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    Summary
    EudraCT Number:2005-004094-25
    Sponsor's Protocol Code Number:EGD-EC-003
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-01-05
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2005-004094-25
    A.3Full title of the trial
    A phase IIIb randomized study of intermittent versus continuous androgen deprivation therapy using ELIGARD 22.5 mg 3-month depot in subjects with relapsing and locally advanced prostate cancer who are responsive to such therapy
    A.3.2Name or abbreviated title of the trial where available
    ICELAND Study
    A.4.1Sponsor's protocol code numberEGD-EC-003
    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 SponsorAstellas Pharma Europe B.V.
    B.1.3.4CountryNetherlands
    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 Information not present in EudraCT
    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
    D.3.9.1CAS number 74381-53-6
    D.3.9.3Other descriptive nameleuprolide
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameCasodex 50 mg
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbicalutamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Histologically or cytologically confirmed adenocarcinoma of the prostate (PCa) meeting the following criteria:
    - Locally adv. (stage T3 or T4) PCa, N0 or N+, M0 with PSA >= 5 ng/ml, or
    - Relapsing PCa following radical prostatectomy for clinically localized PCa with a serum PSA of >= 0.4 ng/ml or,
    - Relapsing PCa following radiotherapy with a serum PSA of >= 1 ng/ml as compared to a previous reference value.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    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
    To assess prostate-specific antigen (PSA) and testosterone levels after continuous and intermittent androgen deprivation therapy and compare time to PSA progression.
    E.2.2Secondary objectives of the trial
    - To compare the overall survival of subjects with relapsing and locally advanced prostate cancer responsive to androgen-deprivation therapy (ADT) treated with intermittent vs. continuous ADT
    - To compare the effects of these treatment regimens on impotence, libido and vitality/fatigue as well as the physical and emotional well-being of these subjects
    - To compare general symptoms, role functioning, global perception of quality of life and social functioning of subjects treated with these regimens
    - To measure and compare bone turnover and exploratory biochemical/prognostic markers for disease progression in subjects treated with these regimens
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    At study entry (visit 1):
    1. Written informed consent has been obtained
    2. Male subjects aged >= 18 and <80 years old
    3. Histologically or cytologically confirmed adenocarcinoma of the prostate meeting the following criteria:
    - Locally advanced (stage T3 or T4) prostate cancer, N0 or N+, M0 with PSA >= 5 ng/ml, or
    - Relapsing prostate cancer following radical prostatectomy for clinically localized PCa with a serum PSA of >= 0.4 ng/ml that has risen on three successive occasions (values drawn at least 2 weeks apart) as compared to a previous reference value or,
    - Relapsing prostate cancer following radiotherapy with a serum PSA of >= 1 ng/ml that has risen on three successive occasions (values drawn at least 2 weeks apart) as compared to a previous reference value.
    4. Gleason score of >= 6
    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
    6. Life expectancy of at least 5 years

    At randomization (visit 4):
    7. Two successive decreasing serum PSA levels =< 1 ng/ml (at least 2 weeks apart) following 6 months of complete androgen suppression
    E.4Principal exclusion criteria
    At study entry (visit 1):
    1. Any suspected second primary tumors, including evidence from special stains (e.g. Prostatic acid phosphatase)
    2. Evidence of metastatic disease on bone scintigraphy or CT scan (bone scintigraphy or CT scan from within 6 months of V1 is acceptable)
    3. Other malignancy within the last 5 years except;
    - Adequately treated basal cell or squamous cell skin cancer
    - Adequately treated other superficial cancer
    4. Subjects with acute spinal cord compression, uni- or bilateral ureteric obstruction
    5. Any concurrent biological response modifier therapy
    6. Concurrent chemotherapy
    7. Less than 1 year since any prior neoadjuvant or adjuvant hormonal therapy for a duration of more than 4 months (single or combination therapy is allowed)
    8. Less than 6 months since prior 5-alpha reductase inhibitor treatment for prostate cancer and BPH.
    9. Other concurrent hormonal therapy (progesterone preparations for the treatment of subjects presenting with hot flushes are permitted)
    10. Any concurrent radiotherapy
    11. Testosterone at baseline =< 1.7 mM or 50 ng/dL
    12. Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine >150 mmol/L, AST or ALT > 2x upper limit of normal range (ULN), g-GT > 3x ULN and/or abnormal clinically significant serum total bilirubin (as assessed at visit 1 lab sampling)
    13. Subjects with hypersensitivity to GnRH or other GnRH analogues or leuprorelin acetate or any of the excipients of ELIGARD 22.5 mg
    14. Subjects with hypersensitivity to CASODEX 50 mg or any of the excipients.
    15. Any clinical condition, which in the opinion of the investigator would not allow safe completion of the study.
    16. Participation in any clinical study within 3 months, or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study.
    E.5 End points
    E.5.1Primary end point(s)
    Time to PSA progression, defined as ‘three consecutive increasing PSA values >= 4 ng/mL’ – modified ASTRO definition

    Based on the ASTRO definition, the date of PSA progression is the mid-point between the PSA nadir during or after the induction period and the first of three increasing PSA values >= 4 ng/mL. Time to progression is calculated from the date of randomization.

    The confirmatory PSA measurements (second & third) should be performed at the next routine study visits.
    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 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 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.8.6 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 Information not present in EudraCT
    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 years7
    E.8.9.2In all countries concerned by the trial months3
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 630
    F.4.2.2In the whole clinical trial 700
    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 Decision2006-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-16
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