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    Summary
    EudraCT Number:2006-002772-17
    Sponsor's Protocol Code Number:22043-30041
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-12-04
    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 number2006-002772-17
    A.3Full title of the trial
    Radioterapia externa postoperatoria combinada con tratamiento hormonal adyuvante y concomitante frente a la radioterapia externa postoperatoria como tratamiento único en el carcinoma de próstata estadio pT3a-b R0-1 N0M0 / pT2R1 N0M0 y con puntuación de Gleason 5-10. Estudio fase III.

    (Post-operative external radiotherapy combined with concomitant and adjuvant hormonal treatment versus post-operative external radiotherapy alone in pathological stage pT3a-b R0-1 N0M0 / pT2R1 N0M0, Gleason score 5-10 prostatic carcinoma. A Phase III study)
    A.4.1Sponsor's protocol code number22043-30041
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEuropean Organisation for Research and Treatment of Cancer
    B.1.3.4CountryBelgium
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name ELIGARD SEMESTRAL 45 mg polvo y disolvente para solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEUPRORELINA ACETATO
    D.3.9.1CAS number 74381-53-6
    D.3.9.3Other descriptive nameLEUPRORELINA ACETATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeGnRH agonista (gonadotropin releasing hormone agonist)
    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
    Un carcinoma de próstata estadio pT3a-b R0-1 N0M0 / pT2R1 N0M0 y con puntuación de Gleason 5-10.

    (Prostatic carcinoma with pathological stage pT3a-b R0-1 N0M0 / pT2R1 N0M0, Gleason score 5-10)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036955
    E.1.2Term Prostatic carcinoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigar el potencial beneficio de un tratamiento adyuvante combinado de tratamiento corto de privación androgénica con radioterapia (RT) post-operatoria comparado con RT sola, para mejorar el intervalo libre de progresión bioquímica en pacientes que han sido tratados con prostatectomía radical con estadios cT1-2-3a N0M0 por cáncer de próstata con PSA basal < 5 veces el valor superior normal y que en el estadio patológico sean pT2 R1/pT3a-b R0-1 N0 M0, Gleason 5-10 y PSA post-operatorio indetectable

    (To investigate the potential benefit, in terms of biochemical progression free survival, of a combined adjuvant treatment consisting of short term androgen suppression in addition to postoperative RT in comparison to post-operative RT alone.)
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Pacientes con estadio clínico cT1-2-3 a N0 M0 con cáncer de próstata (UICC TNM 2002) comprobado después de un estadiaje que incluya exploración física, radiografía de tórax, gammagrafía ósea, TC o RM abdomino-pélvica.
    -PSA preoperatorio < de multiplicar por 5 el límite superior normal
    -Prostatectomía: todas las técnicas permitidas ( retropúbica, laparoscópica o perineal)
    Tras la prostatectomía:
    -Gleason 5-10
    -Estadio pT2R1 (margen positivo quirúrgico con una sección tumoral como mínimo de 2 mm) o pT3a-b ( márgenes negativos o positivos)
    -Ganglios negativos (pN0) por muestra ganglionar o por linfadenectomía. Un estado ganglionar desconocido (pNx) no está permitido a no ser que el paciente tenga un cT1 con PSA menor de 10 y Gleason menor de 7 con biopsias positivas en menos del 50%, con un total de biopsias de cómo mínimo 12.
    -PSA pos-op no detectable en los tres primeros meses tras cirugía
    -Edad < 80 años
    -PS OMS 0-1
    -Hemograma normal dentro de las dos semanas previas a la aleatorización: Hemoglobina > 110 g/l, leucocitos > 3x10•9/l, plaquetas > 100 x 10•9/l
    -Consentimiento informado por escrito antes de la aleatorización


    (•Patients with clinical stage cT1-2-3a N0M0 prostate cancer (UICC TNM 2002) assessed after a preoperative work-up including physical examination, chest X ray, bone scan, CT-scan or MRI of the entire pelvis and abdomen.
    •Pre-operative PSA &#8804; 5 x upper limit of normal range.
    •Presenting after radical prostatectomy (all techniques allowed: retropubic, laparoscopic or perineal) with
    •Gleason score 5-10.
    •Pathologic stage pT2R1 (positive surgical margins with at least a tumor trans-section higher than 2 mm) or pT3a-b (irrespective of margin status).
    •Negative lymph node (LN) status (pN0) by LN sampling or LN dissection. Unknown pathological LN status (pNx, i.e., omission of LN sampling or LN dissection) is not allowed except for patients classified as cT1c with baseline PSA < 10ng/ml and Gleason score < 7 and positive core biopsies < 50%, provided the total number of random biopsies is at least 12.
    •Undetectable post-operative PSA (PSA is below the detection level of the laboratory) within 3 months of surgery.
    •Age &#8804; 80 years.
    •WHO performance status 0-1.
    •Normal organ functions as shown by all of the following (measured within 2 weeks prior to randomization): hemoglobin &#8805; 110 g/l, WBC &#8805;3 x 109/l, platelet count &#8805; 100 x 109/l.

    •Before randomization, written informed consent must be given by the patient, according to ICH/GCP, and national/local regulations.)
    E.4Principal exclusion criteria
    -RT previa ò orquiectomía previa
    -Quimioterapia previa en los últimos 5 años
    -Tratamiento hormonal previo excepto neoadyuvante < 3 meses
    -Otras neoplasias excepto carcinoma basocelular de la piel u otras sin evidencia de enfermedad en los últimos 5 años.
    -Trastorno psico social, familiar, sicológico o geográfico que impidan cumplir bien el protocolo o el seguimiento.

    (•Prior pelvic irradiation, prior bilateral orchiectomy.
    •Prior chemotherapy within the 5 years prior to randomization.
    •Prior hormonal treatment except neoadjuvant and lasting &#8804;3 months.
    •Other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease free for at least 5 years.
    •Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.)
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia sin progresión bioquímica

    (The primary trial endpoint is biochemical progression-free survival)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Calidad de Vida (Quality of Life); Investigación traslacional (Translational Research)
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Radioterapia solà (radiotherapy alone)
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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
    c.f. protocolo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 580
    F.4.2.2In the whole clinical trial 600
    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 Decision2010-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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