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    Summary
    EudraCT Number:2005-001602-76
    Sponsor's Protocol Code Number:AP 40/04
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-01-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-001602-76
    A.3Full title of the trial
    Phase III clinical trial comparing treatments of hormone-refractory prostate cancer (HRPC) with Docetaxel: continuous treatment vs. intermittent repetition of treatment after progression.

    A.3.2Name or abbreviated title of the trial where available
    PRINCE
    A.4.1Sponsor's protocol code numberAP 40/04
    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 SponsorCharité - Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 Taxotere 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma S.A.
    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 nameTaxotere 20 mg
    D.3.2Product code Docetaxel
    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.3.9.2Current sponsor codeDocetaxel
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    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 80 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma S.A.
    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 nameTaxotere 80 mg
    D.3.2Product code Docetaxel
    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.3.9.2Current sponsor codeDocetaxel
    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 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
    Treatment of hormone-refractory prostate cancer (HRPC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10062904
    E.1.2Term Hormone-refractory prostate cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective is the comparison between the continuous therapy and the intermittent therapy. It should be shown that the intermittent therapy is not inferior to the continuous therapy with regard to the primary criterion, i.e. the 1-year survival rate.
    E.2.2Secondary objectives of the trial
    Secondary objectives are comparisons between both treatment arms concerning

    - median survival-rate, median time-to-progression (TTP) and median time-to-failure (TTF). (The TTF is defined by the time until discontinuation of the treatment according to the study protocol. Within the intermittent arm, a progression occurring during the interval without therapy will not be included in the calculation of the TTP as an end point if the resumption of the treatment can prevent the occurrence of another progression "under treatment".)

    - the proportion of the patients suffering from adverse events > grade 2 according to CTCAE 3.0 which have been caused by the therapy.

    In addition, an exploratory comparison is planned between a weekly application and a three-weekly application with regard to all objectives of the trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • adenocarcinoma of the prostate confirmed by histology or cytology
    • metastasized adenocarcinoma of the prostate that is refractory to hormone
    treatment, ie, that does no longer respond to hormone therapy and/or the current
    treatment with estramustine
    • documented progression under the last therapy (definite PSA-increase that is
    confirmed by 2 subsequent measurements separated by at least 2 weeks, or
    increase of measurable lesions by at least 25% that is confirmed by radiological
    measurements)
    • previous hormone therapy
    • ECOG performance status <= 2 (Karnofsky index >= 60%)
    • adequate hematological, cardial and hepatic function defined by the following
    parameters:
    - absolute neutrophil count >= 2 x 109/l
    - thrombocytes >= 100 x 109/l
    - hemoglobin >=10 g/dl (6.2 mmol/l)
    - total serum bilirubin <= ULN
    - AST (SGOT) and ALT (SGPT) <= 1.5 x ULN
    - alkaline phosphatase <= 5 x ULN
    • life expectancy >= 12 weeks
    • written informed consent
    • age >= 18 years
    E.4Principal exclusion criteria
    • previous therapy with isotopes
    • previous chemotherapy (except estramustine)
    • radiotherapy in the 4 weeks prior to enrollment
    • previous radiotherapy if this concerned all lesions that are used for the evaluation
    of tumor response
    • previous radiotherapy if this concerned more than 25% of bone marrow
    • previous or concomitant neoplasm (except curatively treated in situ carcinoma and
    basal cell carcinomas of the skin as well as curatively treated neoplasms without
    recurrence in the 5 years prior to enrollment
    • previous or current cerebral metastases or leptomeningeal involvement
    • current peripheral neuropathy >= grade 2 (CTCAE 3.0)
    • renal inusufficiancy requiring dialysis
    • chronic diarrhea (now or in medical history)
    • other relevant concomitant diseases:
    a) congestive heart failure or uncontrolled angina pectoris, previous myocardial
    infarction within 6 months prior to enrollment, uncontrolled arterial
    hypertension or arrhythmias
    b) known significant neurological or psychiatric diseases including dementia and
    epileptic seizures
    c) active infections requiring intravenous administration of antibiotics
    d) ulcerations, not stable diabetes mellitus or other contraindications with regard
    to the administration of high doses of corticosteroids
    e) untreated vena-cava-syndrome
    f) known ascites or pericardial effusion
    g) known symptomatic pleural effusion that requires tapping
    • concomitant treatment with other anti-tumor therapies except LHRH-agonists in a
    constant dose (for at least 4 weeks prior to enrollment) which should be continued
    • participation in a clinical trial within 30 days prior to enrollment
    • being anable to complie with therapy and investigations
    E.5 End points
    E.5.1Primary end point(s)
    -Progression of the disease under treatment
    -Occurrence of adverse events which are not allowing the continution of the treatment according to the study protocol.
    -The patient's request
    -Other reasons for which a continuation of the treatment according to the study protocol would not be in the patient's best intest.
    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 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 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
    The continous therapy is compared to the intermittent therapy.
    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 concerned35
    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 Information not present in EudraCT
    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
    The end of the trial for each patient is defined by the final examination that will be performed 4 weeks after the last administration of Docetaxel.
    Within the scope of the optional follow-up, the date of the first progression (in case a progression date has not already been documented under therapy) and the date of death should be documented.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=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 state424
    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)
    Decisions about further treatment and therapy of patients after the end of the clinical trial are within the investigator's discretion. However, the date of death and date of progression should also be found out after the end of the clinical trial for each patient.
    The documentation of the state of health of the concerned patients within a follow-up is optional.
    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 Decision2005-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-08-03
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