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A real-world study of darolutamide combined with ADT in the treatment of patients with metastatic hormone-sensitive prostate cancer

A real-world study of darolutamide combined with ADT in the treatment of patients with metastatic hormone-sensitive prostate cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111988
Enrollment
Unknown
Registered
2025-11-08
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Interventions

Observation group of Metastatic hormone-sensitive prostate cancer:None

Sponsors

Affiliated Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Men over the age of 18 2. Newly diagnosed mHSPC patients 3. Good physical condition, with an ECOG score of 0-1 4. The patient voluntarily participated in the study and signed the informed consent form

Exclusion criteria

Exclusion criteria: 1. Previously received second-generation anti-androgen therapy (such as abiraterone, apatamide, enzalutamide, rivelutamide), etc 2. Combined with other malignant tumors 3. Previous history of radiotherapy and chemotherapy 4. There are serious cardiovascular diseases (such as myocardial infarction, heart failure or unstable angina pectoris) 5. Patients who are allergic to any of the ingredients used in darotamine or ADT treatment 6. Patients who were considered unsuitable for the study by other researchers

Design outcomes

Primary

MeasureTime frame
The duration of PSA < 0.2ng/ml;

Secondary

MeasureTime frame
Overall survival;Safety;Proportion of drug withdrawal;Advances in Imaging;Progress of PSA;

Countries

China

Contacts

Public ContactGe Huixin

Affiliated Hospital of Guizhou Medical University

34865852@qq.com+86 851 8677 3195

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026