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    Summary
    EudraCT Number:2019-003284-21
    Sponsor's Protocol Code Number:71151
    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:2019-12-02
    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 number2019-003284-21
    A.3Full title of the trial
    Radio guided lymph node dissection in oligo metastatic prostate cancer patients; a feasibility study
    Radioligand gestuurde lymfeklier dissecties bij prostaatkanker patienten met oligo-gemetastaseerde ziekte.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lymph node surgery using a radioactive tracer in prostatecancer patients with lymph node involvement
    Lymfeklierdissecties met behulp van een radioactieve tracer bij prostaaatkanker patienten met lymfeklier metastasen.
    A.3.2Name or abbreviated title of the trial where available
    DETECT
    DETECT
    A.4.1Sponsor's protocol code number71151
    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 SponsorRadboudumc
    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 supportRadboudumc
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud university medical center
    B.5.2Functional name of contact pointDep. Radiology & Nuclear Medicine
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.6E-mailmelline.schilham@radboudumc.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 nameIndium-111-PSMA-Imaging & Therapy
    D.3.2Product code In-111 PSMA-I&T
    D.3.4Pharmaceutical form Radiopharmaceutical precursor
    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 INN111-In PSMA-I&T
    D.3.9.3Other descriptive nameIn-111-((R)-DOTAGA-(l-y)fk(Sub-KuE)
    D.3.9.4EV Substance CodeSUB171041
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 prostate cancer upon prostate biopsy, who are suspected of having lymph node involvement based upon PSMA-PET/CT.
    Patienten met prostaat kanker gediagnosticeerd op basis van prostaatbiopten en hoog risico op lymfeklier metastasen gebaseerd op PSMA-PET/CT.
    E.1.1.1Medical condition in easily understood language
    Prostatecancer patients, highly suspected of lymph node involvement.
    prostaatkankerpatiënten met hoge verdenking op lymfeklier metastasering.
    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
    To investigate the feasibility of radio-guided Pelvic Lymph node dissection in prostate cancer patients using Indium-111 labelled PSMA_I&T
    Het onderzoeken van de mogelijkheid om pelviene lymfeklier dissecties uit te voeren met behulp van de radioactieve tracer In-111-PSMA-I&T bij prostaatkanker patienten.
    E.2.2Secondary objectives of the trial
    • To compare the intra operative tracer detection (gamma-probe) results with ex vivo findings on SPECT/CT and MRI of resected samples.
    • To compare both nano-MRI images and SPECT/CT images of resected samples with histopathologic findings.
    • To correlate intra operative tracer detection results and SPECT/CT images with PSMA-staining on histopathologic examination.
    • To correlate amount of gamma-counts with tumour(metastases) size.
    • To assess safety of 111In-PSMA-I&T by monitoring (S)AE’s according to the common terminology criteria for adverse events (CTCAE).

    • Vergelijken van gamma probe resultaten (tracer detectie) met ex vivo finding on nano-MRI images and SPECT/CT images.
    • Vergelijken van pre-operatieve nano-MRI en PSMA-PET/CT resultaten met histopathologische resultaten.
    • Correleren van intraoperatieve tracer detectie met PSMA-kleuring van histopathologie.
    • Correleren van interaoperatieve gamma-counts (kwantitatief) met tumor grootte (klier grootte).
    • Beoordelen van de veiligheid van 111In-PSMA-I&T door middel van registratie van bijwerkingen.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Histological proven cancer of the prostate, based on prostate biopsy-core analysis.
     At least one 68Ga/18F-PSMA-PET/CT positive metastasis in lymph nodes, located in pelvis.
     Patient is scheduled and fit for surgery (PLND or prostatectomy +PLND).
     Patient is suitable for PLND (and radical prostatectomy) conform institutional guidelines and is not yet treated pre-operatively.
     Age>18 years.
     Signed informed consent
     Histologisch bewezen prostaatkanker, gebaseerd op prostaat biopten.
     Ten minste één positieve lymfeklier metastase in het bekken op 68Ga/18F-PSMA-PET/CT.
     Patient moet in aanmerking komen voor chirurgische ingreep (in goede klinische conditie zijn).
     Patient moet volgens de lokaal geldende richtlijnen in aanmerking komen voor chirurgische behandeling en niet eerder andere therapie hebben ondergaan voor de prostaatkanker.
     Leeftijd >18 jaar.
     Patiënt moet adequaat geïnformeerd zijn en schriftelijk toestemming hebben gegeven voor deelname.
    E.4Principal exclusion criteria
     No detectable lesion on the 68Ga/18F-PSMA-PET/CT with an uptake level below liver uptake level.
     Patients who are not scheduled for PLND.
     Unequivocal evidence of metastases outside the pelvis.
     Presence of any medical condition that in the opinion of the investigator/treating physician will affect patients’ clinical status by participating in this trial.
     Prior prostate cancer treatment in the form of radio-, hormonal- or chemotherapy.
     Laboratory values at baseline:
    - White blood cells < 3.5 *109/L
    - Platelet count < 150*109/L
    - Haemoglobin < 6 mmol/L
    - ASAT, ALAT > 3 ULN
    - GFR < 60 ml/min
     Contraindication for MRI-scanning, i.e. claustrophobia, intracranial metal clips, metallic bodies in the eye, implanted electric and electronic devices not eligible for MRI (pacemakers, insulin pumps, cochlear implants, neurostimulators).
     Inability to lie still for at least 30 minutes or comply with imaging.
     Contraindication for iron infusion or hypersensitivity/allergy to the active substance or any of the excipients.
     The patient is already enrolled in one or more concurrent studies, which would confound the results of this study, according to the investigators.

     Geen detecteerbare leasie op 68Ga/18F-PSMA-PET/CT met een opname van meer dan de lever opname.
     Patienten die niet voldoen aan de inclusie criteria.
     Duidelijk bewijs voor metastasering buiten het bekken.
     De aanwezigheid van een medische conditie welke volgens de onderzoeker of behandelend arts negatieve invloed zal hebben op de klinische status van de patiënt door deelname aan het onderzoek.
     Eerdere behandeling voor prostaatkanker in de vorm van hormonale-, radio- of chemotherapie.
     Bloedwaarden ten tijde van de inclusie:
    - Witte bloedcellen < 3.5 *109/L
    - Trombocyten < 150*109/L
    - Haemoglobine < 6 mmol/L
    - ASAT, ALAT > 3 ULN
    - GFR < 60 ml/min
     Contraindicatie voor MRI-scans, i.e. claustrophobie, intercraniele metalen clips, metalen in het oog, geimplanteerde elektrische en elektronische apparaten welke niet geschikt zijn voor MRI (pacemakers, insuline pompen, cochleaire implantaten, neurostimulators).
     Geen mogelijkheid om stil te liggen voor tenminste 30 minuten of mee te werken aan beeldvormend onderzoek.
     Contraindicatie voor ijzer infusie of hypersensitiviteit/allergie voor een van de substanties van de toe te dienen producten.
     Deelname aan een of meer andere studies op het zelfde moment welke kunnen interfereren met de resultaten van de study volgens de onderzoekers.
    E.5 End points
    E.5.1Primary end point(s)
    The threshold in absolute gamma counts for identification of tumour-positive lymph nodes.
    The sensitivity and specificity of intra-operative tumour-positive lymph node detection.
    De drempelwaarde in gamma-counts voor de detectie van tumor positieve lymfeklieren.
    De sensitiviteit en specificiteit van intra-operatieve lymfekliermetastase detectie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After histoptahological examination results.
    Na de resultaten van de histopathologische onderzoeken.
    E.5.2Secondary end point(s)

    • To compare the intra operative tracer detection (gamma-probe) results with ex vivo findings on SPECT/CT and MRI of resected samples.
    • To compare both nano-MRI images and SPECT/CT images of resected samples with histopathologic findings.
    • To correlate intra operative tracer detection results and SPECT/CT images with PSMA-staining on histopathologic examination.
    • To correlate amount of gamma-counts with tumour(metastases) size.
    • To assess safety of 111In-PSMA-I&T by monitoring (S)AE’s according to the common terminology criteria for adverse events (CTCAE).

    • Vergelijken van gamma probe resultaten (tracer detectie) met ex vivo finding on nano-MRI images and SPECT/CT images.
    • Vergelijken van pre-operatieve nano-MRI en PSMA-PET/CT resultaten met histopathologische resultaten.
    • Correleren van intraoperatieve tracer detectie met PSMA-kleuring van histopathologie.
    • Correleren van interaoperatieve gamma-counts (kwantitatief) met tumor grootte (klier grootte).
    • Beoordelen van de veiligheid van 111In-PSMA-I&T door middel van registratie van bijwerkingen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    This can be evaluated after the ex-vivo scanning of the samples.
    Dit kan worden geëvalueerd na het ex-vivo scannen van de preparaten.
    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 Yes
    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) 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 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 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 concerned2
    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
    LVLS
    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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state20
    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)
    None
    geen
    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 Decision2019-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-13
    P. End of Trial
    P.End of Trial StatusOngoing
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