Status:
NOT_YET_RECRUITING
A Novel Insight Into CRPC Progression and Immune: Evidence From Single-cell Spatial Transcriptome Multi-omics
Lead Sponsor:
Anhui Medical University
Conditions:
Metastatic Hormone-Sensitive Prostate Cance
Eligibility:
MALE
18-85 years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT07154914
Start Date
September 1 2025
End Date
September 1 2026
Last Update
September 4 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.