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    Summary
    EudraCT Number:2012-000566-38
    Sponsor's Protocol Code Number:GETUG-AFU_23_/_UC-0160/1202
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2015-10-05
    Trial 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 number2012-000566-38
    A.3Full title of the trial
    A randomized Phase III, factorial design, of cabazitaxel and pelvic radiotherapy in patients with localized prostate cancer and high-risk features of relapse.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    _
    A.3.2Name or abbreviated title of the trial where available
    PEACE 2
    A.4.1Sponsor's protocol code numberGETUG-AFU_23_/_UC-0160/1202
    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 SponsorUNICANCER
    B.1.3.4CountryFrance
    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 supportSANOFI
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportIPSEN
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address101, rue de Tolbiac
    B.5.3.2Town/ cityParis cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number33173 77 55 43
    B.5.5Fax number33185 34 33 79
    B.5.6E-mailpeace2@unicancer.fr
    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 JEVTANA
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-aventis groupe
    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.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    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 INNCABAZITAXEL
    D.3.9.1CAS number 183133-96-2
    D.3.9.4EV Substance CodeSUB31282
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 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 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
    Patients with localized prostate cancer and high-risk features of relapse.
    E.1.1.1Medical condition in easily understood language
    Prostate cancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 the effect of neoadjuvant cabazitaxel and pelvic radiotherapy in combination with ADT-radiotherapy on clinical progression-free survival in patients with high-risk localized prostate cancer (with a stringent selection of patients with at least 2 high-risk features), in a 2 by 2 factorial trial.
    E.2.2Secondary objectives of the trial
    - Prostate-specific antigen response at 3 months
    - Biochemical progression-free survival
    - Metastases-free survival
    - Local relapse-free survival
    - Overall survival
    - Prostate cancer-specific survival
    - Acute toxicity
    - Impact of treatment on serum testosterone
    - Long-term toxicity (including toxicity related to radiotherapy)
    - Predictive biomarkers of treatment efficacy
    - Quality of life
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Predictive biomarkers of treatment efficacy.
    E.3Principal inclusion criteria
    1) Any T histologically confirmed adenocarcinoma of the prostate
    2) No clinically or radiologically suspected metastases, including no enlarged pelvic lymph nodes (> 1 cm in small diameter)
    3) Gleason score ≥ 6
    4) Meets at least 2 of the following criteria for high-risk:
    - Gleason score ≥ 8
    - T3 or T4 disease (T3 defined by MRI is acceptable)
    - Prostate-specific antigen equal or greater than 20 ng/mL
    5) No prior treatment for prostate cancer except lymph node dissection (patients with pN- and pN+ disease can be accrued) or ADT (started up to 6 weeks before randomization).
    6) 18 years ≤ Age≤ 75 years
    7) ECOG 0-1 performance status
    8) Expected life expectancy of more than 10 years
    9) Absolute neutrophil count ≥ 1.5 x 10^9/L
    10) Platelets ≥ 100 x 10^9/L
    11) Hb ≥ 9.0 g/dL
    12) Hepatic function: serum bilirubin ≤ 1 ULN (except in case of Gilbert's syndrome) ; AST and ALT ≤ 2.5 x ULN
    13) Renal function (creatinine clearance using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group) ≥ 60 mL/min).
    14) Potentially reproductive patients must agree to use an effective contraceptive method while on treatment and for 6 months after the final dose of investigational product.
    15) Patients must be affiliated to a Social Security System or should fulfill the country legislation for clinical trials.
    16) Patients who have received the information sheet and signed the informed consent form.
    17) Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
    E.4Principal exclusion criteria
    1) Patients with other known concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as:
    a- infection,
    b- cardiac disease such as uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, LVEF > grade 2,
    c- uncontrolled diabetes mellitus,
    d- current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment),
    e- renal disease,
    f- active GI tract ulceration, malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled ulcerative colitis are also excluded,
    g- known severely impaired lung function (spirometry and DLCO 70% or less of normal and O2 saturation of 88% or less at rest on room air).
    2) Other prior malignancy within the last 5 years, except basal cell skin cancer
    3) Physical or psychological condition that would preclude study compliance
    4) Hypersensitivity to cabazitaxel (hypersensitivity reaction ≥grade 3), to other taxanes, or to any excipients of the formulation including polysorbate 80
    5) Patients with significantly altered mental status prohibiting the understanding of the study or with 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.
    6) Patients who received any other investigational drugs within the 30 days prior to the start of cabazitaxel.
    7) Previous pelvic irradiation that make prostatic irradiation impossible
    8) Severe GI disorders precluding pelvic irradiation
    9) Patients already included in another therapeutic trial involving an experimental drug
    10) Individual deprived of liberty or placed under the authority of a tutor.
    11) Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (see Appendix 6). A one week wash-out period is necessary for patients who are already on these treatments.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical Progression-Free Survival (cPFS) at 6 years, the event being defined by a metastatic relapse, a local progression or the patient death (all causes).
    A metastatic relapse will be defined by the appearance of undebatable metastases on imaging (mainly bone scan and CT-Scan).
    A local relapse will be defined as an indisputable local progression of prostate cancer by clinical examination or imaging. Pathological confirmation of the local progression is highly recommended.
    E.5.1.1Timepoint(s) of evaluation of this end point
    _
    E.5.2Secondary end point(s)
    - The prostate-specific antigen response at 3 months will be defined as a serum PSA value (≤ 0.2 ng/mL)
    - The biochemical progression-free survival is defined as the time from randomization to the date of PSA relapse (evaluated according to Phoenix criteria i.e. nadir + 2 ng/mL) or death.
    - The metastases-free survival is defined as the time from randomization to the date of the appearance of the metastases on imaging (mainly bone scan and CT-scan) or death.
    - The local relapse-free survival is defined as the time from randomization to the date of the appearance of the first local relapse or death.
    - The overall survival will be calculated from the date of randomization to the date of death from any cause or date of the last follow-up.
    - The prostate cancer-specific survival will be calculated from the date of randomization to the date of the death due to prostate cancer
    - The acute toxicity (i.e. during the treatment period), will be evaluated according to the NCI-CTC v4.0 criteria
    - The impact of treatment on serum testosterone will be evaluated at baseline, 6 months then yearly.
    - The long-term toxicity (potency, cardiac, hot flashes and late toxicity related to radiotherapy or chemotherapy) will be evaluated at 1 year, 2 years and 5 years. The toxicity related to the radiotherapy will be assessed using NCI-CTC v4.0 criteria.
    - The predictive biomarkers of treatment efficacy will be assessed on archival biopsy specimens
    - The quality of life will be evaluated with the QLQ –C30 and PR25 questionnaires at baseline, 6 months then yearly up to 10 years after the randomization date.
    E.5.2.1Timepoint(s) of evaluation of this end point
    _
    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
    Quality of life
    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 No
    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 four randomization arms will be compared / factorial design
    E.8.2.4Number of treatment arms in the trial4
    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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years28
    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 years28
    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: 524
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 524
    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 state1048
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1048
    F.4.2.2In the whole clinical trial 1048
    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
    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 Decision2015-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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