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A Registry to Observe the Treatment of Prostate Cancer Under Routine Medical Care

7 novembre 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Cancer de la prostate

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

3050

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Allemagne
- - Augsburg, Allemagne
  - Bad Saarow, Allemagne
  - Bautzen, Allemagne
  - Berlin, Allemagne
  - Braunschweig, Allemagne
  - Chemnitz, Allemagne
  - Duisburg, Allemagne
  - Erkrath, Allemagne
  - Frankfurt, Allemagne
  - Hamburg, Allemagne
  - Holzminden, Allemagne
  - Jena, Allemagne
  - Kiel, Allemagne
  - Kirchheim, Allemagne
  - Nürtingen, Allemagne
  - Remscheid, Allemagne
  - Reutlingen, Allemagne
  - Rostock, Allemagne
  - Schwerin, Allemagne
  - Sindelfingen, Allemagne
  - Tübingen, Allemagne
  - Ulm, Allemagne
  - Weiden, Allemagne
  - Wilhelmshaven, Allemagne
  - Würselen, Allemagne
Belgique
- - Aalst, Belgique
  - Antwerpen, Belgique
  - Bonheiden, Belgique
  - Brasschaat, Belgique
  - Brugge, Belgique
  - Edegem, Belgique
  - Gent, Belgique
  - Kortrijk, Belgique
  - Liège, Belgique
  - Oostende, Belgique
  - Ottignies, Belgique
  - Roeselare, Belgique
  - Turnhout, Belgique
Espagne
- - Asturias, Espagne
  - Barakaldo Vizcaya, Espagne
  - Barcelona, Espagne
  - Bilbao Vizcaya, Espagne
  - Girona, Espagne
  - La Coruña, Espagne
  - Langreo, Espagne
  - Palma De Mallorca, Espagne
  - Pontevedra, Espagne
  - Sabadell, Espagne
  - Salamanca, Espagne
  - Santiago de Compostela, Espagne
  - Valladolid, Espagne
  - Zaragoza, Espagne
France
- - Angers, France
  - Avignon Cedex 9, France
  - Brest, France
  - Béziers, France
  - GAP, France
  - Hyeres, France
  - La Tronche, France
  - Marseille, France
  - Metz, France
  - Montpellier, France
  - Nancy, France
  - Paris, France
  - Perigueux, France
  - Pierre Benite Cedex, France
  - Pringy, France
  - Reims Cedex, France
  - Rennes cedex 09, France
  - Saint Mande, France
  - St Gregoire Cedex, France
  - St Quentin Cedex, France
  - Toulouse, France
  - Tours Cedex, France
Fédération Russe
- - Ekaterinbourg, Fédération Russe
  - Moscow N/a, Fédération Russe
  - Obninsk, Fédération Russe
  - Omsk, Fédération Russe
  - Rostov-on-Don, Fédération Russe
  - St.-Petersburg, Fédération Russe
  - Ufa, Fédération Russe
Israël
- - Beer Sheva, Israël
  - Beer Yaakov, Israël
  - Haifa, Israël
  - Holon, Israël
  - Tel-Aviv, Israël
L'Autriche
- - Salzburg, L'Autriche
  - Vienna, L'Autriche
Le Portugal
- - Braga, Le Portugal
  - Coimbra, Le Portugal
  - Evora, Le Portugal
  - Lisboa, Le Portugal
  - Porto, Le Portugal
  - Setubal, Le Portugal
Luxembourg
- - Luxembourg, Luxembourg
  - Niederkorn, Luxembourg
Pologne
- - Bydgoszcz, Pologne
  - Gdynia, Pologne
  - Krakow, Pologne
  - Lodz, Pologne
  - Opole, Pologne
  - Poznañ, Pologne
  - Warsaw, Pologne
  - Warszawa, Pologne
Royaume-Uni
- - Ashton Under Lyne, Royaume-Uni
  - Barnstaple, Royaume-Uni
  - Blackburn, Royaume-Uni
  - Bournemouth, Royaume-Uni
  - Bradford, Royaume-Uni
  - Brighton Sussex, Royaume-Uni
  - Burton, Royaume-Uni
  - Crewe, Royaume-Uni
  - Huddersfield, Royaume-Uni
  - Lancaster, Royaume-Uni
  - Leeds Yorks, Royaume-Uni
  - London, Royaume-Uni
  - N/a N/a, Royaume-Uni
  - Plymouth, Royaume-Uni
  - Scunthorpe, Royaume-Uni
  - Steeton, Royaume-Uni
  - Stoke On Trent, Royaume-Uni
  - Taunton, Royaume-Uni
  - Torquay, Royaume-Uni
  - Wakefield, Royaume-Uni
  - Wigan, Royaume-Uni
  - York, Royaume-Uni
Slovénie
- - Celje, Slovénie
  - Ljubljana, Slovénie
  - Slovenj Gradec, Slovénie
Suisse
- - Aarau, Suisse
  - Winterthur, Suisse
Suède
- - Borås, Suède
  - Göteborg, Suède
  - Malmö, Suède
  - Stockholm, Suède
  - Umeå, Suède
  - Västerås, Suède
  - Växjö, Suède
  - Örebro, Suède
  - Östersund, Suède
Turquie
- - Ankara, Turquie
  - Edirne, Turquie
  - Istanbul, Turquie
  - Izmir, Turquie
  - Kayseri, Turquie
  - Kocaeli, Turquie
  - Turkey, Turquie

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
mCRPC patients Patients with metastatic castration-resistant prostate cancer treated according to routine clinical practice

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Sequencing of treatment initiation, termination, and duration Délai: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	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.	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Clinical Benefit Délai: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	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).	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Medical Resource Utilization Délai: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	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	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
European Quality of Life-5 Dimensions, 5 Levels Questionnaire (EQ-5D-(5L)) Délai: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	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'.	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) Délai: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	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	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Overall Survival Délai: At treatment initiation/termination or every 3 months from baseline to 3 years		At treatment initiation/termination or every 3 months from baseline to 3 years
Radiologic Assessment Délai: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	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.	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Prior prostate cancer treatment Délai: At baseline	Prior prostate cancer treatment (local and systemic therapy) from the time of diagnosis of prostate cancer to entry in the registry will be recorded.	At baseline
Reason for start and rationale for choice of treatment Délai: At treatment initiation during maximum 3 years		At treatment initiation during maximum 3 years
Reason for treatment discontinuation Délai: At treatment discontinuation during maximum 3 years		At treatment discontinuation during maximum 3 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Janssen Pharmaceutica N.V., Belgium

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

14 juin 2013

Achèvement primaire (Réel)

21 novembre 2018

Achèvement de l'étude (Réel)

21 novembre 2018

Dates d'inscription aux études

Première soumission

8 septembre 2014

Première soumission répondant aux critères de contrôle qualité

9 septembre 2014

Première publication (Estimation)

10 septembre 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 novembre 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 novembre 2019

Dernière vérification

1 novembre 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

CR100857
212082PCR4001 (Autre identifiant: Janssen Pharmaceutica NV - CTMS ID)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .