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    Summary
    EudraCT Number:2017-004332-11
    Sponsor's Protocol Code Number:P.64Cu.002.02
    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:2018-10-04
    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 number2017-004332-11
    A.3Full title of the trial
    Use of 64CuCl2 PET/CT Imaging in the selection of patients with prostate cancer in biochemical relapse after prostatectomy, to be successfully treated with salvage radiotherapy on the prostatic bed
    Utilizzo dell’Imaging PET/CT con 64CuCl2 nella selezione dei pazienti con tumore della prostata in recidiva biochimica dopo prostatectomia, da trattare con successo con radioterapia di salvataggio sul letto prostatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of the diagnostic PET with 64CuCl2 in order to select patients, in which a disease relapse is shown after prostate surgical removal, to be successfully treated to radiation therapy on the prostate bed
    Uso della tecnica diagnostica PET con 64CuCl2 al fine di selezionare pazienti, in cui si è manifestata una ripresa della malattia dopo la rimozione chirurgica della prostata, che risponderanno con successo alla radioterapia sul letto prostatico
    A.3.2Name or abbreviated title of the trial where available
    64CuCl2 PET/CT for cancer on the prostatic bed
    PET/CT con 64CuCl2 per tumore sul letto prostatico
    A.4.1Sponsor's protocol code numberP.64Cu.002.02
    A.5.4Other Identifiers
    Name:N.A.Number:N.A.
    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 SponsorSPARKLE SRL
    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 supportSparkle srl
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSparkle srl
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Addresslocalità cavallino snc
    B.5.3.2Town/ citymontecosaro scalo
    B.5.3.3Post code62010
    B.5.3.4CountryItaly
    B.5.4Telephone number0733560354
    B.5.5Fax number0733560352
    B.5.6E-mailp.panichelli@sparklepet.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 IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLORURO DI RAME (Cu-64)
    D.3.9.2Current sponsor code(64Cu)CuCl2
    D.3.9.3Other descriptive name64Cu(II)Cl2
    D.3.10 Strength
    D.3.10.1Concentration unit Bq/ml becquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number925000000
    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
    cancer on the prostatic bed
    carcinoma su letto prostatico
    E.1.1.1Medical condition in easily understood language
    prostate cancer
    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 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the diagnostic accuracy of PET with 64CuCl2 in the diagnosis of local recurrence (PSA> 0.2, <= 1ng / ml) of prostatic carcinoma after radical prostatectomy, in patients negative to traditional methods.
    L’obiettivo primario è quello di valutare l’accuratezza diagnostica della PET con 64CuCl2 nella diagnosi di recidiva locale (PSA> 0,2, <= 1ng / ml) di carcinoma prostatico dopo prostatectomia radicale, nei pazienti negativi alle metodiche tradizionali.
    E.2.2Secondary objectives of the trial
    1. to evaluate the ability to detect relapse sites in subgroups with PSA <0.5 and between 0.5 and 1;
    2. to evaluate the clinical impact (treatment modification) of cases with positive 64CuCl2-PET in lymph nodes or for distant metastases (M+);
    3. to evaluate all the performance indicators of interest of the 64CuCl2-PET referring to the response after Salvage Radiotherapy
    4. to estimate the median time to reach the minimum value (NADIR) of the PSA in B+ patients;
    5. to evaluate the optimal SUV for the detection of index lesions in the prostate bed;
    6. to evaluate the safety aspects and the surveillance of adverse events.
    1. Valutare la capacità di rilevare siti di recidiva nei sottogruppi con PSA <0.5 e compreso tra 0.5 e 1;
    2. Valutare l’impatto clinico (modificazione del trattamento) dei casi con 64CuCl2-PET positiva nei linfonodi o per metastasi a distanza (M+);
    3. Valutare tutti gli indicatori di performance d’interesse della 64CuCl2-PET facendo riferimento alla risposta dopo SRT;
    4. Stima del tempo mediano al raggiungimento del valore minimo (NADIR) del PSA nei pazienti B+;
    5. Valutare il SUV ottimale per l’individuazione delle lesioni indice nel letto prostatico;
    6. Valutare gli aspetti di sicurezza e la sorveglianza degli eventi avversi.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. >=45 years old at the moment of enrolment in the study
    2. Previous documented histological diagnosis of primitive prostate adenocarcinoma
    3. Prior radical prostatectomy surgery
    4. Zeroing of the circulating PSA values
    5. Presence of biochemical relapse documented by circulating PSA values raising in two consecutive determinations performed within three weeks of distance (values over 0.2ng / ml and lower than 1.1 ng /ml)
    6. Absence of distant metastatic lesions not shown by previous mpMRI and PET / CT-18F-choline tests
    7. Negative clinical history for other pre-existing or current neoplastic diseases, with the exception of non-melanoma skin cancers
    8. Previous execution of 18F-FCH-PET not older than 30 days
    9. Patients to be treated with rescue radiotherapy on the prostatic bed
    10. Previous execution of mpMRI not older than 30 days
    11. Karnofski’s Index ≥ 80%
    12. Absence of other relevant co-morbidities (see: exclusion criteria)
    13. Full ability to understand the information in the informed consent sheet
    14. Full ability to sign informed consent
    1. Età>=45 anni al momento dell’arruolamento
    2. Pregressa diagnosi istologica, documentabile, di adenocarcinoma primitivo della prostata
    3. Pregresso intervento chirurgico di prostatectomia radicale
    4. Azzeramento dei valori di PSA circolante
    5. Presenza di recidiva biochimica documentata da innalzamento dei valori del PSA circolante in due determinazioni eseguite consecutivamente al massimo entro tre settimane di distanza (valori oltre i 0.2ng/ml ed inferiori a 1.1 ng/ml)
    6. Assenza di lesioni metastatiche a distanza non evidenziabili da precedenti esami di mpMRI e PET/CT-18F-colina
    7. Storia clinica negativa per altre patologie neoplastiche pregresse od in atto, con l’eccezione di carcinomi cutanei non-melanoma
    8. Precedente esecuzione di 18F-FCH-PET non più vecchia di 30 giorni
    9. Pazienti da trattare con radioterapia di salvataggio sul letto prostatico
    10. Precedente esecuzione di mpMRI non più vecchia di 30 giorni
    11. Indice di Karnofski ≥ 80%
    12. Assenza di altre comorbilità rilevanti (cfr: criteri di esclusione)
    13. Piena capacità di comprendere le informazioni riportate nella documentazione illustrativa per il Soggetto
    14. Piena capacità di sottoscrivere il consenso informato
    E.4Principal exclusion criteria
    1. Anemia with Hb <9 gr / dl
    2. Subject treated with ADT (orchiectomy, and / or LHRH agonists, and / or androgen antagonists)
    3. Presence of symptoms or signs of sepsis and / or evidence of acute infections
    4. AST> 1.5 times the upper limit of the normal range
    5. ALT> 1.5 times the upper limit of the normal range
    6. Total bilirubin> 1.5 times the upper limit of the normal range
    7. Clinical history and / or previous serological evidence for HBV infection
    8. Clinical history and / or previous serological evidence for HCV infection
    9. copper metabolism diseases (Menkes’ disease, Wilson’s disease)
    10. Subjects who have received chemotherapy in the previous 120 days
    11. Radiotherapy performed in the previous 120 days
    12. Major surgery performed in the previous 120 days
    13. Presence of lesions in the prostatic bed evidenced by previous mpMRI and / or US examinations
    14. Previous participation in clinical trials with exposure to ionizing radiation for therapeutic purposes
    15. 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
    16. Inability to understand the contents of the information documentation for the subject
    1. Anemia con Hb<9 gr/dl
    2. Soggetto in trattamento con ADT (orchiectomia, e/o agonisti LHRH, e/o antagonisti degli androgeni)
    3. Presenza di sintomi o segni di sepsi e/o evidenza di infezioni acute
    4. AST >1.5 volte il limite superiore del range di normalità
    5. ALT >1.5 volte il limite superiore del range di normalità
    6. Bilirubina totale > 1.5 volte il limite superiore del range di normalità
    7. Storia clinica e/o pregressa evidenza sierologica per infezione HBV
    8. Storia clinica e/o pregressa evidenza sierologica per infezione HCV
    9. Malattie del metabolismo del rame (m. di Menkes, m.di Wilson)
    10. Soggetti che abbiano ricevuto Chemioterapia nei 120 gg precedenti
    11. Radioterapia effettuata nei 120 gg precedenti
    12. Chirurgia maggiore effettuata nei 120 gg precedenti
    13. Presenza nel letto prostatico, di lesioni evidenziabili da precedenti esami di mpMRI e/o US
    14. Precedente partecipazione a trials clinici con esposizione a radiazioni ionizzanti a scopo terapeutico
    15. Qualsiasi condizione, materiale, logistica, o Soggettiva, che, anche a giudizio dello Sperimentatore Principale, possa condizionare la compliance del Soggetto alla esecuzione delle procedure previste dal Protocollo
    16. Incapacità a comprendere il contenuto della documentazione informativa per il Soggetto
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the relationship between PSA levels (calculated between PSA levels measured before treatment and minimum PSA level measured during the observational period following the treatment) and prostatic bed (positive prostate (B +) and negative prostate (B-). The 64CuCl2-PET is obtained positive (B +) when in the prostate bed a detectable focal absorption is manifested because superior to the value of the background; otherwise it is judged negative (B-) The SRT response is defined as positive (R +) if a PSA decrease of ≥15% respect to the initial PSA value otherwise the SRT response is defined as negative (R -). It will be considered true positive patients (B+)(R+) and true negatives (B-)(R-).
    Valutare la relazione tra la variazione percentuale di PSA (calcolata come differenza tra il valore PSA misurato prima del trattamento e il livello minimo di PSA misurato nei tempi di osservazione successivi all’inizio del trattamento) e il letto prostatico (letto prostatico positivo (B+) e letto prostatico negativo (B-). La 64CuCl2-PET viene valutata positiva (B+) quando nel letto prostatico si manifesta una uptake focale rilevabile perché superiore al valore del fondo; viene altrimenti giudicata negativa (B-) La risposta SRT viene definita come positiva (R+) se si verifica una diminuzione ≥15% del valore del PSA prima dell’inizio della SRT e valutata come negativa (R-) se non si verifica una diminuzione di almeno il 15%.
    Verranno considerati VP (veri positivi) i casi (B+)(R+) e VN (veri negativi) i casi (B-)(R-).
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 weeks, 10 weeks and 4 months since the beginning of radiotherapy.
    5 settimane, 10 settimane e 4 mesi dall'inizio della radioterapia
    E.5.2Secondary end point(s)
    1) Calculation of the maximum variation of PSA in the subgroups of patients with PSA <0.5 and PSA between 0.5 and 1, through the ROC curve and evaluation of the ability to detect sites of recurrence
    2) In each patient the impact that the positive results of 64CuCl2-PET out of the prostatic bed would have had on the therapeutic choice will be evaluated and tabulated, also taking into account the classification of the patient in R + / R-;
    3) Sensitivity, specificity, positive and negative predictive values and area under the curve (AUC) will be evaluated.
    4) The time between treatment beginning (baseline) and the achievement of the minimum value (NADIR) will be estimated through estimates of Kaplan-Meyer curves.
    5) The SUV values of the prostate bed index lesions will be correlated with the actual SRT response, in order to identify the SUV limits below which the uptake is not significant
    6) Adverse events will be recorded and classified according to the EMA guidelines.
    1) Calcolo della variazione massima di PSA nei sottogruppi di pazienti con PSA<0.5 e PSA compreso tra 0.5 e 1, mediante la curva ROC e valutazione della capacità di rilevare siti di recidiva
    2) In ciascun paziente verrà valutato e tabulato l'impatto che avrebbe avuto sulla scelta terapeutica la presenza di risultati positivi della 64CuCl2-PET fuori del letto prostatico, anche tenendo conto della classificazione del paziente in R+/R-;
    3) Verrà valutata sensibilità, specificità, valori predittivi positivi e negativi e area sotto la curva (AUC).
    4) Verranno stimati i tempi che intercorrono tra l’inizio del trattamento (basale) ed il raggiungimento del valore minimo (NADIR) mediante stime delle curve di Kaplan-Meyer.
    5) Verranno correlati i valori dei SUV delle lesioni indice del letto prostatico con l’effettiva risposta alla SRT, al fine di identificare i limiti di SUV al di sotto dei quali la captazione non è significativa
    6) Verranno registrati e classificati gli eventi avversi, secondo le direttive EMA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at trial completion
    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 Yes
    E.6.5Efficacy Yes
    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 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.8.3 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.8.5.1Number of sites anticipated in the EEA5
    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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state138
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 138
    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 routinary clinical practice
    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 Decision2018-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-16
    P. End of Trial
    P.End of Trial StatusOngoing
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