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    Summary
    EudraCT Number:2013-003446-16
    Sponsor's Protocol Code Number:Study-AB03
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-04-29
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-003446-16
    A.3Full title of the trial
    Intravesical Mistletoe Extract in Superficial Bladder Cancer: A phase III efficacy study (TIM)
    Eine Phase III Wirksamkeitsstudie zur intravesikalen Instillation von Mistel-Extrakt bei oberflächlichem Blasenkarzinom (TIM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study evaluates the efficacy of the therapy of Mistletoe Extract in patients with superficial bladder cancer.
    There fore the Mistletoe Extract will be administered directly into the bladder.
    Die Studie untersucht die Wirksamkeit der Therapie von Mistel-Extrakt bei Patienten mit oberflächlichem Blasenkarzinom.
    Hierfür wird der Mistel-Extrakt direkt in die Blase eingebracht.
    A.3.2Name or abbreviated title of the trial where available
    TIM
    TIM
    A.4.1Sponsor's protocol code numberStudy-AB03
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02106572
    A.5.4Other Identifiers
    Name:AUONumber:AB 40/11
    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 SponsorAbnoba GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAbnoba GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMeckEvidence
    B.5.2Functional name of contact pointHeidrun Rexer
    B.5.3 Address:
    B.5.3.1Street AddressSeestraße 11
    B.5.3.2Town/ citySchwarz
    B.5.3.3Post code17252
    B.5.3.4CountryGermany
    B.5.4Telephone number+493982779 677
    B.5.5Fax number+493982779 678
    B.5.6E-mailheidrun.rexer@meckevidence.de
    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 Yes
    D.2.1.1.1Trade name abnobaVISCUM Fraxini 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAbnoba GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameabnobaVISCUM 900
    D.3.4Pharmaceutical form Intravesical solution/solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEschenmistelkrautextrakt
    D.3.9.1CAS number 8000056-07-7
    D.3.9.3Other descriptive nameVISCUM ALBUM HERBA
    D.3.9.4EV Substance CodeSUB15703MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number675
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    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 Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeanthroposophic medicinal product
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Intravesical solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMITOMYCIN
    D.3.9.1CAS number 50-07-7
    D.3.9.4EV Substance CodeSUB09006MIG
    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
    Male and female patients aged ≥ 18 to < 80 years with a completely resected superficial bladder cancer (Stage Ta and T1 tumors) with a classification of intermediate-risk according to the EAU and without CIS and/or G3 tumors after a TURB and one immediately post-operative intravesical instillation of MMC 40 mg.
    Männliche und weibliche Patienten zwischen 18 und 80 Jahren mit kompletter Resektion eines oberflächlichen Blasenkarzinoms (Stage Ta oder T1), mit intermediärem Risiko gemäß Klassifikation der EAU (Europäische Gesellschaft für Urologie) und ohne CIS und G3-Tumoren nach TURB und einer post-operativen Frühinstillation von 40 mg MMC.
    E.1.1.1Medical condition in easily understood language
    Patients with a superficial bladder cancer which was removed via TURB and no tumors left after removal and one immediately intravesical instillation of Mitomycin C 40 mg post surgery.
    Patienten mit oberflächlichen Blasenkarzinom, das durch eine TURB entfernt wurde, ohne verbleibende Tumore nach Entfernung und mit sofortiger Frühinstillation von 40 mg Mitomycin C 40 mg nach der OP.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10005003
    E.1.2Term Bladder cancer
    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
    The primary objective of the study is to assess the efficacy of abnobaVISCUM® 900 compared with Mitomycin C (MMC) monotherapy in patients with superficial bladder carcinoma. Primary efficacy criterion will be the time to tumor recurrence.
    Das Hauptstudienziel ist die Beurteilung der Wirksamkeit von abnobaVISCUM® 900 im Vegleich zu Mitomycin C (MMC) Monotherapie bei Patienten mit obeflächlichem Blasenkarzinom. Das Hauptwirksamkeitskriterium ist die Zeit bis zum Tumorrezidiv.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to evaluate the safety of abnobaVISCUM® 900 compared to MMC monotherapy in patients with superficial bladder carcinoma, in particular, to compare the toxicity of abnobaVISCUM® 900 compared to MMC monotherapy in patients with superficial bladder carcinoma. Another secondary objective is the treatment efficacy as measured by calculated prognosis for recurrence and progression after 1 year, tumor grading and Quality of Life.
    Sekundäres Studienziel ist die Bewertung der Sicherheit von abnobaVISCUM® 900 verglichen mit MMC-Monotherapie bei Patienten mit obeflächlichem Blasenkarzinom, insbesondere der Vergleich der Toxizität von abnobaVISCUM® 900 verglichen mit MMC-Monotherapie bei Patienten mit oberflächlichem Blasenkarzinom. Ein weiteres sekundäres Studienziel ist die Wirksamkeit der Behandlung gemessen anhand der berechneten Prognose für Rezidiv und Progress nach einem Jahr, Tumorgrading und Lebensqualität.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients may be included in the study only if they meet all of the following criteria:
    1. Signed and dated written informed consent for data protection and willingness to participate and comply with the study protocol prior to any study-related procedures
    2. Male or female outpatients
    3. Aged  18 to < 80 years
    4. Completely resected (detrusor muscle in the TUR specimen has to be present) superficial bladder carcinoma (Stage Ta or T1) with classification as intermediate-risk according to the EAU (without CIS and/or G3) and one immediately post operative intravesical MMC instillation of 40 mg, completed re-resection if indicated
    5. Have a Karnofsky Performance Status of 50% to 100% (corresponding to ECOG Performance Status of 0 to 2)
    6. Have a life expectancy of ≥ 2 years at the time point of study inclusion
    7. Have normal renal and liver function, normal cardiac and hematology profiles (patients with laboratory values slightly outside the reference range may be included, unless the investigator considers the abnormality as clinically significant)
    8. Female patients of childbearing potential must have a negative pregnancy test (β-HCG test) at screening. All female patients must fulfill one of the following criteria:
    • Post-menopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle-stimulating hormone (FSH) levels in the laboratory defined post-menopausal range
    • Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
    • Sexually active women of childbearing potential must use an effective method of contraception (Pearl-Index < 1, e.g. oral contraceptives, other hormonal contraceptives [vaginal products, skin patches, or implanted or injectable products], or mechanical products such as an intrauterine device or barrier methods [diaphragm, spermicides]) from the time point of signing informed consent until 12 weeks after the last instillation
    Patienten können nur in die Studie eingeschlossen werden, wenn sie folgende Kriterien erfüllen:
    1. Unterzeichnete und datierte Einverständniserklärung
    2. Männliche oder weibliche ambulante Patienten
    3. Alter zwischen 18 und < 80 Jahren
    4. Komplett reseziertes oberflächliches Blasenkarzinom (Stage Ta oder T1) (Musculus detrusor Proben aus der TUR müssen vorliegen) mit intermediärem Risiko gemäß Klassifikation der EAU (ohne CIS und/oder G3) und einer sofortigen post-operativen Frühinstillation von 40mg MMC und mit vollständiger Nachresektion, sofern angezeigt
    5. Karnofsky Performance Status von 50 % bis 100 % (in Übereinstimmung mit dem ECOG Performance Status von 0 bis 2)
    6. Lebenserwartung von ≥ 2 Jahren ab dem Zeitpunkt des Studieneinschlusses
    7. Normale Nieren- und Leberfunktionen, normale Herz- und Hämatologie-Profile (Patienten mit Laborwerten, die gering außerhalb der Normwerte liegen, können eingeschlossen werden, außer der Prüfer betrachtet die Abweichung als klinisch relevant)
    8. Weibliche Patienten im gebärfähigen Alter müssen zum Screening einen negativen Schwangerschaftstest (β-HCG Test) haben. Alle weiblichen Patienten müssen eines der folgenden Kriterien erfüllen:
    • postmenopausale Amenorrhoe von mindestens 12 Monaten nach Einstellung aller exogenen hormonellen Behandlungen und mit einem FSH-Level im postmenopausalen Bereich
    • Dokumentation einer irreversiblen chirurgischen Sterilisation durch Hysterektomie , bilaterale Oophorektomie oder bilaterale Salpingektomie, aber keiner Tubenligatur.
    • Sexuell aktive Frauen im gebärfähigen Alter müssen vom Zeitpunkt der Unterschrift auf der Einverständniserklärung bis 12 Wochen nach der letzten Instillation eine effektive Methode der Empfängnisverhütung nutzen (Pearl-Index < 1, z.B. orale Kontrazeptiva, andere hormonelle Kontrazeptiva [Vaginalprodukte, Hautpflaster, oder implantierbare oder injizierbare Produkte], oder mechanische Produkte, wie intrauterine Mittel oder Barrieremethoden [Diaphragma, Spermizide])
    E.4Principal exclusion criteria
    Patients will not be entered in the study if they meet at least one of the following criteria:
    1. Have locally infiltrative or metastatic bladder tumor (Stage T2 or greater), low-risk or high-risk Stage Ta and T1 tumors (according to EAU classification), a bad prognosis regarding progression (CIS or G3), presence of upper urinary tract tumors or lesions which were not completely removed by TURB
    2. Have urinary tract infection, benign prostatic obstruction grade II or III, neurogenic bladder, stress incontinence, bladder or urethral diverticula, fistulas or urethral stenosis
    3. Patients with acute systemic illness, such as inflammatory infections with fever > 38°C
    4. Patients with previous recurrence of a superficial bladder cancer or radiotherapy of the bladder or other intravesical treatment within the last 6 months, or patients with previous mistletoe therapy
    5. Patients with other previous or co-existing malignancies or CIS
    6. Patients having any previous or concurrent therapy with a systemic chemo- / immunotherapeutical treatment regimen, in particular vinca alkaloids, bleomycine and doxorubicine, or patients who are treated with pyroxidine hydrochloride (vitamin B6)
    7. Untreated coagulation disorders or inadequate anticoagulation therapy
    8. Leukocyte count < 4,000/mm3 or platelet count < 100,000/mm3
    9. Serum creatinine > 1.7 mg/dL
    10. Patients with known hypersensitivity to the excipients of the study medication (monosodium phosphate, disodium phosphate, ascorbic acid)
    11. Patients with a known hypersensitivity to mistletoe products and MMC
    12. Patients who were administered within a 4-week period before Visit 1 any other experimental drug under investigation
    13. Male patients planning to father a child or sperm donation from the first administration of study medication until 3 months after the last administration of the study medication
    14. Male patients unwilling to use barrier contraception ie, condoms and spermicide, from the day of first administration of the study medication until 12 weeks after administration of the study medication
    15. Patients with a history of alcohol and / or drug abuse
    16. Patients who are unable to be regularly observed, not permitting adequate follow-up and compliance to the protocol
    Patienten werden nicht in die Studie eingeschlossen, wenn mindestens eines der folgenden Kriterien zutrifft:
    1. Patienten mit lokal infiltriertem oder metastasiertem Blasenkarzinom (Stage T2 oder höher), Stage Ta and T1 Tumoren mit geringem oder hohem Risiko (gemäß EAU Klassifikation), einer schlechten Prognose bezüglich eines Progresses (CIS or G3), Vorliegen von Tumoren des oberen Harntraktes oder von Läsionen, welche nicht vollständig durch die TURB entfernt wurden
    2. Patienten mit Harnwegsinfektion, benigner prostatischer Obstruktion Grad II oder III, neurogener Harnblase, Stressinkontinenz, Blasen- oder Urethradivertikeln, Fisteln oder Urethrastenosen
    3. Patienten mit akuter systemischer Erkrankung, wie entzündliche Infektionen mit Fieber > 38°C
    4. Patienten mit vorangegangenem Rezidiv des oberflächlichen Blasenkarzinoms oder Radiotherapie der Harnblase oder anderer intravesikaler Therapie innerhalb der letzten 6 Monate, oder Patienten mit vorangegangener Misteltherapie
    5. Patienten mit anderen vorangegangenen oder begleitenden malignen Erkrankungen oder CIS
    6. Patienten mit vorangegangener oder begleitender systemischer Chemo- oder Immunotherapie , insbesondere mit Vincaalkaloiden, Bleomycin und Doxorubicin, oder Patienten, die mit Pyroxidin Hydrochlorid (Vitamin B6) behandelt werden
    7. Unbehandelte Gerinnungsstörungen oder ungenügende Antikoagulationstherapie
    8. Leukozytenzahl < 4.000/mm3 oder Thrombozytenzahl < 100.000/mm3
    9. Serumkreatinin > 1,7 mg/dL
    10. Patienten mit bekannter Überempfindlichkeit auf die Trägerstoffe der Studienmedikation (Mononatriumphosphat, Bi-Natriumphosphat, Ascorbinsäure)
    11. Patienten mit einer bekannten Überempfindlichkeit auf Mistelpräparate und MMC
    12. Patienten, welchen innerhalb eines Zeitraumes von 4 Wochen vor Visite 1 unter Beobachtung irgendein anderes experimentelles Medikament verabreicht wurde
    13. männliche Patienten, welche die Zeugung eines Kindes oder eine Samenspende planen, von der ersten Verabreichung der Studienmedikation bis 3 Monate nach der letzten Verabreichung der Studienmedikation
    14. männliche Patienten, welche nicht bereit sind, Barrieremethoden zur Verhütung einzusetzen, d.h. Kondome und Spermizide, vom Tag der ersten Verabreichung der Studienmedikation bis 12 Wochen nach Verabreichung der Studienmedikation
    15. Patienten mit einer Vorgeschichte von Alkohol- und/oder Drogenmissbrauch
    16. Patienten, die nicht regelmäßig nachgesorgt werden können oder die einem adäquaten Follow-up und einem protokollgemäßen Verhalten nicht zustimmen
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study will be the time to tumor recurrence. Should a recurrence of the bladder carcinoma be recorded, the patient will be withdrawn from study treatment.
    Primäres Studienziel ist die Zeit bis zum Tumorrezidiv. Sollte ein Rezidiv des Blasenkarzinoms dokumentiert werden, wird der Patient von der weiteren Studienbehandlung ausgeschlossen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 48 weeks
    Bis 48 Wochen
    E.5.2Secondary end point(s)
    The secondary objective, namely safety including toxicity and tolerability of the study medication, will be assessed by the monitoring of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE), laboratory assessments (hematology, biochemistry and urinalysis) and a global judgment of tolerability. Secondary efficacy endpoints: prognosis after 1 year for recurrence and progression, estimated by the European Organization for Research and Treatment of Cancer (EORTC) Bladder Cancer Calculator, tumor grading, Quality of Life (EORTC QLQ-C30 and BLS24)
    Die sekundären Studienendpunkte, namentlich die Sicherheit inklusive Toxizität und Verträglichkeit der Studienmedikation, werden durch die Überwachung der unerwünschten Ereignisse gemäß Common Toxicity Criteria for Adverse Events (CTCAE), Laborparametern (Hämatologie, Biochemie und Urinanalyse) und einer allgemeinen Bewertung der Verträglichkeit ausgewertet. Sekundäre Endpunkte sind: Prognose für Rezidiv und Progression nach einem Jahr, geschätzt anhand des European Organization for Research and Treatment of Cancer (EORTC) Bladder Cancer Calculators, Tumorgrading und Lebensqualität (EORTC QLQ-C30 und BLS24)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 48 weeks
    Bis 48 Wochen
    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) 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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 trial2
    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 concerned32
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Egypt
    Germany
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 182
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 364
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state520
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 520
    F.4.2.2In the whole clinical trial 546
    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
    keine
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Association of Urological Oncology
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-01
    P. End of Trial
    P.End of Trial StatusOngoing
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