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    The EU Clinical Trials Register currently displays   42564   clinical trials with a EudraCT protocol, of which   7007   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-003165-15
    Sponsor's Protocol Code Number:FACBC-STAGING-2014
    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:2014-08-27
    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 number2014-003165-15
    A.3Full title of the trial
    18F-FACBC PET/CT FOR STAGING HIGH RISK PROSTATE CANCER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    18F-FACBC PET/CT FOR STAGING HIGH RISK PROSTATE CANCER
    A.3.2Name or abbreviated title of the trial where available
    FACBC-STAGING-2014
    FACBC-STAGING-2014
    A.4.1Sponsor's protocol code numberFACBC-STAGING-2014
    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 SponsorAOU di Bologna Policlinico S.Orsola-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 supportPubblic Research found (PRUa1GR-2013-00000171)
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU di Bologna Policlinico S.Orsola-Malpighi
    B.5.2Functional name of contact pointU.O. Medicina Nucleare P.I. Dr.ssa
    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 number00390516363185
    B.5.6E-mailluciaronic@otmail.com
    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 namefluciclovine
    D.3.2Product code 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.3.11 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 affected by moderate to high risk primary prostate cancer who are scheduled for surgery with a planned, elective lymph node dissection
    Pazienti affetti da carcinoma prostatico a rischio moderato-alto, già in nota operatoria per prostatectomia radicale e linfoadenectomia pelvica
    E.1.1.1Medical condition in easily understood language
    Patients affected by moderate to high risk primary prostate cancer who are scheduled for surgery with a planned, elective lymph node dissection
    Pazienti affetti da carcinoma prostatico a rischio moderato-alto, già in nota operatoria per prostatectomia radicale e linfoadenectomia pelvica
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10036946
    E.1.2Term Prostatic cancer
    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
     To evaluate the accuracy of 18F-FACBC PET/CT for preoperative lymph node staging in moderate to high risk prostate cancer patients who are already scheduled for prostatectomy and pelvic lymph node dissection
    • Valutare l’accuratezza diagnostica della PET/TC con 18F-FACBC nella stadiazione linfonodale preoperatoria di pazienti affetti da carcinoma della prostata a rischio moderato-alto, già in nota operatoria per prostatectomia radicale e linfoadenectomia pelvica
    E.2.2Secondary objectives of the trial
    • To evaluate 18F-FACBC performance respect to standard clinical predictive factors of disease (e.g. age, psa, gleason score,tumor stage, choline PET/CT results).
    • To calculate 18F-FACBC sensitivity and specificity
    • Valutare la performance della PET/TC con 18F-FACBC rispetto ai fattori prognostici clinici di malattia (ad esempio valore del PSA, Gleason Score, stadio del tumore, risultati della PET/TC con Colina).
    • Calcolare sensibilità e specificità della 18F-FACBC PET/TC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects with biopsy-proven adenocarcinoma of the prostate
    2. Moderate- to high risk prostate cancer as defined by:
    -Moderate risk: T2b-T2c or Gleason score 7 or PSA 10-20 ng/mL;
    -High risk: T3a or Gleason score 8-10 or PSA > 20 ng/mL.
    3. Staging according to conventional preoperative workup tests (digital rectal examination, transrectal ultrasound, biopsy, likelihood of lymph node metastasis with clinical nomograms, Choline PET/CT)
    4. Choline PET/CT negative for bone metastases
    5. Surgical plan: prostatectomy with limited or extended lymph node dissection within 40 days from the imaging
    6. Age≥18
    1. Maschio maggiorenne affetto da cancro della prostata istologicamente confermato.
    2. Cancro della prostata a classe di rischio da moderato ad alto così definito:
    • Rischio moderato: T2b-T2c o GS 7 o PSA 10-20ng/ml;
    • Rischio alto: T3a o GS 8-10 o PSA>20 ng/ml
    3. Esami di stadiazione preoperatoria eseguiti come previsto nell’ambito del normale percorso assistenziale (ad esempio: esplorazione rettale, ecografia trans rettale, biopsia, calcolo di probabilità di metastasi linfonodali attraverso i nomogrammi clinici, PET/TC con Colina)
    4. PET/TC con Colina negativa per metastasi ossee
    5. Strategia chirurgica di prostatectomia radicale con dissezione linfonodale programmata entro 40 giorni dall’esecuzione dell’imaging
    6. Ottenimento del consenso informato
    E.4Principal exclusion criteria
    1. Inability to undergo 18F-FACBC PET/CT scanning for any reason.
    2. Prior invasive malignancy (except basal cell carcinoma) unless disease-free for a minimum of 3 years
    3. Severe acute co-morbidity
    4. Specific preoperative therapy (hormonal treatment, chemotherapy, radiotherapy
    1. Impossibilità di sottoporsi all’esame PET/TC con 18F-FACBC per qualsiasi ragione.
    2. Pregressa storia di altri tumori (ad eccezione del carcinoma a cellule basali), a meno che non sia dimostrato periodo libero da malattia per un minimo di 3 anni.
    3. Severa co-morbidità acuta.
    4. Terapia specifica pre-operatoria (terapia ormonale, chemioterapia, radioterapia)
    E.5 End points
    E.5.1Primary end point(s)
     To evaluate the accuracy of 18F-FACBC PET/CT for preoperative lymph node staging in moderate to high risk prostate cancer patients who are already scheduled for prostatectomy and pelvic lymph node dissection
    • Valutare l’accuratezza diagnostica della PET/TC con 18F-FACBC nella stadiazione linfonodale preoperatoria di pazienti affetti da carcinoma della prostata a rischio moderato-alto, già in nota operatoria per prostatectomia radicale e linfoadenectomia pelvica
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 months
    2 mesi
    E.5.2Secondary end point(s)
    • To evaluate 18F-FACBC performance respect to standard clinical predictive factors of disease (e.g. age, psa, gleason score,tumor stage, choline PET/CT results).
    • To calculate 18F-FACBC sensitivity and specificity
    • Valutare la performance della PET/TC con 18F-FACBC rispetto ai fattori prognostici clinici di malattia (ad esempio valore del PSA, Gleason Score, stadio del tumore, risultati della PET/TC con Colina).
    • Calcolare sensibilità e specificità della 18F-FACBC PET/TC
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 months
    2 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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The 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 years
    E.8.9.1In the Member State concerned months19
    E.8.9.1In the Member State concerned days
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state110
    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)
    Normal clinical practice
    Normale percorso assistenziale
    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 Decision2014-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-02
    P. End of Trial
    P.End of Trial StatusOngoing
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