A Novel Insight Into CRPC Progression and Immune: Evidence From Single-cell Spatial Transcriptome Multi-omics

Anhui Medical University

Status: Not yet enrolling

Conditions: Metastatic Hormone-Sensitive Prostate Cance

Treatments: Drug: Abiraterone + ADT

Study type: Observational

Funder types: Other

Identifiers

NCT07154914

AYFY2025-08-27

Details and patient eligibility

About

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.

Enrollment: 396 estimated patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male patients, age >18 and <85 years.

2. Histologically confirmed prostate adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma.

3. Evidence of distant metastases by imaging (according to RECIST criteria).

4. No prior systemic therapy for prostate cancer (no ADT or other systemic treatments).

5. ECOG performance status 0-2 and estimated life expectancy >6 months.

6. 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)

           • INR ≤ 1.5 or PT < 4 sec above ULN

7. Ability to provide written informed consent.

Exclusion criteria

1. Histological diagnosis of neuroendocrine or small-cell prostate cancer.
2. No evidence of distant metastases on imaging.
3. Prior systemic therapy for prostate cancer (neoadjuvant, adjuvant, or systemic).
4. Severe endocrine, metabolic, gastrointestinal, hepatic, or renal disease (including chronic hepatitis, cirrhosis, chronic nephritis, or renal failure).
5. History of immunodeficiency, including HIV positivity, congenital immunodeficiency, or organ transplantation.
6. History of other malignancies (except non-melanoma skin cancer).
7. Concurrent participation in another clinical trial.
8. Inability to provide clinical information or anticipated loss to follow-up.
9. Any condition deemed unsuitable for study participation by the investigator.