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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-004397-99
    Sponsor's Protocol Code Number:MBCC28040
    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:2014-02-25
    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 number2013-004397-99
    A.3Full title of the trial
    A Phase III Clinical Trial to evidence the safety and efficacy of the radio-drug 18f-Fluorocholine (18F-FCH), using Positron Emission Tomography (PET) for the diagnosis of the prostate carcinoma in patients with biochemical relapse.
    Ensayo clínico fase III de evidencia de eficacia y seguridad clínicas del radiofármaco [18F]-fluorocolina (18F-FCH), utilizando tomografía por emisión de positrones (PET), para el diagnóstico de carcinoma de próstata en pacientes con recidiva bioquímica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III Clinical Trial to evidence the safety and efficacy of the radio-drug 18f-Fluorocholine (18F-FCH), using PET for the diagnosis of the prostate carcinoma in patients with biochemical relapse.
    Ensayo clínico fase III de evidencia de eficacia y seguridad clínicas de 18F-fluorocolina utilizando PET para el diagnóstico de cáncer de próstata en pacientes con recidiva bioquímica
    A.4.1Sponsor's protocol code numberMBCC28040
    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 SponsorInstituto Tecnológico PET, S.A.U. (ITP)
    B.1.3.4CountrySpain
    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 supportInstituto Tecnológico PET, S.A.U. (ITP)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto Tecnológico PET, S.A.U. (ITP)
    B.5.2Functional name of contact pointEmilio Viñas Navarro
    B.5.3 Address:
    B.5.3.1Street AddressC/ Manuel Bartolomé Cossío nº 10
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number34915344896135
    B.5.5Fax number34915530845
    B.5.6E-mailevinas@petmadrid.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 name(18F) Fluorometilcolina
    D.3.2Product code 18f-FCH
    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 INN18F-FCH
    D.3.9.2Current sponsor code18F-FCH
    D.3.9.3Other descriptive name18F-FLUOROMETHYLCHOLINE
    D.3.9.4EV Substance CodeSUB30954
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/kg megabecquerel(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.0
    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 Carcinoma in patients with biochemical relapse.
    Carcinoma de próstata en pacientes con recidiva bioquímica
    E.1.1.1Medical condition in easily understood language
    Relapse of prostate cancer
    Reaparición del cáncer de próstata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 diagnostic efficiency in terms of the classification probabilities (sensitivity and specificity) of the PET CT with 18F-FCH in demonstrating the recurrence of prostate cancer in patients with biochemical relapse who have undergone radical primary treatment, using as reference standard the histology of the lesions (in some cases the confirmation of the diagnosis can be made with clinical follow-up)
    Evaluar el rendimiento diagnóstico, en términos de probabilidades de clasificación (sensibilidad y especificidad) de la PET TC con 18F-FCH en la demostración de la recidiva del cáncer de próstata en pacientes con recidiva bioquímica que han sido sometidos a tratamiento primario radical, empleando como patrón de referencia la histología de las lesiones (en algunos casos la confirmación del diagnóstico se podrá realizar con seguimiento clínico)
    E.2.2Secondary objectives of the trial
    1-Diagnostic efficiency of the PET CT with 18F-FCH. In a complementary manner, the Diagnostic efficiency using each lesion as analysis unit.2- To evaluate the impact on the diagnostic process of prostate cancer recurrence 3- To evaluate the diagnostic efficiency of the TC with contrast- (intravenous and oral) as an isolated test 4- To evaluate the diagnostic efficiency of the MR as an isolated test 5- To evaluate the diagnostic efficiency of the bone scan (OG)as an isolated test 6- To evaluate the diagnostic efficiency of the PET in the utility of the test terms 7- Evaluation of the influence of the diagnostic performance of PET-TC with 18F-FCH of the serum PSA parameters, doubling time, PSA velocity, radical primary treatment, reference standard and clinical situation. To evaluate the detection threshold of PET-CT with 18F-FCH. 8- To calculate the correlation values. To evaluate the SUVmax positivity threshold.9- Safety Evaluation of PET-TC with 18F-FCH
    1- Rendimiento diagnóstico con PET con 18F-FCH. De forma complementaria rendimiento diagnóstico empleando cada lesión como unidad de análisis 2- Evaluar el impacto sobre el proceso diagnóstico de la recidiva del cáncer de próstata 3- Evaluar el rendimiento diagnóstico de la TC con contraste (intravenoso y oral) como prueba aislada 4- Evaluar el rendimiento diagnóstico de la RM como prueba aislada 5- Evaluar el rendimiento diagnóstico de la gammagrafía ósea (GO) como prueba aislada 6- Evaluar el rendimiento diagnóstico de la PET en términos de utilidad de la prueba. 7-Evaluación de la influencia sobre el rendimiento diagnóstico de la PET-TC con 18F-FCH de los parámetros PSA sérico, tiempo de duplicación, velocidad del PSA, tratamiento primario radical, patrón de referencia y situación clínica. Evaluar el umbral de detección de la PET-TC con 18F-FCH. 8- Calcular valores de correlación. Evaluar el umbral de positividad del SUVmax. 9- Evaluación de la seguridad de la PET-TC con 18F-FCH
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male.2.Age≥18 years.3. Patients with biochemical relapse of Prostate Carcinoma who have reached any of the following serum PSA levels after a previous primary radical treatment: In patient treated with radical prostatectomy must have passed at least 3 months from the urgery and PSA value will be: (a) higher than 1.0 ng / mL or (b) higher than 0.4 ng / mL in cases of doubling time of less than 6 months. In the patients treated with external radiotherapy or brachytherapy, PSA elevation will be: (c) higher than 2 ng / mL over the nadir. 4. That he has been made an image test (CT with contrast (intravenous and oral), MRI and / or bone scan) up to a maximum of 15 days before the PET-TC with 18F-FCH, or it is scheduled to perform this test in a maximum of 15 days after the PET-TC with 18F-FCH. Contrast CT (intravenous and oral) data are also valid if they are performed with the PET scan with 18F-FCH. 5. Capability to undergo to the explorations. 6. With the signed and dated Informed consent, accepting the participation in the study.
    1.Varón. 2.Edad ?18 años. 3.Pacientes con recidiva bioquímica de carcinoma de próstata que han alcanzado alguno de los siguientes niveles de PSA en suero tras tratamiento primario radical previo: En los pacientes tratados con prostatectomía radical deben haber transcurrido al menos 3 meses desde la cirugía y el valor del PSA será: (a) mayor de 1,0 ng/mL o (b) mayor de 0,4 ng/mL en casos de tiempo de duplicación menor a 6 meses. En los pacientes tratados con radioterapia externa o braquiterapia la elevación del PSA será: (c) mayor de 2 ng/mL por encima del nadir. 4.Que se le haya realizado una prueba de imagen (TC con contraste (intravenoso y oral), una RMN y/o una gammagrafía ósea) como máximo 15 días antes de la PET-TC con 18F-FCH, o que esté previsto realizar esta prueba en un máximo de 15 días después de la PET-TC con 18F-FCH. También son válidos los datos de TC con contraste (intravenoso y oral) si se realizan junto con la prueba PET con 18F-FCH. 5.Capacitación para someterse a las exploraciones. 6.Con Consentimiento Informado firmado y fechado, aceptando la participación en el estudio
    E.4Principal exclusion criteria
    1.- Surgery performed on the month previous to the PET-CT with 18F-FCH performance. 2. - Prostate biopsy performed on the month before the PET-CT with 18F-FCH test. 3. - Diagnosis of a second primary neoplasia. 4.- Concomitant medication, nutritional supplements or dietetic products containing choline. 5.- Previous known allergic reaction to any of the formulation components of the 18F-FCH or to the contrasts (intravenous or oral) used for the CT. 6.- Life expectancy of less than 6 months. 7.- Lack of cooperation of the patient to participate (following the investigator criteria). 8.- Participation in other clinical trial during the month previous to the inclusion.
    1.Cirugía en el mes previo a la exploración con PET-TC con 18F-FCH. 2.Biopsia prostática en el mes previo a la exploración con PET-TC con 18F-FCH. 3.Diagnóstico de segunda neoplasia primaria. 4.Medicación concomitante, suplementos nutricionales o productos dietéticos que contenga colina. 5.Reacción alérgica previa conocida a un componente de la formulación con 18F-FCH o con los contrastes (intravenoso y oral) utilizados en la TC. 6.Expectativa de vida inferior a seis meses. 7.Falta de colaboración del paciente para la participación (según criterio del investigador). 8.Participación en otro ensayo clínico durante el mes previo a la inclusión
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the diagnostic efficiency of the PET-CT on an individual level
    Evaluar el rendimiento diagnóstico de la PET-TC a nivel de individuo
    E.5.1.1Timepoint(s) of evaluation of this end point
    The corresponding specialist will consider the test positive if there is evidence of abnormal catchment in any location under evaluation. Likewise, the reference compare will be positive if there is evidence of a clinical relapse in any location.
    All imaging tests evaluated in the study objectives will be performed within the period of 15 days before or after the PET-TC with 18f-FCH has been performed.
    Se considerará que la prueba es positiva si se evidencia captación anormal en cualquier localización valorada por los especialistas correspondientes. Análogamente, se considerará que el patrón de referencia es positivo si se evidencia la presencia de recidiva clínica en cualquier localización.
    Todas las pruebas de imagen evaluadas en los objetivos del estudio se realizarán dentro de un margen de 15 días antes o después de la PET-TC con 18F-FCH.
    E.5.2Secondary end point(s)
    1.-Demonstration, in separate, of the clinical relapses, local-regional and at distance. 2. - Evaluate the impact of the PET-CT over the reasonable diagnostic. 3. - Evaluate the secondary objectives related to the accuracy of the diagnostic with other imaging technics (CT with contrast, MRI and bone gamagraphy). 4. - Evaluate the influence of several factors over the efficiency of the diagnostic with PET-CT. 5.- Complete empiric estimations for the ROC curve. 6.- Analyze the safety of the radio tracer.
    1.-Demostración por separado de la recidiva clínica loco-regional y a distancia. 2.- Evaluar el impacto de la PET-TC sobre el razonamiento diagnóstico 3.- Evaluar los objetivos secundarios relacionados con la precisión diagnóstica de otras técnicas de imagen (TC con contraste, resonancia magnética y gammagrafía ósea). 4.- Evaluar la influencia de varios factores sobre el rendimiento diagnóstico de la PET-TC. 5.- Construir estimaciones empíricas de la curva ROC 6.- Analizar la seguridad del radiotrazador
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the performance of the imaging test. During the following 24 hours to the performance of the image test. During each patient's participation in the study (except those occurring in the course of the image test or within the following 24 hours)
    Durante la realización de la prueba de imagen. Durante las 24 horas siguientes a la realización de la prueba de imagen. Durante la participación de cada paciente en el estudio (excepto las que se produzcan durante la realización de la prueba de imagen o en las siguientes 24 horas)
    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 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 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 concerned8
    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
    Ultima visita del último paciente
    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 months11
    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.1.1.1In 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: 53
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with biochemistry relapse
    Pacientes con recidiva bioquimica
    F.4 Planned number of subjects to be included
    F.4.1In the member state107
    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)
    None
    Ninguno
    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 Decision2014-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-30
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