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A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India (PACE mHSPC)

2026年9月9日 更新者：Bayer

An Active Post Marketing Surveillance (PMS) Observational Study of Darolutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

This study will follow patients with metastatic hormone-sensitive prostate cancer in India who receive darolutamide plus androgen deprivation therapy as part of routine medical care. The study aims to describe the real-world safety profile of darolutamide plus androgen deprivation therapy over up to 1 year of follow-up, including adverse events, serious adverse events, adverse events categorized as special topics, treatment changes, and changes in laboratory values, vital signs, and Eastern Cooperative Oncology Group performance status.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

50

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 印度
      • Many Locations、印度
        • Many locations

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Male patients with a diagnosis of metastatic hormone sensitive prostate cancer (mHSPC) will be enrolled after the decision for treatment with darolutamide has been made by the physician.

描述

Inclusion Criteria:

  • Men over the age of 18 years
  • Histologically or cytologically confirmed adenocarcinoma of prostate
  • Metastatic disease (metastatic hormone sensitive prostate cancer) documented by either by a positive bone scan, or for soft tissue either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by investigators
  • The decision to initiate treatment with darolutamide plus androgen deprivation therapy (ADT) was made as per the investigator's routine treatment practice
  • Written informed consent

Exclusion Criteria:

  • Participation in an interventional clinical trial program with interventions outside of routine clinical practice
  • Any condition that, in investigator's opinion, precludes reliable safety follow-up.
  • Concomitant use or planned to start the use of docetaxel/any other androgen receptor inhibitors/radiation therapy/chemotherapy or immunotherapy
  • Known hypersensitivity to the study drug or any of its ingredients
  • Metastatic castration resistant prostate cancer (mCRPC) disease

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Single-arm post marketing surveillance cohort
Patients with metastatic hormone-sensitive prostate cancer in India who are treated with darolutamide in combination with androgen deprivation therapy as part of routine clinical practice
药品：Darolutamide plus androgen deprivation therapy
Darolutamide 300 mg film-coated tablets in combination with androgen deprivation therapy (ADT). The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.
其他名称：
  • 湾 1841788
  • 努贝卡

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence and severity of adverse events and serious adverse events
大体时间：From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
Occurrence of adverse events, including AE/SAE terms, dates, severity as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, causality, outcome, actions taken, and seriousness criteria
From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
Incidence of discontinuations and dose modifications of study drug due to adverse events
大体时间：From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
Adverse event-related drug discontinuations/modifications, including adverse events leading to dose modification/discontinuation, dates, and reason
From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months

次要结果测量

结果测量
措施说明
大体时间
Changes in hematology laboratory parameters: hemoglobin
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: hematocrit
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: erythrocyte count
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: leukocyte count
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: lymphocytes
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: monocytes
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: eosinophils
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: neutrophils
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: basophils
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: mean corpuscular hemoglobin
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: mean corpuscular volume
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: mean corpuscular hemoglobin concentration
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: thrombocytes
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: albumin
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: alanine aminotransferase
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: aspartate aminotransferase
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: alkaline phosphatase
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: gamma-glutamyl transferase
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: bilirubin total and direct
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: calcium
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: blood urea nitrogen
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: creatinine
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: serum glucose
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: total protein
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: lactate dehydrogenase
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: sodium
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: potassium
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: chloride
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: bicarbonate
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: testosterone
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: total prostate-specific antigen (PSA)
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: prothrombin time
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: international normalized ratio (INR)
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: specific gravity
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: pH, by dipstick
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: glucose, by dipstick
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: protein, by dipstick
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: blood, by dipstick
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: ketones, by dipstick
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: microscopic examination
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Microscopic examination, if blood or protein urinalysis by dipstick is abnormal
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Results of other safety laboratory tests
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Results of other safety laboratory tests performed as deemed necessary by the investigator
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in Eastern Cooperative Oncology Group performance status and vitals
大体时间：Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Eastern Cooperative Oncology Group performance status on a scale from 0 to 5
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Incidence and severity of adverse events categorized as special topics
大体时间：From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months

Occurrence of adverse events categorized as special topics, including category, severity as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, causality, actions taken, hospitalization, and discontinuation. Special topics are defined as:

  • hypertension
  • vasodilatation and flushing
  • diabetes mellitus and hyperglycemia
  • cardiac arrhythmias
  • fatigue
  • rash
  • bone fracture, excluding pathological fractures
  • coronary artery disorders
  • decreased weight
  • mental-impairment disorder
  • falls, including accident
  • heart failure
  • depressed-mood disorder
  • seizures
  • gynecomastia
  • cerebral ischemia.
From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
Drug administration status
大体时间：From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months
Drug exposure and modifications, including start/stop dates, dose, interruptions, reductions, discontinuation reasons, and cumulative dose
From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bayer

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月5日

初级完成 (估计的)

2028年10月31日

研究完成 (估计的)

2028年10月31日

研究注册日期

首次提交

2026年8月18日

首先提交符合 QC 标准的

2026年9月1日

首次发布 (实际的)

2026年9月8日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月9日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 23276

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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