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    Summary
    EudraCT Number:2012-004297-26
    Sponsor's Protocol Code Number:1632/12
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-16
    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 number2012-004297-26
    A.3Full title of the trial
    Phase III clinical study of PET-TC with [18f]Fluoroethyilcholine ([18f]Fech) in prostate cancer: assessment of the additional role with respec to conventional imaging techniques
    PET-TC con il radiofarmaco [18f]fluoroetilcolina ([18f]FECh) nel carcinoma prostatico: valutazione del ruolo aggiuntivo rispetto alle tecniche di diagnostica convenzionalmente utilizzate
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III clinical study of PET-TC with [18f]Fluoroethyilcholine ([18f]Fech) in prostate cancer: assessment of the additional role with respec to conventional imaging techniques
    PET-TC con il radiofarmaco [18f]fluoroetilcolina ([18f]FECh) nel carcinoma prostatico: valutazione del ruolo aggiuntivo rispetto alle tecniche di diagnostica convenzionalmente utilizzate
    A.4.1Sponsor's protocol code number1632/12
    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 SponsorPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    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 supportPOLICLINICO GEMELLI
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPoliclinico Gemelli
    B.5.2Functional name of contact pointIst. Medicina Nucleare
    B.5.3 Address:
    B.5.3.1Street AddressLgo Gemelli 8
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number06 30154978
    B.5.5Fax number06 3058185
    B.5.6E-mailA.GIORDANO@RM.UNICATT.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 nameFECh
    D.3.2Product code NA
    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 INNCHOLINE
    D.3.9.1CAS number 62-49-7
    D.3.9.4EV Substance CodeSUB13349MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mCi millicurie(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    carcinoma prostata
    E.1.1.1Medical condition in easily understood language
    prostate cancer:
    carcinoma prostata
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    1. to evaluate the diagnostic efficacy –in terms of sensitivity, specificity and accuracy- of PET-TC with [18F]Fluoroethyilcholine ([18F]FECh) with respect to the other diagnostic imaging techniques that are routinely used such as ultrasonography with trans-rectal probe, computed tomography (CT), magnetic resonance (MR) and bone scintigraphy in: a. patients with known prostate cancer, in whom 18F]FECh PET-TC is performed to evaluate loco-regional or distant disease extension (staging); b. patients previously treated for prostate cancer who present at follow-up elevated PSA levels, in whom 18F]FECh PET-TC is performed to localize the neoplastic lesions.
    Obiettivo primario del programma di ricerca è la valutazione dell’accuratezza diagnostica -in termini di sensibilità e specificità dell’esame PET-CT con [18F]-FECh rispetto alle altre metodiche (ecografia endo-rettale, RM, scintigrafia ossea) in: A) pazienti con recente diagnosi di neoplasia prostatica nei quali l’esame è eseguito al fine di valutare l’estensione di malattia a livello loco-regionale e a distanza (stadiazione); B) pazienti già sottoposti a trattamento chirurgico o radioterapico per neoplasia prostatica e che presentano nel follow-up valori elevati di PSA, nei quali l’esame è eseguito al fine di localizzare le lesioni neoplastiche (ristadiazione).Determinazione del valore aggiunto della metodica rispetto al percorso diagnostico standard.
    E.2.2Secondary objectives of the trial
    Secondary endpoint of the research program is to assess if a PSA doubling time < 3 months can predict the presence of disease.
    Obiettivo secondario è valutare se il tempo di raddoppiamento del valore del PSA &lt; 3 mesi è indicativo di buona probabilità di rivelare la presenza di malattia. valutazione del valore minino delle dimensioni delle lesioni individuate all`esame PET-TC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria: - adult male patients with a) known untreated prostate cancer (biopsy); b) biochemical recurrence of prostate cancer after prostatectomy (PSA> 1 ng/ml or PSA doubling time < 3 months); - availability to participate to the study (informed consent); - patients suitable for the diagnostic procedure (PET-TC with 18F-FECh);
    Criteri d’inclusione: - diagnosi accertata di carcinoma prostatico in pazienti giunti per valutazione specialistica presso il Policlinico A. Gemelli, non sottoposti ad alcuna terapia (fase di stadiazione) già valutati con ecografia endo-rettale o Risonanza Magnetica e scintigrafia scheletrica (per PSA &gt; 10 ng/ml); - recidiva biochimica di neoplasia prostatica dopo prostatectomia o radioterapia con valori di PSA &gt; 1 ng/ml o tempo di raddoppiamento del PSA &lt; 3 mesi; - disponibilità a partecipare allo studio espressa attraverso un consenso informato; - pazienti in grado di essere sottoposti alla procedura diagnostica prevista (PET-TC con [18F]FECh).
    E.4Principal exclusion criteria
    Exclusion criteria: - patients with recent diagnosis of prostate cancer who started hormone therapy; - patients not suitable for the study protocol;
    Criteri d’esclusione: - pazienti con diagnosi recente di tumore prostatico che hanno già iniziato la terapia ormonale; - pazienti in follow-up in corso di terapia ormonale e con PSA in diminuzione; - pazienti non in grado di essere sottoposti alla procedura diagnostica prevista (PET-TC con [18F]FECh).
    E.5 End points
    E.5.1Primary end point(s)
    1. to evaluate the diagnostic efficacy –in terms of sensitivity, specificity and accuracy- of PET-TC with [18F]Fluoroethyilcholine ([18F]FECh) with respect to the other diagnostic imaging techniques that are routinely used such as ultrasonography with trans-rectal probe, computed tomography (CT), magnetic resonance (MR) and bone scintigraphy in: a. patients with known prostate cancer, in whom 18F]FECh PET-TC is performed to evaluate loco-regional or distant disease extension (staging); b. patients previously treated for prostate cancer who present at follow-up elevated PSA levels, in whom 18F]FECh PET-TC is performed to localize the neoplastic lesions.
    Obiettivo primario del programma di ricerca è la valutazione dell’accuratezza diagnostica -in termini di sensibilità e specificità dell’esame PET-CT con [18F]-FECh rispetto alle altre metodiche (ecografia endo-rettale, RM, scintigrafia ossea) in: A) pazienti con recente diagnosi di neoplasia prostatica nei quali l’esame è eseguito al fine di valutare l’estensione di malattia a livello loco-regionale e a distanza (stadiazione); B) pazienti già sottoposti a trattamento chirurgico o radioterapico per neoplasia prostatica e che presentano nel follow-up valori elevati di PSA, nei quali l’esame è eseguito al fine di localizzare le lesioni neoplastiche (ristadiazione).
    E.5.1.1Timepoint(s) of evaluation of this end point
    time 0
    tempo 0
    E.5.2Secondary end point(s)
    Secondary endpoint of the research program is to assess if a PSA doubling time < 3 months can predict the presence of disease.
    Obiettivo secondario è valutare se il tempo di raddoppiamento del valore del PSA < 3 mesi è indicativo di buona probabilità di rivelare la presenza di malattia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    time 0
    tempo o
    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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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 No
    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 years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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: 0
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    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 state750
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 750
    F.4.2.2In the whole clinical trial 750
    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)
    na
    na
    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 Decision2012-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-25
    P. End of Trial
    P.End of Trial StatusCompleted
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