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    Summary
    EudraCT Number:2009-014839-21
    Sponsor's Protocol Code Number:2008-CaP-FCH
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-11
    Trial results View 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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-014839-21
    A.3Full title of the trial
    Valor diagnóstico de la PET/TC con 18F-colina (PET/TC [18F]-FCH) para la detección de metástasis del cáncer de próstata.

    Diagnostic value of 18F-choline PET/CT for the detection of systemic prostate cancer disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Detección de metástasis del cáncer de próstata
    A.3.2Name or abbreviated title of the trial where available
    2008-CaP-FCH
    A.4.1Sponsor's protocol code number2008-CaP-FCH
    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 SponsorCIS bio international, member of IBA group
    B.1.3.4CountryFrance
    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 supportCIS bio international
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIBA Molecular Spain
    B.5.2Functional name of contact pointAsesor médico
    B.5.3 Address:
    B.5.3.1Street AddressAvda Dr Severo Ochoa 29
    B.5.3.2Town/ cityAlcobendas
    B.5.3.3Post code28100
    B.5.3.4CountrySpain
    B.5.4Telephone numberNANA+34 91 48419 89NA
    B.5.5Fax numberNANANANA
    B.5.6E-mailisabel.freile@iba-group.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 name18F-fluoromethylcholine
    D.3.2Product code 18F-FCH
    D.3.4Pharmaceutical form 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 INNNA
    D.3.9.2Current sponsor codeFCH
    D.3.9.3Other descriptive nameEthanaminium, N-18F-(fluoromethyl)-2hydroxy-N,N-Dimethyl ; (18F) fluoromethylcholine ; 18F-fluorocholine ; 18F-FCH.
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number225
    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
    Pacientes varones después de un primer diagnóstico de cáncer de próstata basado en estudio histopatológico (biopsia mediante punción del tumor primario)

    De novo patients with histologically confirmed prostate cancer
    E.1.1.1Medical condition in easily understood language
    Cáncer de próstata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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
    Sensitivity and specificity of [18F]-FCH PET/CT for systemic disease (i.e., lymph node metastases and/or organ metastases and/or bone metastases) on a body region basis.
    E.2.2Secondary objectives of the trial
    • Sensitivity and specificity of [18F]-FCH PET/CT for lymph node metastases using histopathology as the SOR and CT as a comparator (per lymph node area; only lymph nodes area with histopathological analysis).
    • Agreement rate between [18F]-FCH PET/CT and CT for organ metastases on a region basis. Discrepant cases will be documented by MRI. For lung metastases, discrepant results will be documented by a chest CT performed within 6 monthsafter [18F]-FCH PET/CT.
    • Agreement rate between [18F]-FCH PET/CT and bone scintigraphy with regard to bone metastases (on a body region basis). Discrepant cases will be documented by MRI.
    • Sensitivity and specificity of [18F]-FCH PET/CT for systemic disease (i.e., lymph node metastases and/or organ metastases and/or bone metastases) on a patient basis.
    • Agreement between [18F]-FCH PET/CT and pelvic MRI for the primary tumor.
    • Modification of tumor primary staging and patient management.
    • Safety of [18F]-FCH
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male
    2. Age > or = 18 years
    3. De novo patient with histologically confirmed prostate cancer and high risk disease according to D’AMICO criteria: stages > or = T2c and/or PSA > or = 20 ng/ml and/or Gleason score > or = 8, or Gleason score = 7 with either predominance of grade 4 or percentage of positive biopsy > 50%
    4. Patient who has already been imaged by contrast-enhanced thoraco-abdominal CT and bone scintigraphy
    5. Patient who is able to undergo all study procedures and who has signed a written informed consent form to participate in the study
    E.4Principal exclusion criteria
    1. Surgery within the last 4 weeks prior to the administration of [18F]-FCH
    2. History of other malignant tumor
    3. Previous radiation therapy
    4. Prostate biopsy within 4 weeks before [18F]-FCH PET/CT
    5. Concomitant medications containing choline
    6. Severe allergic reaction to any of the ingredients of the choline formulation
    7. Participation in another clinical study within one month prior to inclusion
    8. Uncooperative, in the investigator's opinion
    9. Linguistic or psychological inability to sign the informed consent form and/or take part in the study
    10. Having already participated in this clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    Sensitivity and specificity of [18F]-FCH PET/CT for primary staging of prostate cancer
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of the study through a blinded central read
    E.5.2Secondary end point(s)
    •Sensitivity and specificity of [18F]-FCH PET/CT for lymph node metastases using histopathology as the SOR and CT as a comparator (per lymph node area; only lymph nodes area with histopathological analysis). Quantification using SUV (quantitative uptake in lymph nodes) will be used.
    •Agreement rate between [18F]-FCH PET/CT and CT for organ metastases on a region basis. Discrepant cases will be documented by MRI (except for lung metastases). For lung metastases, discrepant results will be documented by a chest CT performed within 6 months after [18F]-FCH PET/CT.
    •Agreement rate between [18F]-FCH PET/CT and bone scintigraphy with regard to bone metastases (on a body region basis). Discrepant cases will be documented by MRI.
    •Sensitivity and specificity of [18F]-FCH PET/CT for systemic disease (i.e., lymph node metastases and/or organ metastases and/or bone metastases) on a patient basis.
    •Agreement rate between [18F]-FCH PET/CT and pelvic MRI (if available) for the primary tumor.
    •Modification of tumor primary staging and patient management.
    •Safety of [18F]-FCH
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of the study
    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 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 Yes
    E.8.1.7.1Other trial design description
    Blinded read session of the imaging results
    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
    CT scan and bone scintigraphy.
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 end of the trial will take place when the last patient undergoing the trial will have finished the follow up period. The follow up period may contain additional imaging tests (MRI or chest CT) which have to be done within 6 months after injection of the study product. The additional imaging tests concern patients with
    discrepant results between [18F]-FCH and CT or bone scintigraphy.
    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.1.1.1In 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    The study drug is for diagnostic purpose. Treatment and care are not modified.
    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 Decision2011-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-30
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