A Novel Insight Into CRPC Progression and Immune: Evidence From Single-cell Spatial Transcriptome Multi-omics
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-85
SponsorAnhui Medical University
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
Histological diagnosis of neuroendocrine or small-cell prostate cancer.
No evidence of distant metastases on imaging.
Prior systemic therapy for prostate cancer (neoadjuvant, adjuvant, or systemic).
Severe endocrine, metabolic, gastrointestinal, hepatic, or renal disease (including chronic hepatitis, cirrhosis, chronic nephritis, or renal failure).
Trial design
Treatments tested in this trial
- Abiraterone + ADT
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov