Metastatic Hormone-Sensitive Prostate Cancer
Conditions
Interventions
Initiate chemotherapy immediately.:Initiate chemotherapy immediately upon starting ADT + novel endocrine therapy.
Start chemotherapy within 4 to 6 weeks after diagnosis.:Start chemotherapy 4 to 6 weeks after initiating ADT + novel endocrine therapy following diagnosis.
Sponsors
The Second Hospital of Tianjin Medical University
Eligibility
Sex/Gender
Male
Age
40 Years to 90 Years
Inclusion criteria
Inclusion criteria: Age >= 18 years. Patients have undergone prostate biopsy with a pathological diagnosis of adenocarcinoma (including acinar adenocarcinoma, ductal adenocarcinoma, and intraductal carcinoma) and without evidence of neuroendocrine differentiation or small cell features. Newly diagnosed prostate cancer (within 3 months prior to enrollment). Undergone PSMA-PET/CT or bone scan within 6 weeks prior to treatment, confirming high tumor burden: =4 bone metastases (with at least one located outside the pelvis or spine) or the presence of visceral metastases. Complete medical records and follow-up data available for the patient. Voluntarily participate in this clinical trial, understand the study procedures, and have provided signed informed consent.
Exclusion criteria
Exclusion criteria: Life expectancy < 1 year. Severe hepatic impairment (Child-Pugh class C). Severe renal impairment requiring long-term dialysis. Severe bone marrow suppression or severe neutropenia. Planned receipt of any other anti-tumor therapy during the trial period. Patients unable to complete the study follow-up plan. Previous other malignancy not clinically cured or ongoing pelvic radiotherapy, chemotherapy, immunotherapy, etc. History of endocrine diseases (e.g., hypothalamus, pituitary disorders) affecting the patient's androgen levels.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to PSA Progression;Time to Radiographic Progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Castration-Resistant Prostate Cancer (CRPC) Progression;PSA Complete Response (CR) Rate at 6 Months;PSA Complete Response (CR) Rate at 12 Months;Skeletal-Related Events (SRE); | — |
Countries
China
Contacts
Public ContactWen Simeng
The Second Hospital of Tianjin Medical University
Outcome results
None listed