Treatment Patterns in Metastatic Castration-Resistance Prostate Cancer (mCRPC): Real Life Analysis In Brazilian Oncology Centers (REALIST-PRO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 382
- 主要终点
- Percentage of Participants Treated With Chemotherapy in First Line Therapy
研究概览
简要总结
The purpose of this study is to assess the treatment patterns in participants with metastatic castration-resistant prostate cancer (mCRPC). Additionally, participant's demographic and clinical characteristics, skeletal-related events, criteria used to define CRPC, prostate specific antigen (PSA) levels and pain related to disease and overall survival will be observed.
详细描述
This is an observational (study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes), longitudinal (correlational research study that involves repeated observations of the same variables over long periods of time) and retrospective (study looking back over past experience) study to describe the treatment patterns in mCRPC. Treatment patterns will be assessed by collecting medical charts from participants diagnosed with mCRPC in or prior 2009. Primarily, percentage of participants who received therapy as first line treatment will be assessed. All adverse events associated with the use of Sponsor drugs will be reported.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Report of previous surgical or medical castration
- •Castration-resistant prostate cancer (CRPC) diagnosis in or before 2009
- •Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography or magnetic resonance imaging in or before
- •If lymph node metastasis is the only evidence of metastasis, it must be 2 centimeters (cm) in diameter
排除标准
- •Participation in any investigational drug or device study or early access programme
结局指标
主要结局
Percentage of Participants Treated With Chemotherapy in First Line Therapy
时间窗: Day 1
Participants treated with chemotherapy in first line therapy will be reported.
Percentage of Participants Treated With Other Therapies in First Line Therapy
时间窗: Day 1
Participants treated with other therapies including secondary hormone therapy, steroids, radiation therapy, radionuclide therapy, bisphosphonates and best supportive care in first line therapy will be reported.
Percentage of Participants Treated With Chemotherapy in Second Line Therapy
时间窗: Day 1
Participants who were treated with chemotherapy in second line therapy will be reported.
Percentage of Participants Treated With Other Therapies in Second Line Therapy
时间窗: Day 1
Participants treated with other therapies including secondary hormone therapy, steroids, radiation therapy, radionuclide therapy, bisphosphonates and best supportive care in second line therapy will be reported.
次要结局
- Eastern Cooperative Oncology Group (ECOG) Performance Status(Day 1)
- Number of Participants with Comorbidities(Day 1)
- Blood Prostate Specific Antigen (PSA) levels(Day 1)
- Number of participants With Bone or Visceral Metastasis(Day 1)
- Assessment of Pain Related With Disease(Day 1)
- Percentage of Participants With Skeletal Related Events (SREs)(Day 1)
- Number of Participants who were used to define mCRPC Criteria(Day 1)
- Percentage of Participants Who Received Therapies After Second Line(Day 1)
- Overall Survival(Day 1)
- Number of Participants With Gleason score(Day 1)