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

NCT ID: NCT07154914

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 396 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-09-01

Brief Summary

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.

Conditions

Metastatic Hormone-Sensitive Prostate Cance

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Abiraterone + ADT

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Zhang Meng

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

AYFY2025-08-27

Identifier Type: -

Identifier Source: org_study_id