Menu
Not yet recruiting NCT07154914

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

— Observational Metastatic Hormone-Sensitive Prostate Cance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Abiraterone + ADT.
Who it may be relevant to
Registry conditions: Metastatic Hormone-Sensitive Prostate Cance. Basic parameters: 18 years — 85 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Mapping Prostate Cancer Evolution and Therapy Resistance With Single-Cell Technologies

Overview

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.

Interventions

  • Drug 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.

Primary outcome measures

  • Time to progression to castration-resistant prostate cancer (CRPC) [Time frame: Up to 36 months]

Eligibility criteria

Inclusion criteria

  • 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).
  • ECOG performance status 0-2 and estimated life expectancy >6 months.
  • 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
  • Ability to provide written informed consent.

Exclusion criteria

  • 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).
  • History of immunodeficiency, including HIV positivity, congenital immunodeficiency, or organ transplantation.
  • History of other malignancies (except non-melanoma skin cancer).
  • Concurrent participation in another clinical trial.
  • Inability to provide clinical information or anticipated loss to follow-up.
  • Any condition deemed unsuitable for study participation by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07154914 · AYFY2025-08-27

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗