open-label”, ad arruolamento prospettico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    better diagnostic accuracy and ability to detect multiple metastases of the PET exam with a new experimental radiopharmaceutical (64CuCl2) in the diagnosis of metastases in patients with prostate cancer compared to the PET / CT examination performed with 18F-choline.
    migliore accuratezza diagnostica e capacità di rilevare più metastasi dell’esame PET con un nuovo radiofarmaco sperimentale (64CuCl2) nella diagnosi di metastasi in pazienti con carcinoma della prostata, rispetto all'esame PET/CT eseguito con 18F-colina.
    A.3.2Name or abbreviated title of the trial where available
    64CuCl2 PET/CT VS 18F-choline PET/CT in prostate cancer
    64CuCl2 PET/CT VS 18F-colina PET/CT in pazienti affetti da carcinoma prostatico
    A.4.1Sponsor's protocol code numberP.64Cu.003.01
    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 SponsorA.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L.
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationA.C.O.M. S.R.L.
    B.5.2Functional name of contact pointUfficio amministrativo
    B.5.3 Address:
    B.5.3.1Street AddressLocalità cavallino
    B.5.3.2Town/ cityMontecosaro
    B.5.3.3Post code62010
    B.5.3.4CountryItaly
    B.5.4Telephone number0733229739
    B.5.5Fax number0733560352
    B.5.6E-mailamministrazione@acompet.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 name64-Rame Cloruro
    D.3.2Product code [64Cu(II)Cl2]
    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 INNRame cloruro (64CuCl2)
    D.3.9.2Current sponsor code(64Cu)CuCl2
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number925
    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
    Prostate cancer at risk of developing metastatic lesions
    Carcinoma prostatico a rischio di sviluppo lesioni metastatiche
    E.1.1.1Medical condition in easily understood language
    Prostate cancer with the risk of developing metastasis
    Tumore della prostata con rischio di sviluppare metastasi
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    The study design is based on a co-primary endpoint for the evaluation of diagnostic performance in terms of sensitivity and specificity of 64Cu PET/CT compared to 18F-choline PET/CT. The assessment of sensitivity and specificity for the co-primary endpoint is expressed on a patient basis, in relation to the whole individual.
    Il disegno di studio si basa su un endpoint co-primario per la valutazione della performance diagnostica in termini di sensibilità e specificità della 64Cu PET/CT rispetto a 18F-colina PET/CT. La valutazione della sensibilità e specificità per l’endpoint coprimario è espressa su base paziente, in relazione all’intero individuo.
    E.2.2Secondary objectives of the trial
    1. to evaluate the higher diagnostic accuracy of 64CuCl2 PET/CT in the identification of metastases compared to 18F-choline PET/CT (diagnostic performance);
    2. estimate the sensitivity and specificity between the two PET/CT scans (64CuCl2 and 18F choline) on a regional basis (chest, abdomen, pelvis) and on a lesion basis (bone, lymph nodes and visceral) (diagnostic performance);
    3. Correlate the sensitivity of 64CuCl2 PET/CT and 18F choline PET/CT to different PSA levels (diagnostic performance);
    1. valutare la maggiore accuratezza diagnostica di 64Cu(II)Cl2 PET/CT nell’identificazione di metastasi rispetto a 18F-colina PET/CT (performance diagnostica);
    2. stimare la sensibilità e la specificità tra le due PET/CT (64Cu(II)Cl2 e 18F colina) su base regione (torace, addome, bacino) e su base lesione (osso, linfonodi e viscerali) (performance diagnostica);
    3. Correlare la sensibilità di 64Cu(II)Cl2 PET/CT e 18F colina PET/CT a diversi livelli di PSA (performance diagnostica);
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age >=45 years at the enrollment time
    2. Documented hystologically diagnosis of PCa
    3. Clinical indication to staging or restaging
    4. Imaging of MRI and/or TAC and/or bone scintigraphy and/or PET and/or other imaging techniques
    5. Patient at risk of developing metastasis during their illness according symptoms presence or EAU criteria of risk as follows:
    • At diagnosis : PSA > 20 or GS > 7 or cT2c; or any PSA –any Gs cT3-4 or cN+;
    • At restaging after primary treatment: PSA 0.2 ng/ml or PSA increase of 2ng/ml;
    • After-staging for biochemical progression during treatment: 3 PSA assay demonstrating an increase > 50% respect to nadir and a PSA > 2 ng/ml.
    6. No other concomitant or previous malignant tumors, except for non-melanoma skin cancers
    7. Karnofski index = 80%
    8. No other relevant disease (cfr exclusion criteria)
    9. Ability to understand the contents of the information material for the subject
    10. Ability to sign the Informed consent
    1. Età>=45 anni al momento dell’arruolamento.
    2. pPregressa diagnosi istologica, documentabile, di adenocarcinoma primitivo della prostata.
    3. Indicazione clinica sulla stadiazione o alla ristadiazione.
    4. Esami di Imaging MRI e/o TAC e/o di scintigrafia ossea non più vecchi di 30 giorni e/o PET e/o altre metodiche di imaging .
    5. Pazienti a rischio di sviluppare metastasi durante la loro malattia in base alla presenza di sintomi o ai criteri di rischio EAU come segue:
    Classe A: pazienti ad alto rischio prima del trattamento primario: PSA> 20 o GS> 7 o cT2c; o qualsiasi PSA anche Gs cT3-4 o cN +, conferma istologica nella prostata e nei linfonodi (se possibile), per i pazienti che non hanno già iniziato la radioterapia.
    Classe B: pazienti alla ristadiazione dopo il trattamento primario: valore del PSA 0,2 ng / ml in due diverse misurazioni consecutive oppure aumento del PSA sierico di 2 ng / ml rispetto al valore nadir del PSA.
    Classe C: post-stadiazione per progressione biochimica, durante il trattamento (CRPC); tre aumenti consecutivi del PSA ad almeno una settimana di distanza l'uno dall'altro, risultanti in due aumenti del 50% oltre il nadir e un PSA> 2ng / ml.
    6. Storia clinica negativa per altre patologie neoplastiche pregresse od in atto, con l’eccezione di carcinomi cutanei non-melanoma.
    7. iIndice di Karnofski = 80%.
    8. Assenza di altre comorbillità rilevanti (cfr: criteri di esclusione).
    9. Piena capacità di comprendere le informazioni riportate nella documentazione illustrativa per il Soggetto.
    10. Piena capacità di sottoscrivere il consenso informato.
    E.4Principal exclusion criteria
    1. Anemia (Hb<9 gr/dl)
    2. Symptoms or signs of sepsis and / or evidence of acute infections
    3. AST >1.5 higher than normal range
    4. ALT >1.5 higher than normal range
    5. Total bilirubin > 1.5 higher than normal range
    6. Copper metabolism disease (m.di Menkes, m.di Wilson)
    7. Previous participation in trials with exposure to ionizing radiation for therapeutic purposes
    8. Any condition, material, logistics, or Subjective, which, even in the opinion of the Principal Investigator, may condition the subject's compliance with the execution of the procedures established by the Protocol
    9. Inability to understand the contents of the information documentation for the subject
    1. Anemia con Hb<9 gr/dL
    2. Presenza di sintomi o segni di sepsi e/o evidenza di infezioni acute
    3. AST >1.5 volte il limite superiore del range di normalità
    4. ALT >1.5 volte il limite superiore del range di normalità
    5. Bilirubina totale > 1.5 volte il limite superiore del range di normalità
    6. Malattie del metabolismo del rame (m.di Menkes, m.di Wilson)
    7. Precedente partecipazione a trials clinici con esposizione a radiazioni ionizzanti a scopo terapeutico
    8. Qualsiasi condizione, materiale, logistica, o Soggettiva, che, anche a giudizio dello Sperimentatore Principale, possa condizionare la compliance del Soggetto alla esecuzione delle procudure previste dal Protocollo
    9. Incapacità a comprendere il contenuto della documentazione informativa per il Soggetto
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the diagnostic performance in terms of sensitivity and specificity of 64Cu PET/CT compared to 18F-choline PET/CT on a patient basis, in relation to the whole individual.
    In particular, 18F-choline PET/CT and 64CuCl2 PET/CT will be evaluated as positive (PET+) in case of evidence of pathological focal uptake at site(s) compatible with metastases (bone, lymph node and visceral; they will otherwise be judged negative (PET-) when no pathological focal uptake is detectable.
    Valutare la performance diagnostica in termini di sensibilità e specificità della 64Cu PET / CT rispetto a 18F-colina PET / CT su base paziente, in relazione all’intero individuo.
    In particolare, la 18F-colina PET / CT e la 64CuCl2 PET / CT verranno valutate come positive (PET+) in caso di evidenza di uptake focale patologico in corrispondenza di sede/i compatibili con metastasi (ossee, linfonodali e viscerali ; verranno altrimenti giudicate negative (PET-) quando non sono evidenziabili uptake focali patologici.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of trial
    a fine studio
    E.5.2Secondary end point(s)
    1. The diagnostic accuracy of the two PET/CT scans (64Cu and 18F-choline) will be assessed by area under the ROC curve (AUC) and the difference of the curve between the two methods will be assessed,
    2. Lesion-based and region-based sensitivity and specificity will be analyzed by aggregation according to body region (thorax, abdomen, pelvis) and anatomical-pathological character of lesions (bone, lymph nodes, visceral)
    3. 64Cu PET and 18F-choline sensitivity will be correlated with PSA levels and calculated as per the primary objective,
    4. Patients will be classified into non-metastatic, oligometastatic and multimetastatic with both PET/CT. (oligometastatic will be defined as a patient with a maximum number of three metastases),
    5. In each patient, the different impact determined by the two PETs on decision thinking (impact of the test compared to the pre-test probability) will be evaluated with calculation of positive and negative predictive values,
    6. In each patient, the impact determined by the 64Cu PET/CT on the clinical outcome will be evaluated by means of the patient's follow-up data and in particular the consequences of a misdiagnosis (delay of treatment or unnecessary interventions) will be evaluated,
    7. The inter-observer reproducibility of 64CuCl2 and 18F-FCH PET/CT will be evaluated.
    1. L'accuratezza diagnostica delle due PET/CT (64Cu e 18F-colina) verrà valutata mediante area sotto la curva ROC (AUC) e verrà valutata la differenza della curva tra le due metodiche,
    2. La sensibilità e la specificità su base-lesione e su base-regione saranno analizzate mediante aggregazione secondo regione del corpo (torace, addome, bacino) e carattere anatomo-patologico delle lesioni (ossee, linfonodali, viscerali)
    3. La sensibilità 64Cu PET e 18F-colina verrà correlata ai livelli di PSA e calcolata come per l’obbiettivo primario,
    4. Verranno classificati i pazienti in non-metastatici, oligometastatici e plurimetastatici con entrambe le due PET/CT. (verrà definito oligometastatico il paziente con un numero massimo di tre metastasi),
    5. In ciascun paziente verrà valutato il diverso impatto determinato dalle due PET sul pensiero decisionale (impatto del test rispetto alla probabilità pre-test) con calcolo dei valori predittivi positivi e negativi,
    6. In ciascun paziente verrà valutato l’impatto determinato dalla 64Cu PET/CT sull'esito clinico mediante i dati di follow-up del paziente e in particolare saranno valutate le conseguenze di una diagnosi errata (ritardo del trattamento o interventi non necessari),
    7. Verrà valutata la riproducibilità inter- osservatore delle 64CuCl2 e 18F-FCH PET/CT.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of trial
    a fine studio
    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 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 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 Yes
    E.8.2.3.1Comparator description
    18F-colina
    18F-choline
    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 concerned5
    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 months2
    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 months2
    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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state285
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 285
    F.4.2.2In the whole clinical trial 285
    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)
    According to clinical practice routin
    Come da 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 Decision2019-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-26
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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