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    The EU Clinical Trials Register currently displays   37736   clinical trials with a EudraCT protocol, of which   6184   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-002203-32
    Sponsor's Protocol Code Number:XRP6976J/3501
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-19
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2004-002203-32
    A.3Full title of the trial
    A Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal Therapy (ELIGARD®- leuprolide acetate) in Combination with TAXOTERE® (docetaxel) Administered Every Three Weeks Versus Hormonal Therapy Alone Versus Deferred Therapy Followed by the Same Therapeutic Options in Patients with Prostate Cancer at High Risk of Relapse After Radical Prostatectomy
    A.4.1Sponsor's protocol code numberXRP6976J/3501
    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 Sponsorsanofi-aventis 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 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 22,5 mg powder and solvent for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameEligard 22.5 mg
    D.3.4Pharmaceutical form Powder and solvent for solution 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 INNLeuprorelin acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22.5
    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 Information not present in EudraCT
    D.IMP: 2
    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 Taxotere
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTaxotere
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDocetaxel
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Information not present in EudraCT
    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 Cancer at High Risk of Relapse After Radical Prostatectomy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to compare progression-free survival (PSA progression after systemic treatment, radiologically or histologically documented progression after systemic treatment or death from any cause, whichever occurs first), using a 2x2 factorial design among treatment groups as follows:
    • Immediate treatment following prostatectomy [Treatment Arms: I(CHT), I(HT)] versus deferred treatment at the time of relapse [Treatment Arms: D(CHT), D(HT)]
    • TAXOTERE® q3w plus ELIGARD® (leuprolide acetate) [Treatment Arms: I(CHT), D(CHT)] versus ELIGARD® alone [Treatment Arms: I(HT), D(HT)]
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    • To compare the 5-year overall, cancer-specific and metastasis-free survival (metastasis-free survival based on time to clinical evidence of metastasis evidenced by physical exam or radiologically on bone scan or CT scan) after systemic treatment between the groups defined as follows:

    - Immediate treatment following prostatectomy [Treatment Arms: I(CHT), I(HT)] versus deferred treatment [Treatment Arms: D(CHT), D(HT)]
    - TAXOTERE® q3w plus ELIGARD® [Treatment Arms: I(CHT), D(CHT)] versus ELIGARD® alone [Treatment Arms: I (HT), D (HT)]
    • To compare the safety and tolerability between TAXOTERE® in combination with ELIGARD® and ELIGARD® alone.
    • To evaluate quality of life as measured by the FACT-P questionnaire.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients meeting all of the following criteria will be considered for enrollment into the study:
    1- Pathologically confirmed adenocarcinoma of the prostate based on central pathology review. All other variants are excluded
    2- Randomization should occur less than 120 days after prostatectomy AND lymphadenectomy. Patients who didn't undergo lymphadenectomy may be considered for randomization only if they are evaluated at high-risk according to Kattan nomogram (Instructions for Radical Prostatectomy, Appendix H)
    3- A predicted probability of 5-year freedom from progression ≤ 60%, as determined by the postoperative nomogram developed by M. Kattan. This probability will be assessed using data from central review of the prostatectomy specimen.
    4- Bone-scan without evidence of metastasis (within 6 months of randomization)
    5- Chest x-ray without evidence of metastasis (within 6 months of randomization)
    6- Abdominal CT Scan without evidence of metastasis (within 6 months of randomization)
    7- Age ≥18 years
    8- ECOG performance status ≤ 1 (Appendix A)
    9- Hematology evaluation within 2 weeks prior to randomization:
    a. Neutrophils ≥ 2,000/mm3
    b. Hemoglobin ≥ 10 g/dL
    c. Platelets ≥ 100,000/mm3
    10- Hepatic and renal function evaluation within 2 weeks prior to randomization:
    a. Serum creatinine ≤1.5 × UNL for the institution. If serum creatinine is > 1.5 × UNL, calculated creatinine clearance (should be ≥ 60ml/minute).
    b. Total serum bilirubin ≤ UNL for the institution. Patients with Gilbert’s syndrome may be eligible if indirect serum bilirubin levels at the time of randomization and, at least 6 month prior to randomization, confirm this condition (i.e. elevated indirect serum bilirubin).
    c. SGOT and/or SGPT ≤1.5 × institutional UNL if alkaline phosphatase is ≤ UNL OR
    d. alkaline phosphatase ≤ 5 × UNL if SGOT and SGPT are ≤ UNL
    11- PSA evaluation within 9 months prior to prostatectomy. However, a 120-day timeframe is recommended
    12- Post operative PSA necessary for eligibility is defined as a level of ≤ 0.2 ng/mL using a standard assay at least 30 days after radical prostatectomy and within 7 days prior to randomization. Note that randomization should occur within 120 days after radical prostatectomy (see inclusion criterion 2).
    13- Serum testosterone ≥ 150 ng/dL within 6 months prior to randomization.
    14- Life expectancy ≥ 5 years
    15- Signed, written informed consent prior to randomization.
    16- Patients must be accessible for treatment and follow-up. Patients randomized in this trial must be treated and followed at the participating center.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1- Prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or any other anticancer therapy.
    2- Prior radiation therapy for prostate cancer.
    3- Patients who received, are receiving, or scheduled to receive post-operative radiotherapy.
    4- Patients taking alternative therapies for cancer must stop taking these therapies prior to randomization. Alternative therapies are not allowed during the treatment or follow-up portions of the study. This includes (but is not limited to) alternative therapies such as:
    a. PC-SPES (all types)
    b. 5-alpha reductase inhibitors
    5- Bisphosphonates are to be stopped prior to randomization and are not allowed during the study.
    6- Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (≤ 20 mg methylprednisolone per day or equivalent).
    7- History of a malignancy other than prostate cancer. Exceptions to these criteria include:
    a. patients with adequately treated non-melanoma skin cancers, and
    b. patients with a history of another malignancy that was curatively treated (including patients with superficial bladder cancer) and who have not had evidence of disease for a minimum of 5 years.
    8- Peripheral neuropathy ≥ Grade 2.
    9- ECG with significant abnormalities (as determined by the investigator) within 90 days prior to randomization.
    10- Psychological, familial, sociological, or geographical conditions, which do not permit treatment and/or medical follow-up, required to comply with the study protocol.
    11- Patients who are medically unstable, including but not limited to active infection, acute hepatitis, gastrointestinal bleeding, uncontrolled cardiac arrhythmias, interstitial lung disease, inflammatory bowel disease, uncontrolled angina, uncontrolled hypercalcemia, uncompensated congestive heart failure, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome.
    12- Patients with history of hypersensitivity to polysorbate 80.
    13- Patients with a known history of viral hepatitis (B, C)
    E.5 End points
    E.5.1Primary end point(s)
    The primary analysis variable is progression-free survival (PFS) after protocol-defined systemic therapy.
    PFS is defined as the interval from the date of surgery to the date of PSA progression after systemic treatment, date of radiologically or histologically documented progression after systemic treatment or date of death from any cause, whichever occurs first.
    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 Information not present in EudraCT
    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 Yes
    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) Yes
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA84
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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 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 state0
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 235
    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)
    No specific recommendation, treatment/care according to investigator's practice
    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 Decision2005-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-22
    P. End of Trial
    P.End of Trial StatusCompleted
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