Um estudo observacional para aprender mais sobre a segurança da darolutamida em homens com câncer de próstata na Coreia
Estudo de vigilância pós-comercialização para uso aprovado de darolutamida em pacientes coreanos
This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels.
This study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth.
To learn more about the safety of Darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.
During this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors.
Each participant will be in this study for 1 year. The whole study will last about 6 years. During this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. At these visits, the doctors will do scans to check the patients' cancer and take blood samples. The patients will answer questions about any medications they are taking and whether they have any adverse events.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Bayer Clinical Trials Contact
- Número de telefone: 0018888422937
- E-mail: clinical-trials-contact@bayer.com
Locais de estudo
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Multiple Locations, Coréia do Sul
- Recrutamento
- Many locations
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients who have been prescribed Darolutamide for a medically appropriate use will be eligible to be enrolled.
Descrição
Inclusion Criteria:
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Male aged ≥19 years
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Patients with high risk nmCPRC
- Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dL])
- PSA doubling time < 10 months
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Patients with mHSPC
- histologically or cytologically confirmed prostate cancer, and metastases detected on bone scanning, contrast-enhanced computed tomography (CT), or magnetic resonance imaging (MRI).
- be candidates for androgen-deprivation therapy with/without docetaxel.
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Patients for whom the decision to initiate treatment with Darolutamide as a first time was made as per investigator's routine treatment practice
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Written informed consent from subject or legal representative; assent from subject when appropriate
Exclusion Criteria:
- Patients participating in an investigational program with interventions outside of routine clinical practice
- Participants with contraindication according to the locally approved prescribing information
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Male patients with nmCRPC or mHSPC
Male patients with a diagnosis of non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC) will be enrolled after the decision for treatment with Darolutamide has been made by the investigator. |
The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number, severity of adverse events (including SAEs)
Prazo: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
|
SAE stands for serious adverse event. An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment. |
From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
|
|
Number, severity of adverse drug reactions (including SADRs)
Prazo: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
|
SADR stands for serious adverse drug reaction. An ADR is any AE judged by investigator as having a reasonable suspected causal relationship to Darolutamide. |
From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
|
|
The outcome of (serious) adverse events
Prazo: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
|
An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment. |
From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
|
|
The outcome of (serious) adverse drug reactions
Prazo: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
|
An ADR is any AE judged by investigator as having a reasonable suspected causal relationship to Darolutamide. |
From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Razões para terminar a Darolutamida
Prazo: Até 52 semanas
|
Até 52 semanas
|
|
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Dosagem e modificação da dose de Darolutamida
Prazo: Até 52 semanas
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Até 52 semanas
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Metastasis-free survival (MFS) by nmCRPC indication
Prazo: Up to 52 weeks
|
MFS is defined as the time (months) from the initiation of Darolutamide treatment to the date of first observed metastasis. |
Up to 52 weeks
|
|
Time to first symptomatic skeletal event (SSE) by nmCRPC indication
Prazo: Up to 52 weeks
|
Time to SSE is defined as the time (months) from the initiation of Darolutamide treatment to the date of first diagnosed skeletal-related event. |
Up to 52 weeks
|
|
Time to prostate-specific antigen (PSA) progression by nmCRPC indication
Prazo: Up to 52 weeks
|
Time to PSA progression is defined as the time (months) from the initiation of Darolutamide treatment to the date at which PSA is recorded at ≥25% increase above the nadir (lowest screening or baseline) value along with an increase in absolute value of ≥2 ng/mL above nadir. |
Up to 52 weeks
|
|
Overall survival by nmCRPC indication
Prazo: Up to 52 weeks
|
Overall survival is defined as the time (months) from the initiation of Darolutamide treatment until death from any cause. |
Up to 52 weeks
|
|
Time to Castration-Resistant Prostate Cancer (CRPC) by mHSPC indication
Prazo: Up to 52 weeks
|
Time to mCRPC, defined as the time to PSA progression with serum testosterone being at castrate level <0.50 ng/mL, or the time to progression by soft tissue/visceral lesions or time to progression by bone lesions, whatever comes first. |
Up to 52 weeks
|
|
Time to first symptomatic skeletal event (SSE) by mHSPC indication
Prazo: Up to 52 weeks
|
Time to SSE is defined as the time (months) from the initiation of Darolutamide treatment to the date of first diagnosed skeletal-related event. |
Up to 52 weeks
|
|
Time to prostate-specific antigen (PSA) progression by mHSPC indication
Prazo: Up to 52 weeks
|
Time to PSA progression is defined as the time (months) from the initiation of Darolutamide treatment to the date at which PSA is recorded at ≥25% increase above the nadir (lowest screening or baseline) value along with an increase in absolute value of ≥2 ng/mL above nadir. |
Up to 52 weeks
|
|
Overall survival by mHSPC indication
Prazo: Up to 52 weeks
|
Overall survival is defined as the time (months) from the initiation of Darolutamide treatment until death from any cause. |
Up to 52 weeks
|
|
Time to initiation of subsequent anti-cancer therapy by mHSPC indication
Prazo: Up to 52 weeks
|
Time to initiation of subsequent anti-cancer therapy is defined as the time (months) from the initiation of Darolutamide treatment to the date of first administration of any subsequent anti-cancer therapy after discontinuation of Darolutamide. |
Up to 52 weeks
|
|
Radiological progression (Soft tissue/ Bone metastasis) by mHSPC indication
Prazo: Up to 52 weeks
|
Radiological progression is defined as the time (months) from the start of Darolutamide treatment to the date of first documentation of radiological progressive disease or death due to any cause, whichever occurs first. |
Up to 52 weeks
|
|
Radiological Progression-Free Survival (rPFS) by mHSPC indication
Prazo: Up to 52 weeks
|
Radiographic Progression-Free Survival (rPFS) is defined as the time (months) from the initiation of Darolutamide treatment to the date of the first radiologically confirmed disease progression or death from any cause, whichever occurs first. |
Up to 52 weeks
|
|
Duration of Darolutamide treatment
Prazo: Up to 52 weeks
|
Duration of Darolutamide treatment is defined as the time (months) from the start of Darolutamide treatment to the day of permanent discontinuation of Darolutamide (including death). |
Up to 52 weeks
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20654
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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