Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-004210-28
    Sponsor's Protocol Code Number:I-1315
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-12
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2014-004210-28
    A.3Full title of the trial
    68Ga-PSMA PET/CT vs. MRI/CT vs. lymphadenectomy for the identification of lymph node metastases in locally advanced prostate cancer patients: a diagnostic test accuracy study
    68Ga-PSMA PET/CT versus MR/CT versus lymphadenektomi til identifikation af lymfeknudemetastaser hos patienter med lokal avanceret prostatacancer: et diagnostisk akkuratesse studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two methods for the identifacation of lymph node metastases in patients with locally advanced prostate cancer
    Sammenligning af to metoder til at identificere lymfeknudemetastaser i patienter med lokal fremskreden prostatakræft
    A.4.1Sponsor's protocol code numberI-1315
    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 SponsorDepartment of Nuclear Medicine, Aalborg University Hospital
    B.1.3.4CountryDenmark
    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 supportThe Obel Family Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Nuclear Medicine, Aalborg University Hospital
    B.5.2Functional name of contact pointLars Jelstrup Petersen
    B.5.3 Address:
    B.5.3.1Street AddressHobrovej 18-22
    B.5.3.2Town/ cityAalborg
    B.5.3.3Post code9000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4597665484
    B.5.6E-maillajp@rn.dk
    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 name68Ga-PSMA-HBED-CC
    D.3.2Product code 68Ga-PSMA
    D.3.4Pharmaceutical form Solution for injection
    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 INN68Ga-PSMA-HBED-CC
    D.3.9.3Other descriptive name• 68Ga-‘2-[3-(1-Carboxy-5-{6-[3-(3-{[(2-{[4-(2-carboxy-ethyl)-2-hydroxy-benzyl]-carboxymethyl-amino}-ethyl)-carboxymethyl-amino]-methyl}-4-hydroxy-phenyl)-propionylamino]-hexanoylamino}-pentyl)-ureido]-pentanedioic acid
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeup to
    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
    Patients diagnosed with advanced prostate cancer that are scheduled for lymph node staging.
    Patienter diagnosticeret med lokal avanceret prostatacancer, der er henvist til lymphadenektomi.
    E.1.1.1Medical condition in easily understood language
    Patient diagnosed with prostate cancer.
    Patienter diagnosticeret med prostatakræft
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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 18.1
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10036223
    E.1.2Term Positron emission tomography
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the sensitivity and specificity of 68Ga-PSMA PET/CT versus MRI/CT against the reference test (lymphadenectomy) for the detection of lymph node metastasis on a patient-level in patients with locally advanced PCa.
    At undersøge sensitivitet og specificitet af 68Ga-PSMA PET/CT versus MR/CT i forhold til referencetesten (lymphadenektomi) til at detektere lymfeknudemetastaser på patient-basis i patienter med local avanceret prostatacancer.
    E.2.2Secondary objectives of the trial
    To investigate the sensitivity and specificity of 68Ga-PSMA PET/CT versus MRI/CT against the reference test (lymphadenectomy) for the detection of lymph node metastasis on a lesional (node-region) level.
    To investigate observer agreement in the assessment of 68Ga-PSMA PET/CT for local prostate involvement, nodal spread and bone metastasis if present.
    To assess the presence, if any, of bone metastasis in the axial skeleton as demonstrated by 68Ga-PSMA PET/CT and DW-MRI in patients with a metastasis-free bone scintigraphy performed as part of the standard staging procedure.
    At undersøge sensitivitet og specificitet af 68Ga-PSMA PET/CT versus MR/CT i forhold til referencetesten (lymphadenektomi) til at detektere lymfeknudemetastaser på læsion-basis (lymfeknude region).
    At undersøge observatør overensstemmelse i vurderingen af 68Ga-PSMA PET/CT til lokal prostatainvolvering, lymfeknude- og knoglemetastaser, hvis muligt.
    At undersøge mulig tilstedeværelse af knoglemetastaser i det aksiale skelet ved 68Ga-PSMA PET/CT og diffusionvægtet MR hos patienter med metastase-fri knogleskintigrafi udført som del af normal procedure.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Oral and written informed consent.
    18 years and older.
    Histological confirmed adenocarcinoma of the prostate.
    Routine bone scintigraphy without metastasis.
    Referred for lymph node staging as standard clinical practice - either concurrent with surgical removal of the prostate (radical prostatectomy) or prior to curative (radiation therapy) or palliative (hormonal) treatment.
    Mundtlig og skriftlig informeret samtykke.
    18 år og ældre.
    Histologisk bekræftet prostataadenokarcinom.
    Rutine knogleskintigrafi uden metastaser.
    Henvist til lymphadenektomi som del af standard klinisk praksis - enten samtidig med operativ fjernelse af prostata (radikal prostatektomi) eller før kurativ (strålebehandling) eller palliativ (hormon) behandling.
    E.4Principal exclusion criteria
    Prior or current therapy for prostate cancer.
    History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer.
    History of allergic reactions attributed to compounds of 68Ga-PSMA radiotracer.
    Subjects unable to undergo 68Ga PSMA PET/CT imaging procedure (e.g. claustrophobia despite oral anxiolytics).
    Subjects weighing greater than 180 kilograms (weight limit for scanner table), or unable to fit within the imaging gantry.
    Subjects with any medical condition or other circumstances (e.g. claustrophobia, unable to lie still, unable to comply with study procedures etc.) that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study.
    If the patient refuses MRI or is not eligible (known with e.g. claustrophobia or other reasons as outlined in the ESUR guideline for MRI), the patient will be offered a diagnostic CT in combination with 68Ga-PSMA PET. If the patient refuses a diagnostic CT scan or allergic or ineligible for such procedure only a 68Ga-PSMA PET/low dose CT will be performed. Such patients will be assessed for secondary endpoints only.
    Tidlig eller nuværende behandling for prostatacancer.
    Anden cancersygdom inden for de seneste fem år bortset fra kurativ behandlet non-melanom hudcancer.
    Allergisk reaktion mod indholdstoffer i 68Ga-PSMA sporstoffet.
    Patienter ude af stand til at gennemføre 68Ga-PSMA PET/CT skanningen (fx klaustrofobi til trods for behandling med oral anxiolytikum).
    Patienter med kropsvægt over 180 kg (vægtbegrænsning for skanner) eller med andre begrænsninger i forhold til skannerens størrelse.
    Patienter med en sygdomstilstand eller andre omstændigheder (fx klaustrofobi, manglende evne til at ligge stille og lignende), der efter investigators opfattelse vil nedsætte datapålidelighed samt muligheden for at gennemføre studiet.
    Hvis patienten nægter eller af andre årsager ikke er i stand til at gennemføre MR-skanningen, vil patienten tilbydes en diagnostisk CT-skanning i kombination med 68Ga-PSMA PET-skanningen. Patienter, der nægter, er allergiske eller på anden måde uegnet til diagnostisk CT, vil få udført en 68Ga-PSMA PET i kombination med en lavdosis CT-skanning. Disse patienter vil kun blive evalueret i forhold til de sekundære endepunkter.
    E.5 End points
    E.5.1Primary end point(s)
    A sensitivity of at least 90% of the 68Ga-PSMA PET/CT.
    En sensitivitet på minimum 90% for 68Ga-PSMA PET/CT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of end points will be done after 70 patients have accomplished this study.
    Evaluering af endepunkter vil ske, når 70 patienter har gennemført studiet.
    E.5.2Secondary end point(s)
    To evaluate observer agreement when 68Ga-PSMA is used for detection of local prostate cancer, lymph node and bone metastases.
    To assess if 68Ga-PSMA PET/CT and diffusion weighted MRI can detect bone metastases not identified in standard staging procedure.
    At evaluere observatør overensstemmelse, når 68Ga-PSMA anvendes til at detektere lokal prostatacancer, lymfeknude- og knoglemetastaser.
    At vurdere om 68Ga-PSMA PET/CT og diffusionsvægtet MR-skanning kan detektere knoglemetastaser, der ikke er fundet på knogleskintigrafi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of end points will be done after 70 patients have accomplished this study.
    Evaluering af endepunkter vil ske, når 70 patienter har gennemført studiet.
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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
    The Investigator can exclude the patient from the study due to serious adverse event (SAE), serious adverse reaction (SAR), suspected unexpected serious adverse reaction (SUSAR) or severe non-compliance with study procedures.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state70
    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)
    No study specific treatment. The patients are treated as institutional practice and national guidelines prescribe.
    Ingen studiespecifik behandling. Patienterne behandles ifølge hospitalspraksis og nationale retningslinjer.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Department of Urology, Aalborg University Hospital
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Department of Urology, Viborg Regional Hospital
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Department of Radiology, Aalborg University Hospital
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Department of Diagnostic Radiology, The Institut of Cancer Research
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Department of Urology, Holstebro Regional Hospital
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-31
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 20:06:16 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA