A Multicentre Observational Study on Treatment Patterns and ctDNA HRR Evaluation in Aggressive High-volume Metastatic Hormone-sensitive Prostate Cancer in Russian Federation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 400
- 试验地点
- 26
- 主要终点
- Proportion of patients received any ADT
研究概览
简要总结
A multicentre observational study on treatment patterns and ctDNA HRR evaluation in aggressive high-volume 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 on HRRm evaluation in ctDNA in patients with high-aggressive high-volume mHSPC with known tumor HRRm status 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 high-aggressive (Gleason 8-10) high-volume mHSPC with available medical history and known tumor HRRm status, which has been determined from a tumour sample obtained from the patient as part of routine practice. It is estimated that approximately 400 patients will be enrolled in about 30 sites. In this case, the ratio of patients with HRR gene mutations (HRRm) to patients with wild-type HRR genes (HRRwt) will be approximately 5:3 (250 HRRm and 150 HRRwt), so that both populations are represented in the study sample, including patients without mutations.
The study will include two visits carried out according to routine clinical practice. At baseline visit (visit 1) demographic and clinical characteristics and treatment approaches from the date of high-aggressive high-volume mPC diagnosis (date of first metastases verification) till enrollment will be collected based on the patient's medical records. In case of absence of data required to be collected by the protocol, additional data may be obtained during patient's interview directly and recorded in the source documents related to the visit. For ctDNA and ctDNA-based HRRm testing (by NGS) routinely collected blood samples will be used. Testing will be performed in central laboratories.
Visit 2 (final visit) will be conducted at the time of disease progression or after 12 (±3) months (whichever occurs first) to collect follow-up data on progression to mCRPC and subsequent treatment, if applicable. If the patient is unable to visit the study site (e.g. in case the patient is being treated and observed at the place of residence) the data collection of visits 2 could be carried out via telephone contact.
All study data will be 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.
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 blood samples ctDNA and ctDNA-based HRRm testing;
- •Metastatic hormone-sensitive prostate cancer (mHSPC) (de novo or progressed from earlier stages);
- •High-aggressive disease (Gleason 8-10);
- •High-volume disease (according to CHAARTED trial criteria: presence of 4 and more (≥4) bone metastases (including at least one (≥1) outside the vertebral column/pelvis) and/or 1 and more (≥1) visceral metastasis);
- •Availability of source medical documentation;
- •Known HRRm status based on tumour sample evaluation performed in routine practice.
排除标准
- •Participation in any interventional trial since the mPC diagnosis.
- •Progression to mCRPC.
结局指标
主要结局
Proportion of patients received any ADT
时间窗: 36 months
Proportion of patients received any Androgen deprivation therapy
Proportion of patients received ADT by each type and by each drug
时间窗: 36 months
Proportion of patients received Androgen deprivation therapy by each type and by each drug
Proportion of patients received first generation antiandrogens
时间窗: 36 months
Proportion of patients received first generation antiandrogens
Proportion of patients received androgen receptor pathway inhibitors (ARPI) at mHSPC
时间窗: 36 months
Proportion of patients received androgen receptor pathway inhibitors (ARPI) at mHSPC overall and by each drug;
Duration of ARPI therapy
时间窗: 36 months
Duration (months) of androgen receptor pathway inhibitors (ARPI) therapy
Proportion of patients received any chemotherapy at mHSPC
时间窗: 36 months
Proportion of patients received any chemotherapy at metastatic hormone-sensitive prostate cancer
Duration of chemotherapy
时间窗: 36 months
Duration (months) of chemotherapy, No. of cycles of chemotherapy;
Proportion of patients received radiation therapy
时间窗: 36 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: 36 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
时间窗: 36 months
Proportion of patients underwent surgery at Metastatic hormone-sensitive prostate cancer stage overall and by each type (if applicable);
Proportion of patients received triplet therapy at mHSPC
时间窗: 36 months
Proportion of patients received triplet therapy (ADT + ARPI + chemotherapy) at Metastatic hormone-sensitive prostate cancer overall and by each ARPI;
Time from mPC diagnosis to progression to mCRPC
时间窗: 36 months
Time from Metastatic prostate cancer diagnosis to progression to Metastatic castration-resistant prostate cancer (mCRPC) (calculated between the date of confirmed metastatic disease diagnosis and the date of progression to mCRPC) in the total sample and in different subgroups (HRRm/HRRwt, ctDNA+/ctDNA-, different therapeutical approaches);
Proportion of patients with each site of disease progression
时间窗: 36 months
Proportion of patients with each site of disease progression (metastases);
Testosterone level at the time of mCRPC
时间窗: 36 months
Testosterone level (nmol/l) at the time of castrate-resistant disease (mCRPC diagnosis);
Proportion of patients with presence of pathogenic mutations in HRR genes in ctDNA
时间窗: 36 months
Proportion of patients with presence of pathogenic mutations in Homologous recombination repair (HRR) genes detected in culating tumor DNA (ctDNA) by Next Generation Sequencing (NGS) overall and by each gene.
次要结局
- Age at the diagnosis of high-aggressive high-volume mPC(36 months)
- Proportion of patients of different races and ethnicities(36 months)
- Proportion of patients with presence of a family oncology history(36 months)
- Proportion of patients with a personal oncology history(36 months)
- Proportion of patients with each category by ECOG assessmen(36 months)
- Proportion of patients with each type of mPC diagnosi(36 months)
- Proportion of patients with each stage by TNM classification(36 months)
- Proportion of patients with each histological type of tumor(36 months)
- Proportion of patients with each category by Gleason scale(36 months)
- Time from initial diagnosis to mPC diagnosis(36 months)
- Proportion of patients with each localization of metastases at the diagnosis of mPC(36 months)
- PSA level at the diagnosis of mPC(36 months)
- Proportion of patients with each HRR mutation among all HRRm patient(36 months)
- Proportion of patients with each source of tumor sample(36 months)
- Proportion of patients with presence of ctDNA(36 months)
- ctDNA HRRm/HRRwt and tumor HRRm/HRRwt coincidence rate(36 months)