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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41449   clinical trials with a EudraCT protocol, of which   6808   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2021-001123-40
    Sponsor's Protocol Code Number:RENARD
    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:2021-04-22
    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 number2021-001123-40
    A.3Full title of the trial
    18F-fluciclovine PET/CT and 18F-DCFPyL PET/CT in patients with biochemical recurrence of disease after radical prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial
    18F-fluciclovine PET/CT en 18F-DCFPyL PET/CT bij patienten met biochemisch recidief na radicale prostatectomie: een prospectief, mono-center, single-arm vergelijkende beeldvormingsstudie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective imaging study with 18F-fluciclovine PET/CT and 18F-DCFPyL in patients with biochemical reccurence of prostate cancer.
    Een prospectief onderzoek naar beeldvorming met 18F-fluciclovine PET/CT en 18F-DCFPyl PET/CT bij patiënten met een biochemisch recidief van prostaatkanker.
    A.3.2Name or abbreviated title of the trial where available
    RENARD trial
    RENARD studie
    A.4.1Sponsor's protocol code numberRENARD
    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 SponsorAmsterdam UMC, VU University Medical Center
    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 supportCurium PET France
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC, VU University Medical Center
    B.5.2Functional name of contact pointDepartment of Nuclear Medicine
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31204444214
    B.5.6E-maild.oprea-lager@amsterdamumc.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 nameDCFPyL
    D.3.2Product code DCFPyL
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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
    Prostate cancer
    Prostaat kanker
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    Prostaat kanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To head-to-head compare the imaging performance of 18F-fluciclovine PET/low-dose CT and 18F-DCFPyL PET/low-dose CT in patients with BCR of PCa after radical prostatectomy.
    E.2.2Secondary objectives of the trial
    1.the detection rates on a patient-based analysis of 18F-DCFPyL and 18F-fluciclovine PET/CT stratified by PSA level (0.2-0.5; 0.51-1.0; 1.01-2.0 ng/mL);
    2.the per-region detection rate of 18F-fluciclovine versus 18F-DCFPyL;
    3.the side-effects of 18F-DCFPyL;
    4.the inter-observer agreement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male.
    Age ≥ 18 years.
    Histopathological confirmed prostate adenocarcinoma per original diagnosis.
    History of RARP.
    Biochemical recurrence of prostate cancer based on two consecutive measurable PSA levels of 0.2 -2.0 ng/mL.
    Ability to understand and sign the written informed consent form.
    Patients who can undergo all study procedures per investigator’s point of view.
    E.4Principal exclusion criteria
    Another active malignant tumor, except skin basal cell carcinoma.
    pN1 disease after ePLND.
    Any change in prostate cancer treatment between both PET/CT scans.
    History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection).
    History of salvage radiotherapy of the prostate bed.
    History of cryotherapy, high-intensity focused ultrasound (HIFU).
    Treatment with androgen deprivation therapy (ADT) in the past 30 days or ongoing.
    Unable to lie supine or still for imaging.
    Known allergy to investigational or reference products or to any excipients.
    Unable to provide written consent (linguistic or psychological inability).
    Uncooperative, in the Investigator’s opinion.
    E.5 End points
    E.5.1Primary end point(s)
    1.To compare the per patient detection rates (i.e., the proportion of patients with PET-positive findings) of 18F-fluciclovine (reference test) versus 18F-DCFPyL PET/CT (index test) for the identification of tumour location(s) patients with BCR of disease after RARP (PSA <0.2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    We expect to complete the patient inclusion in 9 months. Data analysis and document writing will require 2-3 months.
    E.5.2Secondary end point(s)
    2. the detection rates on a patient-based analysis of 18F-DCFPyL and 18F-fluciclovine PET/CT stratified by PSA level (0.2-0.5; 0.51-1.0; 1.01-2.0 ng/mL);
    3. the per-region detection rate of 18F-fluciclovine versus 18F-DCFPyL;
    4. the side-effects of 18F-DCFPyL;
    5. the inter-observer agreement.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see above.
    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 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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 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
    The end of the study is defined as the last patients' last visit on the department of radiology and nuclear imaging from the Amsterdam UMC, VU University Medical Center, after a succesfully performed and completed PET/CT scan.
    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 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: 20
    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 state50
    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 study will have no influence on the therapy management of the patients. The patients included in the study will be treated conform standard procedures/guidelines, regular care.
    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 Decision2021-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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