A Registry to Observe the Treatment of Prostate Cancer Under Routine Medical Care
7. november 2019 opdateret af: Janssen Pharmaceutica N.V., Belgium
A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer
The purpose of this registry is to document the characteristics and management of patients with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice, independent of treatment used.
Given the rapidly evolving landscape in mCRPC treatments, there is a need for a current and improved understanding of how these treatments fit into the current treatment paradigm for mCRPC, how they are combined and sequenced, and how their relative effectiveness profiles emerge outside of a clinical trial setting.
This will be based on documentation and description of sequencing of treatment initiation, termination, and duration; relative effectiveness of treatments; defined medical resource utilization (MRU) and quality-of-life parameters and follow-up for survival.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
This is a non-interventional, multicenter, prospective registry of patients with a confirmed diagnosis of adenocarcinoma of the prostate presenting with mCRPC, based on documented metastatic prostate cancer and documented castration resistance.
Castrate-resistant prostate cancer is defined by disease progression despite testosterone <50 ng/dL, and/or androgen deprivation therapy, and/or a history of orchiectomy, and may present as a continuous rise in prostate-specific antigen (PSA), and/or worsening of existing disease/symptoms, and/or the appearance of new metastases.
Observational methodology will be used to capture data.
The decision of patients to take part in the registry will not influence their medical care.
Treatment decisions will be made at the discretion of the treating physician, per routine clinical practice.
Only data available from routine clinical practice will be collected.
It is expected that approximately 3,000 patients will participate in this registry.
To ensure a patient population representative of clinical practice and to reduce selection bias, all patients meeting the eligibility criteria at a participating site should be consecutively enrolled in the registry, irrespective of their treatment.
The planned total duration of the registry will be 5.5 years from the date that the first patient is enrolled, irrespective of the country or registry site.
The anticipated duration of patient enrollment is 2.5 years.
The maximum duration of follow-up for individual patients in the observational period of the registry will be 3 years, regardless of when they are enrolled.
The 3-year period of the observational period will document the sequencing of systemic mCRPC treatments during routine clinical practice, considering the life expectancy of patients with mCRPC in the registry.
Unless specified otherwise per local regulations, all patients must give their informed consent to participate in this registry before data collection (ie, data entry into the case report form [CRF]) is performed.
Patients will be enrolled at the time of initiation of a new systemic mCRPC treatment or during a period when a patient is considered to be in surveillance according to clinical practice.
Baseline data collection will include details of the patient's prostate cancer history and prior prostate cancer treatment.
This will be followed by a prospective observational period during which patients may cycle through multiple systemic mCRPC treatment periods and periods of surveillance.
During the observational period, data will be collected at the following time points of a patient's course of treatment in routine clinical practice: initiation of a new systemic mCRPC treatment; termination of a systemic mCRPC treatment; when the duration of a systemic mCRPC treatment or surveillance period is >3 months, data collection will be performed at a minimum frequency of 3-monthly intervals during that period.
Survival data will be collected for all patients 3 years after their enrollment or at the close of the registry, whichever occurs first, except for those patients who withdraw their consent prior to completing the observation period.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
3050
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Aalst, Belgien
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Antwerpen, Belgien
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Bonheiden, Belgien
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Brasschaat, Belgien
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Brugge, Belgien
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Edegem, Belgien
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Gent, Belgien
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Kortrijk, Belgien
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Liège, Belgien
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Oostende, Belgien
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Ottignies, Belgien
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Roeselare, Belgien
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Turnhout, Belgien
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Ekaterinbourg, Den Russiske Føderation
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Moscow N/a, Den Russiske Føderation
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Obninsk, Den Russiske Føderation
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Omsk, Den Russiske Føderation
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Rostov-on-Don, Den Russiske Føderation
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St.-Petersburg, Den Russiske Føderation
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Ufa, Den Russiske Føderation
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Ashton Under Lyne, Det Forenede Kongerige
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Barnstaple, Det Forenede Kongerige
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Blackburn, Det Forenede Kongerige
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Bournemouth, Det Forenede Kongerige
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Bradford, Det Forenede Kongerige
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Brighton Sussex, Det Forenede Kongerige
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Burton, Det Forenede Kongerige
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Crewe, Det Forenede Kongerige
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Huddersfield, Det Forenede Kongerige
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Lancaster, Det Forenede Kongerige
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Leeds Yorks, Det Forenede Kongerige
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London, Det Forenede Kongerige
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N/a N/a, Det Forenede Kongerige
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Plymouth, Det Forenede Kongerige
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Scunthorpe, Det Forenede Kongerige
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Steeton, Det Forenede Kongerige
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Stoke On Trent, Det Forenede Kongerige
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Taunton, Det Forenede Kongerige
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Torquay, Det Forenede Kongerige
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Wakefield, Det Forenede Kongerige
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Wigan, Det Forenede Kongerige
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York, Det Forenede Kongerige
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Angers, Frankrig
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Avignon Cedex 9, Frankrig
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Brest, Frankrig
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Béziers, Frankrig
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GAP, Frankrig
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Hyeres, Frankrig
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La Tronche, Frankrig
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Marseille, Frankrig
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Metz, Frankrig
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Montpellier, Frankrig
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Nancy, Frankrig
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Paris, Frankrig
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Perigueux, Frankrig
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Pierre Benite Cedex, Frankrig
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Pringy, Frankrig
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Reims Cedex, Frankrig
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Rennes cedex 09, Frankrig
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Saint Mande, Frankrig
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St Gregoire Cedex, Frankrig
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St Quentin Cedex, Frankrig
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Toulouse, Frankrig
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Tours Cedex, Frankrig
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Beer Sheva, Israel
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Beer Yaakov, Israel
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Haifa, Israel
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Holon, Israel
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Tel-Aviv, Israel
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Ankara, Kalkun
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Edirne, Kalkun
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Istanbul, Kalkun
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Izmir, Kalkun
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Kayseri, Kalkun
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Kocaeli, Kalkun
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Turkey, Kalkun
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Luxembourg, Luxembourg
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Niederkorn, Luxembourg
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Bydgoszcz, Polen
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Gdynia, Polen
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Krakow, Polen
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Lodz, Polen
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Opole, Polen
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Poznañ, Polen
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Warsaw, Polen
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Warszawa, Polen
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Braga, Portugal
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Coimbra, Portugal
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Evora, Portugal
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Lisboa, Portugal
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Porto, Portugal
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Setubal, Portugal
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Aarau, Schweiz
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Winterthur, Schweiz
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Celje, Slovenien
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Ljubljana, Slovenien
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Slovenj Gradec, Slovenien
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Asturias, Spanien
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Barakaldo Vizcaya, Spanien
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Barcelona, Spanien
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Bilbao Vizcaya, Spanien
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Girona, Spanien
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La Coruña, Spanien
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Langreo, Spanien
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Palma De Mallorca, Spanien
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Pontevedra, Spanien
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Sabadell, Spanien
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Salamanca, Spanien
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Santiago de Compostela, Spanien
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Valladolid, Spanien
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Zaragoza, Spanien
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Borås, Sverige
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Göteborg, Sverige
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Malmö, Sverige
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Stockholm, Sverige
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Umeå, Sverige
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Västerås, Sverige
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Växjö, Sverige
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Örebro, Sverige
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Östersund, Sverige
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Augsburg, Tyskland
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Bad Saarow, Tyskland
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Bautzen, Tyskland
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Berlin, Tyskland
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Braunschweig, Tyskland
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Chemnitz, Tyskland
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Duisburg, Tyskland
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Erkrath, Tyskland
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Frankfurt, Tyskland
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Hamburg, Tyskland
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Holzminden, Tyskland
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Jena, Tyskland
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Kiel, Tyskland
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Kirchheim, Tyskland
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Nürtingen, Tyskland
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Remscheid, Tyskland
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Reutlingen, Tyskland
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Rostock, Tyskland
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Schwerin, Tyskland
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Sindelfingen, Tyskland
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Tübingen, Tyskland
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Ulm, Tyskland
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Weiden, Tyskland
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Wilhelmshaven, Tyskland
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Würselen, Tyskland
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Salzburg, Østrig
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Vienna, Østrig
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Approximately 3,000 patients will be enrolled in this registry.
Patients eligible for enrollment will be men aged at least 18 years, with a confirmed diagnosis of adenocarcinoma of the prostate, with documented metastatic prostate cancer and documented castration resistance.
Patients will be enrolled at the time of initiating a new systemic anticancer mCRPC treatment or during surveillance; for the purpose of the registry, at enrollment, initiation of a new systemic mCRPC treatment is considered as ±30 days from a patient's baseline data collection.
Beskrivelse
Inclusion Criteria:
Patients with a histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate Patients with documented metastatic prostate cancer Patients with documented castration resistance Patients either: Initiating a new systemic mCRPC treatment; or considered to be in surveillance according to clinical practice Sign (or their legally-acceptable representatives must sign) a participation agreement or informed consent form (ICF), per local regulations.
Exclusion Criteria:
Any patient who is withdrawn from the registry for any reason may not re-enter the registry
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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mCRPC patients
Patients with metastatic castration-resistant prostate cancer treated according to routine clinical practice
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Sequencing of treatment initiation, termination, and duration
Tidsramme: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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During the registry all systemic mCRPC therapies, corticoids for systemic use in the context of prostate cancer treatment and local mCRPC therapies, including but not limited to urologic surgery, orthopaedic surgery, and local radiotherapy, will be documented.
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At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical Benefit
Tidsramme: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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Clinical benefit will be based on the Eastern Cooperative Oncology Group (ECOG) performance status, which measure the patient status on a scale from 0 (fully active) to 5 (dead).
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At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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Medical Resource Utilization
Tidsramme: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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Total number of days of hospitalization due to prostate cancer, or treatment of the disease, total number of visits to an emergency room due to prostate cancer, or treatment of the disease, and total number of outpatient visits due to prostate cancer, or treatment of the disease
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At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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European Quality of Life-5 Dimensions, 5 Levels Questionnaire (EQ-5D-(5L))
Tidsramme: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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The EQ-5D-5L is an instrument for measuring health status.
It consists of the descriptive system and the EQ visual Analogue scale (EQ VAS).
The descriptive system comprises the same 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression).
There are 5 levels for each dimension: no problems, slight problems, moderate problems, severe problems, and extreme problems.
The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'.
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At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P)
Tidsramme: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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The FACT-P consists of the FACT-General (FACT-G) and a prostate cancer subscale.
The FACT-G (Version 4) contains a 27-item questionnaire and is composed of 4 subscales of health-related quality-of-life: physical well-being, social/family well-being, emotional well being, and functional well-being.
The prostate cancer subscale is composed of 12 items, related to prostate-specific questions, which include sexuality, bowel/bladder function, and pain.
The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to 156; a higher score indicates better QOL
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At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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Overall Survival
Tidsramme: At treatment initiation/termination or every 3 months from baseline to 3 years
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At treatment initiation/termination or every 3 months from baseline to 3 years
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Radiologic Assessment
Tidsramme: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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Radiologic assessment methodology and radiologic response will be documented.
Prostate Cancer Working Group 2 (PCWG2) and Response Evaluation Criteria In Solid Tumor (RECIST) are recommended guidelines for assessment.
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At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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Prior prostate cancer treatment
Tidsramme: At baseline
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Prior prostate cancer treatment (local and systemic therapy) from the time of diagnosis of prostate cancer to entry in the registry will be recorded.
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At baseline
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Reason for start and rationale for choice of treatment
Tidsramme: At treatment initiation during maximum 3 years
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At treatment initiation during maximum 3 years
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Reason for treatment discontinuation
Tidsramme: At treatment discontinuation during maximum 3 years
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At treatment discontinuation during maximum 3 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Verry C, Vincendeau S, Massetti M, Blachier M, Vimont A, Bazil ML, Bernardini P, Pettre S, Timsit MO. Pattern of Clinical Progression Until Metastatic Castration-Resistant Prostate Cancer: An Epidemiological Study from the European Prostate Cancer Registry. Target Oncol. 2022 Jul;17(4):441-451. doi: 10.1007/s11523-022-00899-6. Epub 2022 Jul 16.
- Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaeth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L, Chowdhury S. Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry. Target Oncol. 2021 May;16(3):357-367. doi: 10.1007/s11523-021-00807-4. Epub 2021 Apr 7.
- Chowdhury S, Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaeth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L. Real-World Outcomes in First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer: The Prostate Cancer Registry. Target Oncol. 2020 Jun;15(3):301-315. doi: 10.1007/s11523-020-00720-2.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. juni 2013
Primær færdiggørelse (Faktiske)
21. november 2018
Studieafslutning (Faktiske)
21. november 2018
Datoer for studieregistrering
Først indsendt
8. september 2014
Først indsendt, der opfyldte QC-kriterier
9. september 2014
Først opslået (Skøn)
10. september 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. november 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. november 2019
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR100857
- 212082PCR4001 (Anden identifikator: Janssen Pharmaceutica NV - CTMS ID)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .