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    Summary
    EudraCT Number:2013-000674-30
    Sponsor's Protocol Code Number:2013-000674-30
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-05-17
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-000674-30
    A.3Full title of the trial
    Multicenter clinical trial, randomized phase II "window of opportunity" which aims to test the biological activity of abiraterone acetate administered as neoadjuvant therapy in patients with prostate cancer at high risk. (multicenter study).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter clinical trial, randomized phase II "window of opportunity" which aims to test the biological activity of abiraterone acetate administered as neoadjuvant therapy in patients with prostate cancer at high risk. (multicenter study).
    A.3.2Name or abbreviated title of the trial where available
    abiraterone neoadiuvante
    A.4.1Sponsor's protocol code number2013-000674-30
    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 SponsorAOU SAN LUIGI GONZAGA - SCDU ONCOLOGIA MEDICA
    B.1.3.4CountryItaly
    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 supportJANSSEN CILAG
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSCDU-ONCOLOGIA MEDICA - AOU SAN LUIGI GONZAGA
    B.5.2Functional name of contact pointPROF. GIORGIO VITTORIO SCAGLIOTTI
    B.5.3 Address:
    B.5.3.1Street AddressREGIONE GONZOLE N. 10
    B.5.3.2Town/ cityORBASSANO -TORINO
    B.5.3.3Post code10043
    B.5.3.4CountryItaly
    B.5.4Telephone number00390119026414
    B.5.5Fax number00390119015184
    B.5.6E-mailgiorgio.scagliotti@unito.it
    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 ZYTIGA
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL NV
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameZYTIGA
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Yes
    D.3.11.13.1Other medicinal product typehormone therapy
    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 PATIENTS WITH HIGH RISK
    E.1.1.1Medical condition in easily understood language
    PROSTATE CANCER PATIENTS WITH HIGH RISK
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Evaluate the effect of short-term treatment with abiraterone acetate and LHRH analogue on pathological complete response + almost complete (residual disease <5mm) after radical prostatectomy
    E.2.2Secondary objectives of the trial
    • Evaluate the rate of pathologic complete response after radical prostatectomy
    • Evaluate the response rate serum (PSA)
    • To evaluate the effect of neoadjuvant hormonal treatment on serum concentrations of testosterone and androgens
    • Assess changes in serum markers of bone turnover: bone isoenzyme of bone alkaline phosphatase (BSAP) and carboxy-terminal telopeptide of type I collagen (CTX)
    • To evaluate the effect of neoadjuvant hormonal treatment on the expression of tissue protein and gene expression biomarkers selected from different arms of the study and comparison of surgical and biopsy material of the same patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signature of the written informed consent and consent to the use of personal data
    • Age> 40 years, male
    • histological or cytological diagnosis of carcinoma of the prostate acinar type
    • absent lymph node involvement at diagnosis (as assessed by CT or MRI scan method)
    • Representative sample of tumor tissue biopsy material of> 5% of the total tissue sample (calculated as total mm of tumor tissue / mm total of frustules in examination)
    • Representative sample of tumor tissue evident on section area greater than 0.5 cm2 of material surgical prostatectomy (if the disease was multifocal it is necessary that the focus of larger size to meet the criteria)
    • high-risk disease defined as Gleason score> = 8 and / or PSA value> 20 ng / ml and / or disease> = cT3 (D'Amico classification)
    • Patients eligible radical prostatectomy
    E.4Principal exclusion criteria
    • Special histological types of carcinoma of the prostate
    • PSA> 100 ng / ml
    • Concomitant treatment with other antineoplastic agents including endocrine therapies experimental
    • Treatment with any investigational drug within 30 days prior to enrollment
    • Patients with a history of severe Hypersensitivity to any component of the drugs used in the clinical study
    E.5 End points
    E.5.1Primary end point(s)
    Evaluate the effect of short-term treatment with abiraterone acetate and LHRH analogue on pathological complete response + almost complete (residual disease <5mm) after radical prostatectomy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NOT APPLICABLE
    E.5.2Secondary end point(s)
    Evaluate the rate of pathologic complete response after radical prostatectomy
    • Evaluate the response rate serum (PSA)
    • To evaluate the effect of neoadjuvant hormonal treatment on serum concentrations of testosterone and androgens
    • Assess changes in serum markers of bone turnover: bone isoenzyme of bone alkaline phosphatase (BSAP) and carboxy-terminal telopeptide of type I collagen (CTX)
    • To evaluate the effect of neoadjuvant hormonal treatment on the expression of tissue protein and gene expression biomarkers selected from different arms of the study and comparison of surgical and biopsy material of the same patients
    E.5.2.1Timepoint(s) of evaluation of this end point
    NOT APPLICABLE
    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 No
    E.6.4Safety No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.7.1Other trial design description
    arm A treatment, LH-RH analogue; arm B treatment, LH-RH anologue with abiraterone acetate
    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
    arm A treatment, LH-RH analogue; arm B treatment, LH-RH anologue with abiraterone acetate
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    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 No
    E.8.7Trial has a data monitoring committee No
    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 months15
    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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state62
    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)
    After prostatectomy patients will be subjected to periodic follow-up visits at the urology reference. During these visits will be evaluated outcome of the PSA test previously performed and will be performed a rectal examination. The expected timing of such visits is as follows: after 6 weeks of prostatectomy and then the 3rd, 6th and 12th month after prostatectomy, every 6 months for the next 3 years and then annually.
    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 Decision2013-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-15
    P. End of Trial
    P.End of Trial StatusOngoing
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