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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-005431-86
    Sponsor's Protocol Code Number:FuTuRe
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-06-18
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-005431-86
    A.3Full title of the trial
    Evaluation of 18F-FDHT PET/CT as an early treatment response marker in patients with metastasized castration-resistant prostate cancer to be treated with enzalutamide.
    Evaluatie van 18F-FDHT PET/CT als vroege therapie respons marker bij patiënten met castratie resistent prostaatkanker die behandeld worden met enzalutamide.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of 18F-FDHT PET/CT as an early treatment response marker in patients with metastasized castration-resistant prostate cancer to be treated with enzalutamide.
    Evaluatie van 18F-FDHT PET/CT als vroege therapie respons marker bij patiënten met castratie resistent prostaatkanker die behandeld worden met enzalutamide.
    A.3.2Name or abbreviated title of the trial where available
    18F-FDHT PET/CT as an early Treatment Response marker
    18F-FDHT PET/CT als vroege Therapie Respons marker
    A.4.1Sponsor's protocol code numberFuTuRe
    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 SponsorUniversity Medical Center Groningen
    B.1.3.4CountryNetherlands
    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 supportCenter for Translational Molecular Medicine (CTMM), Prostate Cancer Molecular Medicine (PCMM) project
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointDepartment of Urology
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031503619952
    B.5.5Fax number0031503619607
    B.5.6E-mailh.d.hoving@umcg.nl
    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 No
    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 nameenzalutamide
    D.3.2Product code MDV3100
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    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 INNENZALUTAMIDE
    D.3.9.1CAS number 915087-33-1
    D.3.9.4EV Substance CodeSUB77412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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.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 No
    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 name16β-[18F]-fluoro-5α-dihydrotestosterone
    D.3.2Product code 18F-FDHT
    D.3.4Pharmaceutical form Radiopharmaceutical precursor, solution
    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 INN16β-[18F]-fluoro-5α-dihydrotestosterone
    D.3.9.1CAS number 142713-31-3
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    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
    Castration-resistant prostate cancer
    Castratie resistent prostaatkanker
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    Prostaatkanker
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    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
    Primary objective is to evaluate 18F-FDHTPET/CT as an early treatment response marker in patients with metastasized CRPC to be treated with enzalutamide.
    Het eerste doel van het onderzoek is om het effect van de behandeling met enzalutamide te meten door middel van 18F-FDHT PET/CT scans.
    E.2.2Secondary objectives of the trial
    Secondary objective is to collect biopsies of prostate cancer bone and/or lymph node metastases, blood and urine specimens for future research.
    Het tweede doel van het onderzoek is om weefsel van prostaatkanker bot en/of lymfeklier metastasen, bloed en urine (biomateriaal) te verzamelen voor toekomstig onderzoek.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 50 or older.
    2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
    3. Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone analogue or bilateral orchidectomy.
    4. Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bone disease.
    5. Metastatic disease documented by bone lesions on bone scan or by measurable soft tissue disease by CT
    6. No prior cytotoxic chemotherapy for prostate cancer.
    7. Asymptomatic or mildly symptomatic from prostate cancer
    1. Leeftijd ≥ 50 jaar.
    2. Histologisch of cytologisch bewezen adenocarcinoom van de prostaat zonder neuroendocriene differentiatie of kenmerken van een kleincellig carcinoom.
    3. Onderhoudsbehandeling met androgene deprivatie therapie met een ganadotropine-releasing horomoon analoog of een bilaterale orchiectomie.
    4. Progressieve ziekte ondanks androgene deprivatie therapie gedefinieerd door middel van PSA stijging of progressieve ziekte in de weke delen of in de botten.
    5. Metastases gedocumenteerd als botmetastasen op de botscan of weke delen metastasen op de CT scan.
    6. Geen cytotoxische chemotherapie voor prostaatkanker.
    7. Asymptomatisch of mild symptomatisch ten gevolge van prostaatkanker.
    E.4Principal exclusion criteria
    1. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
    2. Known or suspected brain metastasis or active leptomeningeal disease.
    3. History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer.
    1. Ernstige gelijktijdige ziekte, infectie of comorbiditeit, waardoor de patiënt volgens de onderzoeker niet in aanmerking komt voor inclusie.
    2. Bekende of suspecte hersenmetastasen of actieve leptomeningeale ziekte.
    3. Voorgeschiedenis van een maligniteit anders dan curatief behandelde niet-melanomateuze huidkanker in de afgelopen 5 jaar.
    E.5 End points
    E.5.1Primary end point(s)
    Association of 18F-FDHT PET/CT prior to start of enzalutamide (study week 1) with treatment response.
    Association of delta (study week 1 and 5) 18F-FDHT PET/CT with treatment response.
    Associatie van 18F-FDHT PET/CT vòòr start enzalutamide (studie week 1) met therapie respons.
    Associatie van delta (studie week 1 – week 5) 18F-FDHT PET/CT met therapie respons.
    E.5.1.1Timepoint(s) of evaluation of this end point
    See above E.5.1.
    Zie hierboven E.5.1.
    E.5.2Secondary end point(s)
    Collection and storage of biomaterial for future research.
    Biomateriaal zal opgeslagen worden in de biobank voor de uitvoering van experimenten in de toekomst.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Prior to start of enzalutamide (study week 1) and after 12 weeks of treatment (study week 13)
    Vòòr start van enzalutamide (study week 1) en na 12 weken therapie (studie week 13)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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 No
    E.8.1.1Randomised No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    Each year, up to 5 years after enrollment in the current study, the medical record will be checked for secondary endpoints of the primary objective, like survival, etc.
    Jaarlijks, tot 5 jaar na inclusie, zal het medisch dossier gecontroleerd worden op secondaire eindpunten van de primaire onderzoeksvraag, zoals overleving, etc.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state60
    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)
    The plans for treatment or care after the subject has ended the participation in the trial are not different from the expected normal treatment of that condition.
    De behandeling en zorg voor de patiënt, na deelname aan de studie, is niet anders dan de behandeling en zorg voor patiënten met de ziekte die niet deelgenomen hebben aan de studie.
    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 Center for Translational Molecular Medicine
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-10
    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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