Prospective Real-world Data Evaluation of Darolutamide (DARO) in Combination With Androgen-deprivation Therapy (ADT) and Docetaxel (DOC) in Patients With Metastatic Hormone-sensitive Prostate Cancer

Nanfang Hospital, Southern Medical University0 个研究点目标入组 50 人开始时间: 2025年6月1日最近更新: 2025年6月22日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Nanfang Hospital, Southern Medical University
入组人数: 50
主要终点: 6-month prostate-specific antigen (PSA) undetectable rate

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to investigate the clinical efficacy and safety of darolutamide combined with androgen deprivation therapy (ADT) and different dose-intensity docetaxel chemotherapy in the treatment of patients with metastatic hormone-sensitive prostate cancer.

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

•Voluntarily signed informed consent form and able to understand and agree to comply with study requirements; Age ≥18； Male； Patients diagnosed with metastatic hormone-sensitive prostate cancer via CSCO guidelines, histopathology, etc.； Patients determined by treating physician to require darolutamide triplet therapy ECOG performance status score of 0-1 as evaluated by the Eastern Cooperative Oncology Group (ECOG) criteria； Life expectancy of over 1 year； Good compliance with regular serum PSA testing during treatment；

排除标准

•Presence of other malignancies within the past 2 years or currently; Severe cardiovascular/cerebrovascular disease within 6 months prior to study treatment initiation, including: severe/unstable angina, myocardial infarction, congestive heart failure [NYHA Class III or worse], stroke, or arrhythmia requiring medication; Allergy to any study drug or excipient; Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake/absorption; Underlying medical condition/alcohol or drug abuse/dependence that may interfere with drug administration, result in adverse events, or complicate outcome interpretation; Participation in another therapeutic clinical study; Deemed unsuitable for the study by the investigator.

结局指标

主要结局

6-month prostate-specific antigen (PSA) undetectable rate

时间窗: From the beginning of the patient's treatment to 6 months

The proportion of patients with PSA \<0.2 ng/mL after 6 months of treatment

次要结局

Radiological progression-free survival(From the beginning of the patient's treatment to 6 months)
PSA kinetics curve(Every 3 weeks during the triplet therapy, and every month after treatment.)

研究者

发起方

Nanfang Hospital, Southern Medical University

申办方类型

Other

责任方

Sponsor

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