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    Summary
    EudraCT Number:2016-004774-17
    Sponsor's Protocol Code Number:ESTO2
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-15
    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 ConcernedFinland - Fimea
    A.2EudraCT number2016-004774-17
    A.3Full title of the trial
    Impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy – lipid metabolism as a novel biomarker to predict prostate cancer progression – phase 3, double-blind randomized clinical trial
    Atorvastatiinin käytön vaikutus eturauhassyövän kehitykseen hormoni/ kastraatiohoidossa oleville potilaille-TUTKIMUS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy
    Atorvastatiinin käytön vaikutus eturauhassyövän kehitykseen hormoni/ kastraatiohoidossa oleville potilaille-TUTKIMUS
    A.4.1Sponsor's protocol code numberESTO2
    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 SponsorPirkanmaan sairaanhoitopiiri
    B.1.3.4CountryFinland
    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 supportSuomen syöpäsäätiö
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportPirkanmaan sairaanhoitopiiri
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPirkanmaan sairaanhoitopiiri
    B.5.2Functional name of contact pointTampereen yliopistollinen sairaala
    B.5.3 Address:
    B.5.3.1Street AddressPL 2000
    B.5.3.2Town/ cityTampere
    B.5.3.3Post code33521
    B.5.3.4CountryFinland
    B.5.6E-mailteemu.murtola@pshp.fi
    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 Atorvastatin 80 mg, saatavuuden mukaan voidaan joutua vaihtamaan kauppanimeä tutkimuksen kuluessa.
    D.2.1.1.2Name of the Marketing Authorisation holderVoi vaihdella
    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 nameUseita
    D.3.4Pharmaceutical form Capsule
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic prostate cancer managed with androgen deprivation therapy
    Metastaattinen eturauhassyöpä jonka hoidoksi aloitetaan kastraatiohoito
    E.1.1.1Medical condition in easily understood language
    Metastatic prostate cancer managed with androgen deprivation therapy
    Levinnyt eturauhassyöpä jonka hoidoksi aloitetaan hormonihoito
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10036911
    E.1.2Term Prostate cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066489
    E.1.2Term Progression of prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant 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
    This trial explores whether intervention with atorvastatin delays prostate cancer progression i.e. development of castration resistance compared to placebo during androgen deprivation therapy (ADT) for metastatic prostate cancer.
    Tämän tutkimuksen päätavoitteena on tutkia vaikuttaako päivittäinen annos atorvastatiinia eturauhassyövän uusiutumiseen kastraatio/hormonihoidossa olevilla potilailla.
    E.2.2Secondary objectives of the trial
    Secondary objectives include exploring whether atorvastatin lowers prostate cancer-specific or overall mortality compared to placebo, and to demonstrate whether changes in serum lipid parameters predict disease recurrence and whether atrovastatin prevents occurrence of adverse tumor genomic traits predicting castration resistance among prostate cancer patients during ADT.
    Tutkimuksen muina tavoitteina on selvittää vaikuttaako atorvastatiinin käyttö eturauhassyöpäkuolleisuuteen tai yleiseen kuolleisuuteen, voidaanko kastraatiohoidon aikana ilmaantuvien veren rasva-aineprofiilin muutosten avulla ennustaa sairauden uusiutumaa sekä estääkö atorvatatiini haitallisten genomisten muutosten ilmaantumista eturauhasyöpäpotilailla kastraatio/hormonihoidon aikana.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histopathologically confirmed metastatic adenocarcinoma of the prostate (radiologically confirmed bone or soft tissue metastasis or enlarged lymph nodes at minimum 15 mm in diameter beyond the pelvic lymph nodes) for which androgen deprivation or antiandrogen therapy (GnRH agonist/antagonist, bicalutamide/flutamide, surgical castration or enzalutamide/abiraterone monotherapy) is initiated no longer than 3 months before recruitment
    o previous prostatectomy and radiation therapy allowed
    2. The participant is willing to participate and signs informed consent
    1. Histopatologisesti varmennettu levinnyt eturauhassyöpä (joko kuvantaen todetut metastaasit luustossa tai pehmytkudoksisa tai läpimitaltaan vähintään 15 mm kokoisia suurentuneita imusolmukkeita muualla kuin lantion alueella), johon on valittu primaariseksi hoitomuodoksi kastraatio/hormonihoito (GnRH agonisti/antagonisti, bikalutamidi/flutamidi, kirurginen kastraatio tai entsalutamidi/abirateroni monoterapia) korkeintaan kolme kuukautta ennen tutkimukseen mukan tulemista
    2. Potilas on halukas osallistumaan tutkimukseen ja allekirjoittaa suostumuksen osallistumiselleen
    E.4Principal exclusion criteria
    - Androgen deprivation initiated as temporary neoadjuvant treatment
    - Statin use at the time of recruitment or within 6 months of it
    - Previous adverse effects during statin therapy
    - Familial hypercholesterolemia or very high total cholesterol (9.3 mmol/l or above)
    - Clinically significant renal insufficiency (serum creatinine above 170 µmol/l) or liver insufficiency (serum alanine aminotransferase more than 2x above the upper limit of normal range)
    - Use of drugs that may interact with statins (St John’s Wort, HIV protease inhibitors, ciclosporin, macrolide antibiotics, fucidic acid, phenytoin, carbamazepine, dronedarone or oral antifungal medication).
    - Kastraatiohoito aloitettu väliaikaisena neoadjuvanttihoitona
    - Statiinien käyttö kuuden kuukauden sisällä ennen tutkimukseen mukaantuloa
    - Aiemmat haittavaikutukset statiinien käytöstä
    - Familiaalinen hyperkolesterolemia tai erittäin korkea veren kokonaiskolesteroli pitoisuus (9,3 mmol/l tai enemmän)
    - Kliinisesti merkittävä munuaisten tai maksan vajaatoiminta (seerumin kreatiniini yli 170 µmol/l ja seerumin alaniini aminotransferaasi yli 100 U/l)
    - Statiinien kanssa yhteisvaikututtavien lääkkeiden käyttö (mäkikuisma, HIV proteaasi-inhibiittorit, siklosporiini, makrolidi-antibiootit, fusidiinihappo, fenytoiini, karbamatsepiini, dronedaroni tai oraaliset sienilääkkeet).
    E.5 End points
    E.5.1Primary end point(s)
    Development of castration resistance during androgen deprivation therapy, defined as either PSA progression (three consecutive rises of PSA measured at least 1 week apart with two > 50% increases over the nadir and PSA > 2 ng/ml) or radiological progression (appearance of two or more lesions in bone scan or soft tissue enlargement as per RECIST criteria) while serum testosterone is at castrate level (< 50 ng/ml or 1.7 nmol/l).

    Kastraatioresistenssin kehittyminen hormonihoidon aikana. Kastraatioresistentiksi määritellään joko PSA progressio (kolme peräkkäin nousevaa PSA arvoa vähintään viikon väliajoin mitattuna, kaksi >50% nousua alimpaan arvoon verrattuna sekä kokonaisPSA > 2ng/ml) tai radiologinen tautiprogressio (kuvantaen todettu kaksi uutta luustopesäkettä tai enemmän tai RECIST kriteerien mukainen pehmytkudospesäke) seerumin testosteroniarvon ollessa katraattitasolla (< 50ng/ml tai 1.7 mmol/l).
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of the study e.g. progression of castration resistance or 10 years after initiation
    Kastraatioresistenssin kehittyminen tai 10 vuotta tutkimuksen aloituksesta
    E.5.2Secondary end point(s)
    Change in serum cholesterol during the intervention and its role in predicting time to disease recurrence in the placebo arm, prostate cancer mortality and overall survival, - occurrence of adverse tumor traits predicting development of castration resistance in circulating cell free DNA, - changes in fasting blood glucose during ADT, occurrence of cardiovascular events during ADT and - quality of life during ADT
    Muutokset seerumin kolesteroli arvoissa ,eturauhassyöpä kuolleisuus ja kokonaiseloonjäänti, muutokset paastoglukoosissa, sydän- ja verisuonisairauksien ja tapahtumien yleisyys, sekä elämänlaatu hormoni/kastraatiohoidon aikana.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At each control visit which are scheduled at 6 month intervals for maximum of 10 years after recruitment
    Jokaisen 6 kk välein pidettävän kontrollikäynnin yhteydessä, jokta jatkuvat maksimissaan 10 vuoden ajan tutkimukseen mukaantulon jälkeen
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    The trial ends when all participants have met the primary endpoint, i.e. developed castration-resistance or have been under follow-up for the maximum 10 years. After the trial ended survival of the participants will be followed via national registries.
    Tutkimus päättyy kun kaikille osallistujille on kehittynyt primääri päätetaphtuma eli kastraatioresistenssi tai kun he ovat olleet maksimimäärän kymmenen vuoden ajan seurannassa. Tutkimuksen päättymisen jälkeen osallistujien elossaoloa seurataan kansallisen rekisteriden välityksellä
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 400
    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 the trial participants will be managed according to standard prostate cancer management guidelines
    Tutkimuksen jälkeen potilaat hoidetaan normaalin hoitokäytännön mukaisesti
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation FinnProstata rresearch group
    G.4.3.4Network Country Finland
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-16
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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