Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Für die richtige Behandlungsplanung und die Prognoseerstellung eines neu diagnostizierten Prostatakrebspatienten sind Informationen über mögliche Tochtergeschwulste in den Lymphknoten sehr wichtig. Die bisher verwendeten Techniken der Computertomographie (CT) und der Magnetresonanztomographie (MRT) sind nicht genau genug, um zwischen mit Tochtergeschwülsten befallenen Lymphknoten und nicht-befallenen Lymphknoten zu unterscheiden. Das in dieser Studie verwendete Kontrastmittel (Ferrotran) ist das erste für Lymphknoten spezifische MRT-Kontrastmittel. Ein Kontrastmittel ist ein Stoff der vor der MRT- bzw. CT-Untersuchung injiziert wird und auf dem späteren Untersuchungsbild in Kontrast zu dem zu untersuchenden Gewebe erscheint.
Ziel dieser Studie ist es, die Sicherheit und die diagnostische Genauigkeit von Ferrotran zu beurteilen, das in MRT-Untersuchungen zum Nachweis von Tochtergeschwülsten der Beckenlymphknoten verwendet wird. Darüber hinaus werden die aus dieser Studie gewonnenen Daten für die Beantragung der Marktzulassung für Ferrotran verwendet.
Malattie studiate(Fonte di dati: BASEC)
Prostatakrebs
Health conditions
(Fonte di dati: WHO)
newly-diagnosed prostate cancer (PCA)
MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
In dieser Studie wird die Sicherheit und die diagnostische Genauigkeit von Ferrotran beurteilt.
Der Patient durchläuft zunächst eine Voruntersuchungs-Phase (auch „Screening“ genannt), in der Untersuchungen zur genauen Überprüfung des Gesundheitszustandes und der medizinischen Eignung des Patienten für diese Studie stattfindet. Diese Untersuchungen finden innerhalb von 28 Tagen vor dem Start der Behandlungsphase statt.
Sobald feststeht, dass der Patient an der Studie teilnehmen kann, erhält der Patient an Tag 0, das in der Studie zu untersuchende Kontrastmittel Ferrotran. Während der Behandlungsphase (Tag 0 & Tag 1) werden Untersuchungen (z.B. Blut- und Urin, Vitalzeichen (Blutdruck, Puls, etc.), EKG, Tumoruntersuchungen mittels Bildgebung) durchgeführt. Bei der Nachbeobachtungs-Visite an Tag 7 (auch „Follow-up“ genannt) werden ebenfalls studienspezifische Untersuchungen (z.B. Blut- und Urin, Vitalzeichen (Blutdruck, Puls, etc.), EKG) durchgeführt. Die geplante prostataspezifische Operation (Entfernung der Prostata mit erweiterter Entfernung der Lymphknoten im Beckenbereich) findet zwischen Tag 7 und Tag 42 statt. Zur Abschlussvisite (auch „End-of-Study-visit“ genannt), welche 7 bis 9 Wochen nach Studieneinschluss durchgeführt wird, werden nochmals studienspezifische Laboruntersuchungen sowie ein MRT (Tumoruntersuchungen mittels Bildgebung) durchgeführt.
Interventions
(Fonte di dati: WHO)
Product Name: Ferumoxtran-10
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: FERUMOXTRAN-10
CAS Number: 189047-99-2
Current Sponsor code: Ferrotran?
Other descriptive name: FERUMOXTRAN-10
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 105.2-
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
An der Studie können Männer teilnehmen, bei denen Prostatakrebs neu diagnostiziert wurde und zur Behandlung eine radikale Prostataentfernung (RP) mit erweiterter Lymphknotenentfernung (ePLND) geplant ist. Die Patienten müssen mindestes 18 Jahre alt sein und einen guten Gesundheitszustand haben.
Criteri di esclusione
(Fonte di dati: BASEC)
Nicht teilnehmen können Männer, bei denen bereits im Vorfeld eine Radiotherapie des Prostatakrebses stattgefunden hat oder für die eine Radiotherapie bzw. eine systemische Therapie (Chemo-, Immuno- oder Hormontherapie) zwischen Screening und Studienende, vorgesehen ist. Ebenfalls von der Studie ausgeschlossen sind Männer, bei denen eine Kontraindikation zur Durchführung einer Magnetresonanztherapie vorliegt. Weitere Ausschlussgründe sind unter anderem bekannte allergische Reaktionen auf Ferrotran, Vorhandensein einer Leberfunktionsstörung oder gleichzeitige Teilnahme an einer anderen klinischen Studie.
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Gender:
Female: no
Male: yes
Inclusion criteria:
1)Voluntarily given and written informed consent.
2)Male =18 years of age.
3)Histologically newly-confirmed adenocarcinoma of the prostate.
4)Medium to high risk for lymph node metastasis, defined by either:
a) PSA = 10 ng/ml or
b) Gleason-Score = 7 or
c) Stage cT2b or cT2c or T3 or T4
5)Patients scheduled for radical prostatectomy (RP) with extended lymph node dissection (ePLND) between Day 7 and Day 42 after Ferrotran?-enhanced MRI.
6)Consent to practice contraception until end of study, including female partners of childbearing potential. Effective contraceptive measures include hormonal oral, injected or implanted female contraceptives, male condom, vaginal diaphragm, cervical cap, intrauterine device.
7)Preoperative PSA, clinical T-stage, primary Gleason grade, secondary Gleason grade.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
Exclusion criteria:
1)Any contraindication to MRI, as per standard criteria.
2)Any radiation therapy or systemic antiproliferative (chemo-, immuno, or hormonal) therapy for prostate cancer (Lupron, Taxotere, Casodex, Eulexin, Zoladex, etc.) prior to screening and until after post-surgery FUP MRI.
3)Known hypersensitivity to Ferrotran?or its components such as dextran.
4)Known hypersensitivity to other parenteral iron products.
5)Acute allergy including drug allergies and allergic asthma.
6)Evidence of iron overload or disturbances in the utilisation of iron (e.g., haemochromatosis, haemosiderosis, chronic haemolytic anaemia with frequent blood transfusions).
7)Presence of liver dysfunction.
8)Any other investigational medicinal product within 30 days prior to receiving study medication until end of study visit.
9)Simultaneous participation in any other clinical trial.
10)Abnormal safety laboratory values at screening or baseline that are assessed by the principal investigator as clinically relevant.
11)Patients not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders), or other vulnerable patients (e.g. under arrest).
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Altre informazioni sulla sperimentazione
Data di registrazione della sperimentazione
14 lug 2020
Inserimento del primo partecipante
11 nov 2020
Stato di reclutamento
Not Recruiting
Titolo scientifico
(Fonte di dati: WHO)
A confirmatory, prospective, open-label, single-arm, reader-blinded multi-centre phase 3 study to assess the diagnostic accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and unenhanced MRI in reference to histopathology in newly-diagnosed prostate cancer (PCA) patients, scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (ePLND) - Prostaprogress
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional clinical trial of medicinal product
Disegno della sperimentazione
(Fonte di dati: WHO)
Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: single-arm, reader-blinded If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
Fase
(Fonte di dati: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no
Punti finali primari
(Fonte di dati: WHO)
Main Objective: 1.To confirm superiority of Ferrotran?-enhanced MRI over unenhanced MRI in sensitivity to detect metastases in normal size pelvic lymph nodes in using histopathology after lymph node dissection as established reference method (Gold Standard).
2.To confirm non-inferiority of Ferrotran?-enhanced MRI compared with unenhanced MRI in specificity with a margin of 15% in using histopathology after lymph node dissection as established reference method (Gold Standard).
;Secondary Objective: 1.To confirm non-inferiority of Ferrotran?-enhanced MRI compared with unenhanced MRI in sensitivity with a margin of 15% to detect any pelvic lymph node metastases in using histopathology after lymph node dissection as established reference method (Gold Standard).
2.To evaluate the number and sites (gross- and sub-regions) of affected lymph nodes removed and not removed by ePLND comparing the unenhanced MRI at follow-up and the pre-surgery MRIs (unenhanced and Ferrotran?-enhanced).
3.To assess the clinical safety and tolerability of a single slow drip Ferrotran? infusion.
4.To assess the impact of Ferrotran?-enhanced MRI on the patient management plan.;Primary end point(s): The co-primary endpoints for this study will be the observed sensitivity and observed specificity of the Ferrotran-enhanced MRI compared with the unenhanced baseline MRI, in assessing the nodal status (metastatic / non-metastatic) of the patient with respect to the lymph nodes considered for lymphadenectomy.
Specificity and sensitivity of Ferrotran-enhanced and un-enhanced MRI will be obtained by comparison of each method to histopathology results, and not by direct comparison of the MRI methods with each other.
The patient will be considered metastatic (patientpositive) if at least one lymph node is diagnosed as metastatic in histopathology.;Timepoint(s) of evaluation of this end point: End of study visit
Punti finali secondari
(Fonte di dati: WHO)
Secondary end point(s): Secondary endpoints:
Secondary efficacy endpoints:
a) The number and regions of lymph node metastases present in the follow-up MRI in comparison to pre-surgery MRI (unenhanced and Ferrotran?-enhanced).
b) Patients with additional dissection of lymph nodes outside the defined 8 pelvic regions due to Ferrotran? uptake i.e. pre-sacral, peri-rectal, para-aortic, which are not the standard of ePLND.
The secondary efficacy endpoints will be assessed on the basis of the secondary efficacy variables as described below.
Endpoint for patient management
Impact of Ferrotran?-enhanced MRI on patient management
Endpoints for safety and tolerability
Frequency of occurrence and severity of abnormal findings in safety investigations (physical examination, vital signs, 12 lead ECG, clinical laboratory, AEs, concomitant medication) after a single slow drip Ferrotran? infusion.
The assessment of safety and tolerability endpoints will be based on secondary safety and tolerability variables as described below.
Exploratory endpoints:
Qualitative assessment of
? Vessel visibility
? Image quality
;Timepoint(s) of evaluation of this end point: Secondary efficacy endpoints: Day 1 & surgery
Endpoint for patient management: Day 1 until surgery
Endpoints for safety and tolerability: Day 1 until Day 7, Safety Follow Up & End of Study
Exploratory endpoints: Day 1
Contatto per informazioni
(Fonte di dati: WHO)
Saving Patients' Lives Medical B.V.
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
A confirmatory, prospective, open-label, single-arm, reader-blinded multi-centre phase 3 study to assess the diagnostic accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and unenhanced MRI in reference to histopathology in newly-diagnosed prostate cancer (PCA) patients, scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (ePLND)
Collegamento ai risultati nel registro primario
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Berna
Paesi di esecuzione
(Fonte di dati: WHO)
Belgium, Germany, Netherlands, Switzerland
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Dr. Volker Meyer
+49351214440
info@abx-cro.com
Contatto per informazioni generali
(Fonte di dati: WHO)
Dr. Volker Meyer
Blasewitzer Strasse 78-80
ABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H.
00493512144417
volker.meyer@abx-cro.com
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Dr. Volker Meyer
Blasewitzer Strasse 78-80
ABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H.
00493512144417
volker.meyer@abx-cro.com
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Kantonale
Ethikkommission Bern
Data di autorizzazione da parte della commissione d’etica
27.04.2020
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2019-02140
Secondary ID (Fonte di dati: WHO)
SPL-01-001
2018-004310-18-DE
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