Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 805
- 试验地点
- 80
- 主要终点
- Occurrence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The purpose of this study is to find out in the real-world setting, if darolutamide is safe and effective for patients diagnosed with prostate cancer that has not spread to other parts of the body. When a patient is enrolled to the study, his/her physician would have already made the decision to treat patient with darolutamide per local standard practice.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men over the age of 18 years
- •Histologically or cytologically confirmed adenocarcinoma CRPC defined by disease progression despite ADT and may present as a confirmed rise in serum PSA levels (as defined by PCWG3: Rising PSA values at a minimum of 1-week intervals, and a baseline PSA value ≥ 1.0 ng/mL). For patients with a prior ARi treatment (Enzalutamide or Apalutamide), there is no baseline PSA value required
- •No evidence of metastasis based on conventional imaging. An imaging assessment needs to be obtained prior to the 1st dose of darolutamide. For patients with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC, M0 status with no evidence of disease progression should be confirmed within 3 months of ARi discontinuation
- •Decision to initiate treatment with darolutamide was made as per investigator's routine treatment practice prior to enrollment in the study
- •Signed informed consent
- •Life expectancy of ≥3 months
- •For a patient with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC for less than one year, all toxic effects from prior use of any ARi treatment have to be resolved at the time of enrollment and prior to the 1st dose of darolutamide
排除标准
- •Participation in an investigational program with interventions outside of routine clinical practice
- •Contraindications according to the local marketing authorization
- •Previous treatment with darolutamide (more than 3 days prior to enrollment)
- •Patient with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC for more than one year
研究组 & 干预措施
Men with nmCRPC
Men with nmCRPC for whom a decision to treat with darolutamide has been made before enrollment, and who have signed informed consent, will be eligible for the study.
干预措施: Darolutamide(Nubeqa, BAY1841788) (Drug)
结局指标
主要结局
Occurrence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 30 days after last dose of darolutamide within the patient's observation period
Including severity, seriousness and outcome.
Reasonable causal relationship between darolutamide and an adverse event (AE)
时间窗: Up to 30 days after last dose of darolutamide within the patient's observation period
Action taken related to darolutamide treatment
时间窗: Up to 30 days after last dose of darolutamide within the patient's observation period
Dose modifications and time periods
次要结局
- Prior and post - darolutamide treatments for prostate cancer(Up to 7 years)
- Subject's demographics(Up to 7 years)
- Subject's characteristics(Up to 7 years)
- Co-morbidities(Up to 7 years)
- Disease course and progression (including performance status)(Up to 7 years)
- Concomitant medication/treatment (including opioids)(Up to 7 years)
- Dosage and dose modification of darolutamide(Up to 7 years)
- Reasons for ending treatment and/or observation/follow-up(Up to 7 years)
- Metastasis-Free Survival (MFS)(Up to 7 years)
- Time to Symptomatic Skeletal Event (TSSE)(Up to 7 years)
- Time to Prostate-Specific Antigen (PSA) progression(Up to 7 years)
- Survival rate(Up to 7 years)
- Duration of darolutamide therapy(Up to 7 years)
- Imaging exams used to define tumor status(Up to 7 years)
- Imaging exams (as chosen by treating physician) used to diagnose nmCRPC (including date and clinical finding)(Up to 7 years)