Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will follow patients with metastatic hormone-sensitive prostate cancer (mHSPC) who receive androgen deprivation therapy (ADT) combined with different treatments. Prostate cancer is a common cancer in men, and many patients in China are diagnosed at an advanced stage. While ADT alone has been the standard treatment, most patients eventually progress to castration-resistant disease.
New medicines such as abiraterone, enzalutamide, apalutamide, darolutamide, and chemotherapy like docetaxel have shown survival benefits when added to ADT. This study aims to observe how different ADT-based combinations work in real-world practice and whether genetic differences affect outcomes.
About 396 patients will be enrolled and followed until disease progression or death. The results will help identify which treatments are most effective and guide more personalized care for men with advanced prostate cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone + ADT | Drug | Patients receiving androgen deprivation therapy (ADT) combined with abiraterone. Abiraterone is a CYP17A1 inhibitor used in combination with prednisone and ADT for metastatic hormone-sensitive prostate cancer (mHSPC). This combination is given in real-world practice according to clinical guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression to castration-resistant prostate cancer (CRPC) | Up to 36 months |
Not provided
Not provided
Inclusion Criteria:
Male patients, age >18 and <85 years.
Histologically confirmed prostate adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma.
Evidence of distant metastases by imaging (according to RECIST criteria).
No prior systemic therapy for prostate cancer (no ADT or other systemic treatments).
ECOG performance status 0-2 and estimated life expectancy >6 months.
Adequate organ function as indicated by:
Hemoglobin ≥ 90 g/L
ANC ≥ 1.5 × 10^9/L
Platelet count ≥ 75 × 10^9/L
WBC ≥ 3 × 10^9/L ⑤ Total bilirubin ≤ ULN ⑥ ALT/AST ≤ 2.5 × ULN ⑦ Creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula)
Ability to provide written informed consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
Male patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC), recruited from multiple centers in China. Eligible patients are treatment-naïve and will receive androgen deprivation therapy (ADT) combined with different regimens according to real-world clinical practice.
Not provided
| ID | Term |
|---|---|
| C089740 | abiraterone |
| D000726 | Androgen Antagonists |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
Not provided
Not provided
Not provided
Not provided
Not provided
| D020164 | Chemical Actions and Uses |