Metastatic Hormone - Sensitive Prostate Cancer
Conditions
Interventions
Group 1:None
Group 2:None
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntarily signed informed consent form and able to understand and agree to comply with study requirements; 2.Age >=18; 3.Male; 4.Patients diagnosed with metastatic hormone-sensitive prostate cancer via CSCO guidelines, histopathology, etc; 5.Patients who need to receive darolutamide triple therapy according to the treating physician's judgment; 6.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; 7.Life expectancy of over 1 year; 8.Good compliance with regular serum PSA testing during treatment;
Exclusion criteria
Exclusion criteria: 1.Presence of other malignancies within the past 2 years or currently; 2.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; 3.Allergy to any study drug or excipient; 4.Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake/absorption; 5.Underlying medical condition/alcohol or drug abuse/dependence that may interfere with drug administration, result in adverse events, or complicate outcome interpretation; 6.Participation in another therapeutic clinical study; 7.Deemed unsuitable for the study by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life score;Safety;Overall Survival;Progression - Free Survival;Time to CRPC; | — |
Countries
China
Contacts
Public ContactQiang Dang
Southern Medical University Southern Hospital
Outcome results
None listed