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    Summary
    EudraCT Number:2012-001685-15
    Sponsor's Protocol Code Number:ANTI-3-18F-FACBC
    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:2012-08-07
    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 number2012-001685-15
    A.3Full title of the trial
    ANTI-3-18F-FACBC IN COMPARISON TO 11C-CHOLINE PET/CT IN THE EVALUATION OF PATIENTS WITH SUSPECT PROSTATE CANCER RELAPSE
    ANTI-3-18F-FACBC (anti1-amino-3-18F-fluorocyclobutane-1-carbossilico) rispetto alla 11C-colina PET / TC nella valutazione dei pazienti con sospetta ripresa di carcinoma prostatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ANTI-3-18F-FACBC IN COMPARISON TO 11C-CHOLINE PET/CT IN THE EVALUATION OF PATIENTS WITH SUSPECT PROSTATE CANCER RELAPSE
    ANTI-3-18F-FACBC (anti1-amino-3-18F-fluorocyclobutane-1-carbossilico) rispetto alla 11C-colina PET / TC nella valutazione dei pazienti con sospetta ripresa di carcinoma prostatico
    A.3.2Name or abbreviated title of the trial where available
    ANTI-3-18F-FACBC
    ANTI-3-18F-FACBC
    A.4.1Sponsor's protocol code numberANTI-3-18F-FACBC
    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 SponsorAZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
    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 supportGE Healthcare, UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU di Bologna, Policlico S.Orsola-Malpighi
    B.5.2Functional name of contact pointU.O. Medicina nucleare-C.Nanni
    B.5.3 Address:
    B.5.3.1Street AddressVia Albertoni 15
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.4Telephone number051/6363187
    B.5.5Fax number051/6363956
    B.5.6E-mailcristina.nanni@aosp.bo.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 nameANTI-3-18F-FACBC
    D.3.2Product code ANTI-3-18F-FACBC
    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 INNl’anti-1-amino-3-fluorine 18-fluorocyclobutane-1-carboxylic acid
    D.3.9.2Current sponsor codeanti-3-18F-FACBC
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/kg megabecquerel(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
     Patients with prostate cancer treated with radical prostatectomy or radiotherapy presenting with suspect progression(rising PSA) of local or distant (lymphnodes or bones) already scheduled for a 11C-Choline PET/CT (performed at enrolment and during the follow-up)
    pazienti con cancro prostatico trattati con prostatectomia radicale e/o radioterapia che presentano sospetto biochimico (PSA) di recidiva (locale e/o linfonodale e/o ossea) e per tale motivo sottoposti nell’ambito del consolidato percorso assistenziale, all’esame PET/TC con 11C-colina
    E.1.1.1Medical condition in easily understood language
     Patients with prostate cancer treated with radical prostatectomy or radiotherapy presenting with suspect progression(rising PSA) of local or distant (lymphnodes or bones)
    pazienti con cancro prostatico trattati con prostatectomia radicale e/o radioterapia che presentano sospetto biochimico (PSA) di recidiva (locale e/o linfonodale e/o ossea)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10036908
    E.1.2Term Prostatic neoplasms malignant
    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
     Evaluate: Anti-3-18F-FACBC PET/CT sensitivity in comparison to 11C-Choline PET/CT for the detection of disease relapse
     Valutare la sensibilità della Anti-3-18F-FACBC PET/TC rispetto alla 11C-colina nell’identificare la ripresa di malattia
    E.2.2Secondary objectives of the trial
     Evaluate: the predictive value Anti-3-18F-FACBC PET/CT in comparison to disease evolution.
     Evaluate: the specificity and accuracy of Anti-3-18F-FACBC PET/CT. Compare the Anti-3-18F-FACBC PET/CT results and biochemical parameters, imaging procedures and clinical visits at enrolment and during the follow-up
     Valutare il valore predittivo della PET/TC con Anti-3-18F-FACBC rispetto all’andamento della malattia.
     Valutare e confrontare la specificità e l’accuratezza diagnostica dell’ Anti-3-18F-FACBC PET/TC,con i risultati ottenuti dalle indagini biochimiche,cliniche e strumentali eseguite alla valutazione basale e al follow-up
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • prostate cancer treated with radical prostatectomy or radiotherapy at least 3 months before.
    • recurrent prostate carcinoma suspected on the basis of previous American Society for Radiology and Oncology (ASTRO) criteria of three consecutive increases in PSA level, the ASTRO-Phoenix criteria of an increase in PSA level of at least 2.0 ng/mL above the nadir level after radiation therapy, and/or an absolute PSA level of 0.3 mg/mL or greater after prostatectomy
    • patients who have already performed conventional imaging tests (MR, CT, 11C-Choline PET/CT)
    • age ≥ 18 years
    • signed informed consent
    • pazienti affetti da carcinoma prostatico trattati con prostatectomia radicale e/o radioterapia da almeno tre mesi
    • pazienti con sospetto clinico di ripresa di malattia in accordo con i criteri proposti dall’American Society of Radiology and Oncology: tre aumenti consecutivi del PSA, oppure un aumento del PSA di almeno 2,0 mg/mL al di sopra del livello nadir dopo radioterapia, e/o un livello assoluto di PSA di 0,3 mg/mL o maggiore dopo prostatectomia
    • pazienti già sottoposti ad esami di imaging convenzionale (RM, TC, 11C-Colina PET/TC)
    • età ≥ 18 anni
    • firma del consenso informato
    E.4Principal exclusion criteria
    • radical prostatectomy or radiation therapy performed within 3 months
    • age <18
    • patients of un sound mind
    • pazienti sottoposti a prostatectomia radicale e/o radioterapia da meno di tre mesi.
    • età &lt;18
    • soggetti non in grado di fornire un valido consenso informato
    E.5 End points
    E.5.1Primary end point(s)
     Compare in terms of positivity/negativity the results of Anti-3-18F-FACBC PET/CT and 11C-Choline PET/CT at enrolment and during the follow-up
     Confronto tra i risultati in termini di positività/negatività dell’esame PET/TC eseguito con Anti-3-18F-FACBC e quello eseguito con 11C-Colina al basale e al follow-up
    E.5.1.1Timepoint(s) of evaluation of this end point
    at time one (1 single administration IMP-1) and after 12 months of follow-up (time two)
    a tempo uno (1 singola somministrazione dell'IMP-1) e dopo 12 mesi di Follow-up (tempo 2)
    E.5.2Secondary end point(s)
     Compare the results of Anti-3-18F-FACBC PET/CT in terms of positivity/negativity and progression free survival.
     Specificity and accuracy of Anti-3-18F-FACBC PET/CT having as gold standard the routine tests performed at enrolment and during the follow-up
     Confronto tra i risultati dell’esame PET/TC con Anti-3-18F-FACBC in termini di positività/negatività e periodo libero da progressione.
     Specificità e accuratezza della PET/TC con Anti-3-18F-FACBC alla luce dei risultati ottenuti dalle indagini routinariamente condotte in questi pazienti sia al basale che al follow-up
    E.5.2.1Timepoint(s) of evaluation of this end point
    at time one (1 single administration IMP-1) and after 12 months of follow-up (time two)
    a tempo uno (1 singola somministrazione dell'IMP-1) e dopo 12 mesi di Follow-up (tempo 2)
    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) 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 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 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 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
    The study forsees a single administration of the radiopharmaceutical with follow-up after 12 months.
    Lvls is the last visit - the last patient follow-up visit.
    Lo studio prevede 1 sola somministrazione del radiofarmaco con follow-up dopo 12 mesi.
    LVLS corrisponde all'ultima vista di follow-up dell'ultimo paziente.
    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 months24
    E.8.9.1In the Member State concerned 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state100
    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)
    Not applicable
    Non applicabile.
    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 Decision2012-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-17
    P. End of Trial
    P.End of Trial StatusOngoing
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