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    Summary
    EudraCT Number:2022-004115-92
    Sponsor's Protocol Code Number:1944/2022
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-31
    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 ConcernedAustria - BASG
    A.2EudraCT number2022-004115-92
    A.3Full title of the trial
    Neoadjuvant [177Lu]Lu-PSMAI&T radioligand therapy (PSMA-RLT) for patients with oligometastatic prostate
    cancer diagnosed using [68Ga]Ga-PSMA-11 PET imaging followed by radical prostatectomy: A Prospective Phase II Study
    Neoadjuvante [177Lu]Lu-PSMAI&T-Radioligandentherapie (PSMA-RLT) für Patienten mit oligometastasiertem Prostatakrebs, diagnostiziert mit [68Ga]Ga-PSMA-11-PET-Bildgebung, gefolgt von radikaler Prostatektomie: Eine prospektive Phase-II-Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Preoperative [177Lu]Lu-PSMAI&T radioligand therapy (PSMA-RLT) for patients with oligometastatic prostate
    cancer diagnosed using [68Ga]Ga-PSMA-11 PET imaging followed by radical prostatectomy: A Prospective Phase II Study
    Präoperative [177Lu]Lu-PSMAI&T-Radioligandentherapie (PSMA-RLT) für Patienten mit oligometastasiertem Prostatakrebs, diagnostiziert mit [68Ga]Ga-PSMA-11-PET-Bildgebung, gefolgt von radikaler Prostatektomie: Eine prospektive Phase-II-Studie
    A.3.2Name or abbreviated title of the trial where available
    Neoadjuvant PSMA-RLT in oligometastatic PCa
    Neoadjuvant PSMA-RLT in oligometastatic PCa.
    A.4.1Sponsor's protocol code number1944/2022
    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 SponsorMedical University of Vienna
    B.1.3.4CountryAustria
    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 supportMedical University of Vienna
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Vienna
    B.5.2Functional name of contact pointCoordination Center Clinical Study
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Straße 25a, Obergeschoß 1
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone numberÖster140160-25176
    B.5.5Fax numberÖster140160-925180
    B.5.6E-mailkks@meduniwien.ac.at
    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 name[177Lu]Lu-PSMA-I&T
    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 INNlutetium (177Lu) zadavotide guraxetan
    D.3.9.1CAS number 2447131-70-4
    D.3.9.3Other descriptive name[177Lu]Lu-PSMA-I&T
    D.3.9.4EV Substance CodeSUB199344
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Prostatakrebs
    E.1.1.1Medical condition in easily understood language
    Prostate Cancer
    Prostatakrebs
    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
    To analyze safety and toxicity of neoadjuvant PSMA-RLT and radical prostetectomy
    Analyse der Sicherheit und Toxizität der präoperativen PSMA-RLT und der radikalen Prostatektomie
    E.2.2Secondary objectives of the trial
    - PSA complete response to PSMA-RLT followed by radical prostetectomy
    - Imaging response and stability
    - Therapy-free survival after radical prostetectomy
    - Androgen depriviation therapy-free survival after radical prostetectomy
    - Time to castration-resistant prostate cancer
    - Quantification of circulating free tumor DNA (ctDNA) following PSMA-RLT and radical prostetectomy and during
    follow up.
    - Enumeration of circulating tumor cells (CTCs) during the study period
    - Molecular changes measured in liquid biopsy markers and tissue specimens following PSMARLT
    and radical prostetectomy
    - Feasibility of radical prostetectomy after PSMA-RLT
    - Patient’s quality of life under the systemic PSMA-RLT using the questionnaires: European
    Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)
    and Functional Assessment of Chronic Illness Therapy (FACT-P).
    - Vollständiges PSA-Ansprechen auf PSMA-RLT gefolgt von radikaler Prostatektomie
    - Bildgebendes Ansprechen und Stabilität
    - Therapiefreies Überleben nach radikaler Prostatektomie
    - Therapiefreies Überleben nach radikaler Prostatektomie mit Androgendeprivation
    - Zeit bis zum kastrationsresistenten Prostatakrebs
    - Quantifizierung der zirkulierenden freien Tumor-DNA (ctDNA) nach PSMA-RLT und radikaler Prostatektomie sowie während der
    Nachbeobachtung.
    - Auszählung von zirkulierenden Tumorzellen während des Studienzeitraums
    - Messung molekularer Veränderungen in Flüssigbiopsiemarkern und Gewebeproben nach PSMARLT
    und radikaler Prostatektomie
    - Durchführbarkeit der radikalen Prostatektomie nach PSMA-RLT
    - Lebensqualität der Patienten unter der systemischen PSMA-RLT anhand der Fragebögen: Europäische Organisation für Forschung und Behandlung von Krebs Lebensqualitätsfragebogen (EORTC QLQ)
    und Funktionelle Bewertung der Therapie chronischer Krankheiten (FACT-P).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients must be adults between 18 and 75 years of age.
    - Oligometastatic PCa diagnosed using [68Ga]Ga-PSMA-11 imaging defined as M1a and/or M1b positive with ≤5 osseous metastases and/or M1c ≤3 lung metastases
    - Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
    - Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 /L, Platelets ≥100 x 109 /L and Haemoglobin ≥9 g/dL.
    - Patients must have adequate renal function with eGFR ≥ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g/dL.
    - Patients must be able to sign Informed Consent Form.
    - Die Patienten müssen erwachsen und zwischen 18 und 75 Jahre alt sein.
    - Oligometastasierter PCa, diagnostiziert mittels [68Ga]Ga-PSMA-11-Bildgebung, definiert als M1a und/oder M1b
    positiv mit ≤5 knöchernen Metastasen und/oder M1c ≤3 Lungenmetastasen
    - Eastern Cooperative Oncology Group (ECOG) Leistungsstatus: 0-1
    - Die Patienten müssen über eine ausreichende Knochenmarkreserve verfügen: WBC ≥1,5 x 109 /L, Thrombozyten ≥100 x 109 /L und Hämoglobin ≥9 g/dL.
    - Die Patienten müssen über eine ausreichende Nierenfunktion mit einer eGFR ≥ 50mL/min/1,73m2 unter Anwendung der Modification of Diet Renal Disease (MDRD)-Gleichung und einem Albuminspiegel von ≥2,5 g/dL.
    - Die Patienten müssen in der Lage sein, eine Einverständniserklärung zu unterzeichnen.
    E.4Principal exclusion criteria
    - Concomitant participation in any other interventional trial.
    - Concurrent severe oncologic and medical conditions that result in patients not having a life
    expectancy of longer than the duration of the trial.
    - Nonmetastatic PCa on [68Ga]Ga-PSMA-11 imaging
    - more than 5 osseous metastases on [68Ga]Ga-PSMA-11 imaging
    - visceral metastases, apart from lungs
    - Age > 75 years.
    - Ongoing or previous androgen deprivation therapy with agonist or antagonist therapies.
    - Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study.
    - Complete urinary out-flow obstruction or severe unmanageable urinary incontinence
    - Gleichzeitige Teilnahme an einer anderen interventionellen Studie.
    - Gleichzeitige schwere onkologische und medizinische Erkrankungen, die dazu führen, dass die Lebenserwartung der Patienten nicht
    Lebenserwartung von mehr als der Dauer der Studie führen.
    - Nicht metastasierter PCa in der [68Ga]Ga-PSMA-11-Bildgebung
    - mehr als 5 knöcherne Metastasen in der [68Ga]Ga-PSMA-11-Bildgebung
    - viszerale Metastasen, außer in der Lunge
    - Alter > 75 Jahre.
    - Laufende oder frühere Androgenentzugstherapie mit Agonisten oder Antagonisten.
    - Vorhandensein klinisch relevanter somatischer oder psychiatrischer Erkrankungen, die die Ziele und Bewertungen der Studie beeinträchtigen könnten.
    - Vollständige Obstruktion des Harnabflusses oder schwere, nicht beherrschbare Harninkontinenz
    E.5 End points
    E.5.1Primary end point(s)
    Absolute rates of toxicity events defined as pathological decline of values of blood picture,
    kidney and liver functions from baseline levels assessed by CTCAE (v5.0). Absolute rates of periand
    postoperative (6 weeks) complications associated with radical prostetectomy assessed using Clavien-Dindo classification
    Absolute Raten von Toxizitätsereignissen, definiert als pathologische Verschlechterung der Werte des Blutbildes,
    Nieren- und Leberfunktionen gegenüber den Ausgangswerten, bewertet nach CTCAE (v5.0). Absolute Raten periund
    postoperativen (6 Wochen) Komplikationen im Zusammenhang mit der radikaler Prostatektomie, bewertet nach der Clavien-Dindo Klassifizierung
    E.5.1.1Timepoint(s) of evaluation of this end point
    After completion of both types of therapy
    Nach Abschluss beider Therapieformen
    E.5.2Secondary end point(s)
    - Rates of PSA response to the PSMA-RLT in terms of PSA decline of > 30% from baseline prior to radical prostetectomy.
    - Imaging response based on RECIST v1.1 and modified PET Response Criteria in Solid Tumors
    (PERCIST) 1.0 considered as: complete response with disappearance of all target and PSMA-avid
    lesions or partial response with at least a 30% decrease in the sum of the longest diameter and
    decrease of summed SUVmean or total tumor volume of ≥30% of target lesions from baseline
    images on [68Ga]Ga-PSMA-11 following PSMA-RLT.
    - Rates of complete PSA response defined as PSA <0.2ng/ml after radical prostetectomy and PSA progression survival
    defined as PSA rise to >50% above the nadir or administration of secondary therapies.
    - Therapy free survival after 2nd PSMA-RLT and radical prostetectomy, defined as time (months) from radical prostetectomy to first salvage PCa-directed radiation therapy, such as second-line systemic therapy and/or salvage radiotherapy.
    - AFS after 2nd PSMA-RLT and RP, defined as time (months) from radical prostetectomy to first administration of ADT
    therapy
    - Time from radical prostetectomy to castration-resistant prostate cancer (according to the EAU criteria [5])
    - Pathologic response at radical prostetectomy, measured as rates of pathologic complete response, minimal residual
    disease (≤5mm), pT3 disease, positive surgical margins, and lymph node metastasis.
    - Molecular changes measured in liquid markers and tissue specimens following PSMA-RLT and radical prostetectomy
    - ctDNA quantification and ciculating tumor cell enumeration
    - Determine patient’s quality of life under the systemic PSMA-RLT using the questionnaires:
    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
    (EORTC QLQ) and Functional Assessment of Chronic Illness Therapy (FACT-P).
    - PSA-Ansprechrate auf den PSMA-RLT im Sinne eines PSA-Rückgangs von > 30 % gegenüber dem Ausgangswert vor einer radikalen Prostatektomie.
    - Bildgebendes Ansprechen basierend auf RECIST v1.1 und modifizierten PET Response Criteria in Solid Tumors
    (PERCIST) 1.0: vollständiges Ansprechen mit Verschwinden aller Ziel- und PSMA-aviden Läsionen oder partielles Ansprechen mit einer mindestens 30%igen Abnahme der Summe des längsten Durchmessers und
    Abnahme des summierten SUV-Mittelwerts oder des Gesamttumorvolumens von ≥30 % der Zielläsionen gegenüber dem Ausgangswert Bilder von [68Ga]Ga-PSMA-11 nach PSMA-RLT.
    - Rate des vollständigen PSA-Ansprechens, definiert als PSA <0,2ng/ml nach radikaler Prostatektomie, und PSA-Progressionsüberleben
    definiert als PSA-Anstieg auf >50% über den Nadir oder Verabreichung von Sekundärtherapien.
    - Therapiefreies Überleben nach 2. PSMA-RLT und radikaler Prostatektomie, definiert als Zeit (Monate) von der radikalen Prostatektomie bis zur ersten PCa-gezielten Salvage-Strahlentherapie, wie z. B. systemische Zweitlinientherapie und/oder Salvage-Strahlentherapie.
    - AFS nach 2. PSMA-RLT und RP, definiert als Zeit (Monate) von der radikalen Prostatektomie bis zur ersten Verabreichung einer ADT Therapie
    - Zeit von der radikalen Prostatektomie bis zum kastrationsresistenten Prostatakrebs (gemäß den EAU-Kriterien [5])
    - Pathologisches Ansprechen bei radikaler Prostatektomie, gemessen als Raten von pathologischem Komplettansprechen, minimaler Restkrankheit
    Krankheit (≤5mm), pT3-Krankheit, positive chirurgische Ränder und Lymphknotenmetastasen.
    - Molekulare Veränderungen, die in Flüssigmarkern und Gewebeproben nach PSMA-RLT und radikaler Prostatektomie gemessen wurden
    - Quantifizierung der ctDNA und Auszählung der zikulierenden Tumorzellen
    - Bestimmung der Lebensqualität der Patienten nach der systemischen PSMA-RLT anhand von Fragebögen:
    Fragebogen der Europäischen Organisation für Forschung und Behandlung von Krebs zur Lebensqualität
    (EORTC QLQ) und Functional Assessment of Chronic Illness Therapy (FACT-P).
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 2 years
    Nach 2 Jahren
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Prospektive, einzentrige Phase-II-Studie
    Prospective single-center phase II 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
    • PSA rise (at least week apart) leading to increase >30% from baseline 4 weeks after the last
    radioligand therapy cycle.
    • Pre-operative imaging progression considered as appearance of new PSMA-avid lesions and/or progression of the size of primary tumor and lymph nodes based on RECIST criteria (v1.1).
    • Severe therapeutic toxicities as assessed by CTCAE (v5.0) at any time point.
    - PSA-Anstieg (im Abstand von mindestens einer Woche), der 4 Wochen nach dem letzten Radioliganden-Therapiezyklus zu einem Anstieg von mehr als 30 % gegenüber dem Ausgangswert führt Radioliganden-Therapiezyklus.
    - Progression in der präoperativen Bildgebung: Auftreten neuer PSMA-avider Läsionen und/oder Vergrößerung des Primärtumors und der Lymphknoten nach den RECIST-Kriterien (v1.1).
    - Schwere therapeutische Toxizitäten gemäß CTCAE (v5.0) zu einem beliebigen Zeitpunkt.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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: 5
    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 state10
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 10
    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)
    Treatment after end of study will be provided by the treating physician according to the current guidelines
    Die Behandlung nach Abschluss der Studie erfolgt durch den behandelnden Arzt gemäß den geltenden Leitlinien
    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 Decision2023-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-11-14
    P. End of Trial
    P.End of Trial StatusOngoing
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