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

7 de novembro de 2019 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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 estudo

Observacional

Inscrição (Real)

3050

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Augsburg, Alemanha
      • Bad Saarow, Alemanha
      • Bautzen, Alemanha
      • Berlin, Alemanha
      • Braunschweig, Alemanha
      • Chemnitz, Alemanha
      • Duisburg, Alemanha
      • Erkrath, Alemanha
      • Frankfurt, Alemanha
      • Hamburg, Alemanha
      • Holzminden, Alemanha
      • Jena, Alemanha
      • Kiel, Alemanha
      • Kirchheim, Alemanha
      • Nürtingen, Alemanha
      • Remscheid, Alemanha
      • Reutlingen, Alemanha
      • Rostock, Alemanha
      • Schwerin, Alemanha
      • Sindelfingen, Alemanha
      • Tübingen, Alemanha
      • Ulm, Alemanha
      • Weiden, Alemanha
      • Wilhelmshaven, Alemanha
      • Würselen, Alemanha
  • 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
  • Eslovênia
      • Celje, Eslovênia
      • Ljubljana, Eslovênia
      • Slovenj Gradec, Eslovênia
  • Espanha
      • Asturias, Espanha
      • Barakaldo Vizcaya, Espanha
      • Barcelona, Espanha
      • Bilbao Vizcaya, Espanha
      • Girona, Espanha
      • La Coruña, Espanha
      • Langreo, Espanha
      • Palma De Mallorca, Espanha
      • Pontevedra, Espanha
      • Sabadell, Espanha
      • Salamanca, Espanha
      • Santiago de Compostela, Espanha
      • Valladolid, Espanha
      • Zaragoza, Espanha
  • Federação Russa
      • Ekaterinbourg, Federação Russa
      • Moscow N/a, Federação Russa
      • Obninsk, Federação Russa
      • Omsk, Federação Russa
      • Rostov-on-Don, Federação Russa
      • St.-Petersburg, Federação Russa
      • Ufa, Federação Russa
  • França
      • Angers, França
      • Avignon Cedex 9, França
      • Brest, França
      • Béziers, França
      • GAP, França
      • Hyeres, França
      • La Tronche, França
      • Marseille, França
      • Metz, França
      • Montpellier, França
      • Nancy, França
      • Paris, França
      • Perigueux, França
      • Pierre Benite Cedex, França
      • Pringy, França
      • Reims Cedex, França
      • Rennes cedex 09, França
      • Saint Mande, França
      • St Gregoire Cedex, França
      • St Quentin Cedex, França
      • Toulouse, França
      • Tours Cedex, França
  • Israel
      • Beer Sheva, Israel
      • Beer Yaakov, Israel
      • Haifa, Israel
      • Holon, Israel
      • Tel-Aviv, Israel
  • Luxemburgo
      • Luxembourg, Luxemburgo
      • Niederkorn, Luxemburgo
  • Peru
      • Ankara, Peru
      • Edirne, Peru
      • Istanbul, Peru
      • Izmir, Peru
      • Kayseri, Peru
      • Kocaeli, Peru
      • Turkey, Peru
  • Polônia
      • Bydgoszcz, Polônia
      • Gdynia, Polônia
      • Krakow, Polônia
      • Lodz, Polônia
      • Opole, Polônia
      • Poznañ, Polônia
      • Warsaw, Polônia
      • Warszawa, Polônia
  • 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
  • Suécia
      • Borås, Suécia
      • Göteborg, Suécia
      • Malmö, Suécia
      • Stockholm, Suécia
      • Umeå, Suécia
      • Västerås, Suécia
      • Växjö, Suécia
      • Örebro, Suécia
      • Östersund, Suécia
  • Suíça
      • Aarau, Suíça
      • Winterthur, Suíça
  • Áustria
      • Salzburg, Áustria
      • Vienna, Áustria

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Macho

Método de amostragem

Amostra de Probabilidade

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Sequencing of treatment initiation, termination, and duration
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Clinical Benefit
Prazo: 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
Prazo: 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))
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: At treatment initiation during maximum 3 years
At treatment initiation during maximum 3 years
Reason for treatment discontinuation
Prazo: At treatment discontinuation during maximum 3 years
At treatment discontinuation during maximum 3 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Janssen Pharmaceutica N.V., Belgium

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

14 de junho de 2013

Conclusão Primária (Real)

21 de novembro de 2018

Conclusão do estudo (Real)

21 de novembro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

8 de setembro de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de setembro de 2014

Primeira postagem (Estimativa)

10 de setembro de 2014

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de novembro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de novembro de 2019

Última verificação

1 de novembro de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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