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
This trial does not accept healthy volunteersQualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Abiraterone + ADT
DrugPatients 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Time to progression to castration-resistant prostate cancer (CRPC)
Time frame
Up to 36 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: