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NCT07154914Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 4 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
396 (estimated)
First submitted
27 Aug 2025
Start date
1 Sept 2025
Primary completion date
1 Sept 2026
Lead sponsor
Anhui Medical University
NCT number
NCT07154914

What you commit to

  • Study type: Observational
  • Planned participants: 396
  • From 1 Sept 2025 to the primary completion date, 1 Sept 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior systemic therapy for prostate cancer (neoadjuvant, adjuvant, or systemic).
  • Concurrent participation in another clinical trial.

Other illness

  • Histological diagnosis of neuroendocrine or small-cell prostate cancer.
  • 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).
  • Any condition deemed unsuitable for study participation by the investigator.

Other

  • No evidence of distant metastases on imaging.
  • Inability to provide clinical information or anticipated loss to follow-up.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 85 years · Sex: Male

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.