Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

7 de noviembre de 2019 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

3050

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Masculino

Método de muestreo

Muestra de probabilidad

Población de estudio

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.

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sequencing of treatment initiation, termination, and duration
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical Benefit
Periodo de tiempo: 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
Periodo de tiempo: 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))
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: At treatment initiation during maximum 3 years
At treatment initiation during maximum 3 years
Reason for treatment discontinuation
Periodo de tiempo: At treatment discontinuation during maximum 3 years
At treatment discontinuation during maximum 3 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Janssen Pharmaceutica N.V., Belgium

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

14 de junio de 2013

Finalización primaria (Actual)

21 de noviembre de 2018

Finalización del estudio (Actual)

21 de noviembre de 2018

Fechas de registro del estudio

Enviado por primera vez

8 de septiembre de 2014

Primero enviado que cumplió con los criterios de control de calidad

9 de septiembre de 2014

Publicado por primera vez (Estimar)

10 de septiembre de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de noviembre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

7 de noviembre de 2019

Última verificación

1 de noviembre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CR100857
  • 212082PCR4001 (Otro identificador: Janssen Pharmaceutica NV - CTMS ID)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Cancer de prostata

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Macedonia

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

Suscribir