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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose of docetaxel | Drug | According to the relative dose intensity of docetaxel (RDI; Defined as the ratio of the dose received to the full planned dose of 75mg/m2 per 6 cycles specified in the protocol) were divided into cohort 1 (patients receiving docetaxel dose intensity ≤80%) and cohort 2 (patients receiving docetaxel dose intensity ≤80%). A total of 50 patients who received docetaxel dose intensity > 80% were planned to be enrolled, including 25 patients in the docetaxel dose intensity ≤80% group and 25 patients in the docetaxel dose intensity > 80% group |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month prostate-specific antigen (PSA) undetectable rate | The proportion of patients with PSA <0.2 ng/mL after 6 months of treatment | From the beginning of the patient's treatment to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological progression-free survival | Time from treatment initiation to radiological progression | From the beginning of the patient's treatment to 6 months |
| PSA kinetics curve | The PSA decline curve from the start of ADT, darolutamide, and docetaxel treatment to the completion of docetaxel. |
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Inclusion Criteria:
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;
Exclusion Criteria:
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.
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The study population consists of patients diagnosed with metastatic hormone-sensitive prostate cancer who have chosen to receive darolutamide triplet therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wu Y Wang | Contact | China+15066541238 | 1470329253@qq.com |
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| Every 3 weeks during the triplet therapy, and every month after treatment. |