A Multicentre Observational Study on Treatment Approaches and Biomarkers in de Novo Metastatic Hormone Sensitive Prostate Cancer in Russian Federation
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- AstraZeneca
- 入组人数
- 400
- 试验地点
- 16
- 主要终点
- Duration of chemotherapy
研究概览
简要总结
A multicentre observational study on treatment approaches and biomarkers in de novo metastatic hormone sensitive prostate cancer in Russian Federation
详细描述
This is a multicentre observational study on treatment approaches, demographic and clinical characteristics and prevalence of biomarkers (PTEN-loss, HER2-positive status; HRR mutations, HRD-positive status) in patients with de novo high-aggressive mHSPC in Russian Federation. The study will sequentially include only those patients who have signed the informed consent form (ICF). No procedures will be applied to patients in addition to the routine clinical practice.
Study population will consist of patients with de novo high-aggressive (Gleason 8-10) histologically confirmed mPC diagnosed within 2 years prior to inclusion with available medical history, biopsy formalin-fixed paraffin-embedded (FFPE) tumour tissue sample. It is estimated that approximately 400 patients will be enrolled in about 30 sites.
Demographic and clinical characteristics, treatment approaches and outcomes will be collected during a single visit carried out according to routine clinical practice. Data from the date of de novo high-aggressive mPC diagnosis (date of histological verification) till enrollment will be collected by study physician based on the patient's medical records and interview during the visit and entered into electronic case report form (eCRF). The study physician will be responsible for ensuring that all required data is collected and entered into the eCRF. No follow-up is planned for patients in this study.
For PTEN-loss and HER2-hyperexpression testing (by IHC) and HRRm (mutations in HRR pathway genes), HRD testing (by NGS [next generation sequencing]) available FFPE tumour tissue sample collected as part of routine clinical practice will be used. Testing will be performed in central laboratories.
Overall expected duration of the study enrollment and data collection (from the first patient inclusion to the final database lock) is about 27 months, or until 400 eligible patients are included to the study and data on these patients are collected (including results of FFPE sample testing), whichever occurs first.
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
- •Male patients aged ≥ 18 years old;
- •Signed ICF, including consent for FFPE tumor tissue sample testing;
- •De novo histologically confirmed high-aggressive (Gleason 8-10) mPC;
- •Diagnosis of mPC (metastatic prostate cancer) within 2 years prior to inclusion;
- •Availability of source medical documentation;
- •Presence of biopsy FFPE tumor tissue sample, obtained as part of standard clinical practice, which will be used for biomarker testing;
- •Unknown HRRm status.
排除标准
- •1. Participation in any interventional trial since the mPC diagnosis.
结局指标
主要结局
Duration of chemotherapy
时间窗: 24 months
Duration of chemotherapy in months (to be calculated if chemotherapy completed before or at the enrollment);
Proportion of patients received any chemotherapy at mHSPC
时间窗: 24 months
Proportion of patients received any chemotherapy at Metastatic hormone-sensitive prostate cancer (mHSPC)
Proportion of patients received any ADT
时间窗: 24 months
Proportion of patients received any Androgen deprivation therapy (ADT)
Proportion of patients received ADT by each type and by each drug
时间窗: 24 months
Proportion of patients received Androgen deprivation therapy (ADT) by each type and by each drug;
Proportion of patients received first generation antiandrogens
时间窗: 24 months
Proportion of patients received first generation antiandrogens;
Proportion of patients received ARPI at mHSPC
时间窗: 24 months
Proportion of patients received androgen receptor pathway inhibitors (ARPI) at Metastatic hormone-sensitive prostate cancer (mHSPC) overall and by each drug;
Proportion of patients received radiation therapy
时间窗: 24 months
Proportion of patients received radiation therapy (RT) overall and by each type (if applicable);
Proportion of patients with each radiation area
时间窗: 24 months
Proportion of patients with each radiation area (if applicable) (to be calculated in patients who received any RT);
Proportion of patients underwent surgery at mHSPC stage
时间窗: 24 months
Proportion of patients underwent surgery at Metastatic hormone-sensitive prostate cancer (mHSPC) stage overall and by each type (if applicable);
Proportion of patients received triplet therapy
时间窗: 24 months
Proportion of patients received triplet therapy (ADT + ARPI + chemotherapy) at mHSPC overall and by each ARPI;
Proportion of patients with PTEN loss by IHC
时间窗: 24 months
Proportion of patients with PTEN (Phosphatase and TENsin homolog) loss by Immunohistochemistry (IHC)
Number of Chemotherapy Cycles
时间窗: 24 months
Number of chemotherapy cycles is defined as the total number of chemotherapy cycles completed prior to or at the time of study enrollment.
次要结局
- Age at the diagnosis of de novo high-aggressive histologically confirmed mPC(24 months)
- Proportion of patients of different races and ethnicities(24 months)
- Proportion of patients with presence of a family oncology history(24 months)
- Proportion of patients with a personal oncology history(24 months)
- Proportion of patients with each category by ECOG assessment(24 months)
- Proportion of patients with each stage by TNM classification(24 months)
- Proportion of patients with each histological type of tumour(24 months)
- Proportion of patients with each category by Gleason scale(24 months)
- Proportion of patients with high and low volume of disease(24 months)
- Proportion of patients with each localization of metastases(24 months)
- Proportion of patients with each source of tumour sample(24 months)
- Proportion of patients with each result of HER2 expression by IHC(24 months)
- Proportion of patients with presence of pathogenic mutations in HRR genes(24 months)
- Proportion of patients with positive HRD status(24 months)