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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2021-003779-32
    Sponsor's Protocol Code Number:NL77171.091.21
    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:2021-08-10
    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 number2021-003779-32
    A.3Full title of the trial
    HYPo-fractionated Radiotherapy of Lymph Node Metastases guided by NanO-MRI in Prostate Cancer Patients: A Pilot Study (HYPNO-study).
    MRI-gestuurde radiotherapie van lymfekliermetastasen van prostaatcarcinoom, opgespoord met behulp van de nano-MRI (HYPNO-studie).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MRI-guided irradiation of prostate cancer lymph node metastases identified by nano-MRI.
    MRI-gestuurde bestraling van lymfeklieruitzaaiingen van prostaatkanker, opgespoord met behulp van de nano-MRI (HYPNO-studie).
    A.3.2Name or abbreviated title of the trial where available
    HYPNO-trial
    HYPNO-studie
    A.4.1Sponsor's protocol code numberNL77171.091.21
    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 SponsorRadboud 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 supportRadboud University Medical Center
    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 pointDepartment of Radiation Oncology
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein 32
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.6E-mailrobertjan.smeenk@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 nameFerumoxtran-10
    D.3.4Pharmaceutical form Infusion
    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 INNFerumoxtran-10 lyophilisate
    D.3.9.3Other descriptive nameSUPERPARAMAGNETIC IRON OXIDE NANOPARTICLES STABILISED WITH DEXTRAN AND SODIUM CITRATE, EXPRESSED IN QUANTITY OF IRON
    D.3.9.4EV Substance CodeSUB23227
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    men with biochemical recurrent prostate cancer after radical prostatectomy with ≤ 4 foci harbouring regional lymph node metastases (up to 6 lymph nodes in total) on nano-MRI.
    patiënten met biochemisch recidief prostaatcarcinoom na radicale prostatectomie met op nano-MRI ≤ 4 foci met regionale lymfekliermetastasen (maximaal 6 klieren in totaal).
    E.1.1.1Medical condition in easily understood language
    patients with rising PSA-levels after prostate removal with up to 6 lymph node metastases within the pelvis as seen on a nano-MRI scan.
    patiënten met stijgende PSA-waarde na prostaatverwijdering met op een nano-MRI scan maximaal 6 lymfeklieruitzaaiingen in het bekken.
    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 evaluate the technical feasibility and efficacy of MR-guided stereotactic body radiotherapy (SBRT) to nano-MRI detected regional lymph node metastases in patients with biochemical recurrent prostate cancer after radical prostatectomy.
    het evalueren van de technische haalbaarheid en effectiviteit van MR-geleide stereotactische radiotherapie op middels nano-MRI gedetecteerde lymfekliermetastasen bij patiënten met biochemisch recidief prostaatcarcinoom na radicale prostatectomie.
    E.2.2Secondary objectives of the trial
    - to determine the tolerability of the abovementioned treatment in terms of acute and late toxicity, both scored according to the Common Terminology Criteria for Adverse Events .
    - to determine the radiologic response of abovementioned treatment on repeated nano-MRI’s.
    - bepalen van de tolerantie van bovengenoemde behandeling in termen van acute en late toxiciteit, beide gescoord aan de hand van de Common Terminology Criteria for Adverse Events.
    - bepalen van de radiologische respons van bovengenoemde behandeling op herhaalde nano-MRIs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    - Biochemical recurrent prostate adenocarcinoma after radical prostatectomy.
    - PSA level ≥ 0.2 ng/ml
    - No macroscopic disease on PSMA-PET/CT
    - No local recurrence on MRI.
    - ≤ 4 foci harbouring regional lymph node metastases (up to 6 nodes in total) on nano-MRI (below aortic bifurcation).
    om deel te kunnen nemen aan de studie moeten patiënten aan de volgende criteria voldoen:
    - biochemisch recidief prostaatadenocarcinoom na radicale prostatectomie.
    - PSA-gehalte ≥ 0.2 ng/ml
    - geen macroscopische ziekte op PSMA-PET/CT
    - geen lokaal recidief op MRI
    - ≤ 4 foci van regionale lymfekliermetastasen (maximaal 6 klieren in totaal) op een nano-MRI (onder de aortabifurcatie).
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    - If any of the inclusion criteria does not apply.
    - Concurrent or previous androgen deprivation therapy.
    - Previous pelvic radiotherapy.
    - Active inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
    - Contraindication for MR-imaging according to local Radiology protocol or unable to undergo MR-linac treatment (e.g. due to claustrophobia or body circumference).
    - Ferro-magnetic objects in the pelvis or hip causing disturbing susceptibility artifacts (at the discretions of the radiologist).
    - Inability to give informed consent.
    - Contraindications to Ferrotran as stated in the SPC (including no consent to practice contraception until end of study in case of female partners of childbearing potential).
    Patiënten worden uitgesloten van deelname aan de studie in geval van één of meerdere van onderstaande factoren:
    - wanneer aan 1 van de inclusiecriteria niet wordt voldaan.
    - concurrente of eerdere androgene deprivatie therapie.
    - eerdere radiotherapie in het bekkengebied.
    - actieve inflammatoire darmziekte (M. Crohn of colitis ulcerosa).
    - contraindicatie voor MRI volgens de lokale protocollen van de Radiologie-afdeling of niet in staat MRI-onderzoek/behandeling te ondergaan (bv vanwege claustrofobie of lichaamsomvang).
    - ferromagnetische objecten in het bekken of de heupen, leidend tot verstorende susceptibiliteitsartefacten (naar oordeel van de radioloog).
    - niet in staat informed consent te geven.
    - contraindicaties voor Ferrotran, zoals beschreven in de SPC (inclusief wanneer, in geval van een vrouwelijke partner in de vruchtbare leeftijd, patiënt niet instemt met anticonceptieve middelen.
    E.5 End points
    E.5.1Primary end point(s)
    The main objective of this study is to determine the technical feasibility and efficacy of MRI guided lymph node SBRT in patients with biochemical recurrent prostate cancer after RP and small lymph node metastases on nano-MRI.
    - The study approach will be deemed technical feasible when in 90% of patients 1) the nano-MR detected lymph nodes can be objectified on the pre-radiotherapy planning MRI and daily MR-imaging, and 2) as a result can be treated by SBRT according to the set objectives and constraints without excessive > grade 2 treatment related toxicity (i.e. in > 5% of patients).
    - Efficacy will measured by the 1-year biochemical control, reflecting disease control. As no formal definition exists for a secondary biochemical relapse, in this study the 1-year biochemical control is defined as a PSA value 1 year after treatment that is < 0.2 ug/l higher than the value at baseline (in case of biochemical relapse confirmation after 6 weeks is needed)
    Het primaire eindpunt van de studie is de technische haalbaarheid en effectiviteit van MR-geleide stereotactische lymfeklierbestraling op middels nano-MRI gedetecteerde lymfekliermetastasen.
    - de studiebenadering wordt als technisch haalbaar beschouwd wanneer bij tenminste 90% van de patiënten 1) de middels nano-MRI gedecteerde lymfeklieren kunnen worden geobjectiveerd op de plannings-MRI en de dagelijkse online MRI's en 2) als een gevolg hiervan SBRT op deze klieren kan worden toegepast volgens de hiervoor opgestelde dosislimieten zonder overmatige > graad 2 toxiciteit (dat wil zeggen bij > 5 % van de patiënten).
    - effectiviteit zal worden bepaald op basis van de 1-jaars biochemische controle als surrogaat voor ziektecontrole. Aangezien er geen formele definitie bestaat voor een secundair biochemisch recidief wordt in de studie de 1-jaars biochemische controle gedefinieerd als een PSA-waarde < 0.2 ng/l hoger dan de baseline-waarde (in geval van een biochemisch recidief dient dit binnen 6 weken te worden bevestigd middels een herhaalde PSA-meting).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Technical feasibility: this will be determined before and during treatment.
    Efficacy: PSA-testing will take place at 3, 6, 9 and 12 (primary endpoint) months after treatment and afterwards according to standard of care.
    Technische haalbaarheid: dit zal voorafgaand en tijdens behandeling worden beoordeeld/bepaald.
    Effectiviteit: PSA-metingen vinden plaats op 3, 6, 9 en 12 (primaire eindpunt) maanden na behandeling en nadien volgens standaardzorg.
    E.5.2Secondary end point(s)
    - physician scored acute (until 90 days after treatment) and late toxicity measured by the Common Terminology Criteria for Adverse Events.
    - radiologic response of the treated lymph nodes on repeated nano-MRI at 3, 12 and 24 months after treatment will be determined and explorative analyses will be performed to see whether imaging biomarkers are correlated to biochemical outcome.
    - door de behandelend arts gescoorde acute (tot 90 dagen na behandeling) en late toxiciteit gebaseerd op de Common Terminology Criteria for Adverse Events.
    - radiologische respons van de behandelde lymfeklieren op herhaalde nano-MRI's na 3, 12 en 24 maanden. Exploratieve analyses zullen worden verricht om potentiele biomarkers te identificeren die gecorreleerd zijn aan biochemische controle.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Toxicity scoring will be performed at baseline, once during treatment, and 6 weeks after treatment, as well as 3, 6, 9, 12, 18, 24, 30 and 36 months after treatment and annually afterwards. The scoring will take place during regular follow-up visits.
    - repeated nano-MRI's will be performed at 3, 12 and 24 months after treatment.
    - toxiciteit wordt gescoord op baseline, eenmaal tijdens behandeling en 6 weken, 3, 6, 9, 12, 18, 24, 30, en 36 maanden na behandeling, gevolgd door jaarlijkse controle. Deze score vindt plaats tijdens reguliere follow-up bezoeken.
    - herhaalde nano-MRI's vinden plaats 3, 12 en 24 maanden na behandeling.
    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 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) 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 Yes
    E.8.1.7.1Other trial design description
    single-center, single arm pilot studie
    single-center, single arm pilot study
    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 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
    1 year after treatment of the final patient included in the trial. Afterwards, regular follow-up will continue according to standard of care.
    1 jaar behandeling van de laatste geincludeerde patiënt. Nadien vindt reguliere follow-up plaats conform standaardzorg.
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 Decision2021-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-27
    P. End of Trial
    P.End of Trial StatusOngoing
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