Special Investigation of TALZENNA Capsules - Study on BRCA Mutation-Positive Metastatic Castration-Resistant Prostate Cancer -
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Incidence of adverse drug reactions
研究概览
简要总结
The purpose of this study is to learn about the safety of TALZENNA in patients with BRCA mutation-positive metastatic castration-resistant prostate cancer. BRCA mutation positive means any changes to the BRCA gene. Metastasis means the cancer that has spread to other parts of the body. Castration-resistant prostate cancer means the prostate cancer that keeps growing even when the amount of male sex hormone in the body is reduced to very low levels. Prostate is a male sex organ.
The study is seeking for participants:
- with BRCA mutation-positive metastatic castration-resistant prostate cancer
- who have not used this study medicine before. All patients in this study will receive TALZENNA according to the prescriptions.
Patients will be followed up to 52 weeks (12 months) from the day of start of treatment start (Day 1). However, in cases where treatment has been completed or stopped less than 52 weeks (12 months) after the start of giving study medicine, the participants will be checked until completion (discontinuation) of treatment.
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
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with BRCA mutation-positive metastatic castration-resistant prostate cancer
- •No history of previous use of this drug
排除标准
- 未提供
结局指标
主要结局
Incidence of adverse drug reactions
时间窗: Up to 52 weeks
For adverse drug reactions corresponding to myelosuppression, interstitial lung disease, thromboembolism, and secondary malignant tumour, the incidence, time of onset, grade, outcome etc. will be tabulated.
次要结局
未报告次要终点