Post-marketing Surveillance Study for Approved Darolutamide Use in Korean Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- The outcome of (serious) adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male aged ≥19 years
- •Patients with high risk nmCPRC
- •Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dL])
- •PSA doubling time < 10 months
- •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.
- •Patients for whom the decision to initiate treatment with Darolutamide as a first time was made as per investigator's routine treatment practice
- •Written informed consent from subject or legal representative; assent from subject when appropriate
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice
- •Participants with contraindication according to the locally approved prescribing information
研究组 & 干预措施
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.
干预措施: Darolutamide (Nubeqa, BAY1841788) (Drug)
结局指标
主要结局
The outcome of (serious) adverse events
时间窗: 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.
The outcome of (serious) adverse drug reactions
时间窗: 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.
Number, severity of adverse events (including SAEs)
时间窗: 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.
Number, severity of adverse drug reactions (including SADRs)
时间窗: 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.
次要结局
- Duration of Darolutamide treatment(Up to 52 weeks)
- Reasons for ending Darolutamide(Up to 52 weeks)
- Dosage and dose modification of Darolutamide(Up to 52 weeks)
- Metastasis-free survival (MFS) by nmCRPC indication(Up to 52 weeks)
- Overall survival by nmCRPC indication(Up to 52 weeks)
- Time to Castration-Resistant Prostate Cancer (CRPC) by mHSPC indication(Up to 52 weeks)
- Time to initiation of subsequent anti-cancer therapy by mHSPC indication(Up to 52 weeks)
- Time to first symptomatic skeletal event (SSE) by nmCRPC indication(Up to 52 weeks)
- Time to prostate-specific antigen (PSA) progression by nmCRPC indication(Up to 52 weeks)
- Duration of Darolutamide treatment(Up to 52 weeks)
- Reasons for ending Darolutamide(Up to 52 weeks)
- Dosage and dose modification of Darolutamide(Up to 52 weeks)
- Time to first symptomatic skeletal event (SSE) by mHSPC indication(Up to 52 weeks)
- Time to prostate-specific antigen (PSA) progression by mHSPC indication(Up to 52 weeks)
- Overall survival by mHSPC indication(Up to 52 weeks)
- Radiological progression (Soft tissue/ Bone metastasis) by mHSPC indication(Up to 52 weeks)
- Radiological Progression-Free Survival (rPFS) by mHSPC indication(Up to 52 weeks)