A Study on Drug-drug Interactions in Patients Treated With Anticancer Agents for a Non Metastatic Castrate-resistant Prostate Cancer or a Metastatic Castrate naïve Prostate Cancer in Real Life Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Rate of patients with a non metastatic castration-resistant or a metastatic castrate naïve prostate cancer with at least one significant drug interaction.
研究概览
简要总结
This will be a national observational, non-randomised, multicentre study, conducted in France.
Patients will be recruited in routine clinical practice by office- or hospital-based urology and/or oncology specialists when a first line treatment for their castrate resistant prostate cancer is initiated. The decision to treat patients with either agent preceding study enrolment will be left to the investigator's decision, per routine clinical practice. The nature of treatment and clinical care of patients will not be influenced by their participation in the study. All patients meeting the study criteria who visit the study physician will be consecutively invited to participate in the study to minimise recruitment bias. All medications administered will be collected. This is a non-interventional study. The investigators are free to choose products, and modalities of administration in accordance with the local Summary of Product Characteristics Therefore, the decision to prescribe one of these therapies must be made prior to and independently from the decision to enrol patients in this non interventional study.
Potential DDI will be identified using electronic screening methods (Micromedex Software and Theriaque Software).
This design will enable assessment of treatment and subsequent outcomes based on local standards, and is likely to encompass a wider range of therapeutic decisions compared with the stricter, defined limits on therapy required by investigational study protocols. Decisions and outcomes made in real-world conditions are likely to be more widely applicable to clinical practice than those from interventional studies.
Following French regulation there is no need for an approval of ethic committee for this type of observational study.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Rate of patients with a non metastatic castration-resistant or a metastatic castrate naïve prostate cancer with at least one significant drug interaction.
时间窗: 18 months
次要结局
- Description of the rate of patients with prostate cancer presenting a significant comorbidity according to investigator in a real life setting(18 months)
- Total number of drug interactions per patient(18 months)
- Exploratory assessment of baseline clinical (e.g. age, comorbidities, stage of cancer, ECOG) or biological (e.g. CBC, liver tests, PSA, albumin) parameters that may be link to a higher risk of drug interaction(18 months)
