Minimal Residual Disease Used in Predicting Therapeutic Efficacy in Metastatic Hormone-sensitive Prostate Cancer

Launched by ANHUI MEDICAL UNIVERSITY · Aug 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a type of prostate cancer called metastatic hormone-sensitive prostate cancer (mHSPC), which means the cancer has spread to other parts of the body but still responds to hormone treatment. The study aims to see how well different treatments work by looking for tiny amounts of cancer cells left in the body after treatment, called minimal residual disease (MRD). Researchers will also look at gene changes in the cancer to understand which treatments might work best for different patients. This information could help doctors give more personalized and effective care in the future.

Men between 18 and 85 years old who have recently been diagnosed with prostate cancer that has spread to other areas and have not yet had hormone or other cancer treatments may be eligible. Participants will need to have good overall health and organ function and agree to regular check-ups and tests during the study. This is an observational study, so patients will receive standard treatments while doctors carefully watch how their cancer responds, especially by checking for MRD. This study is not yet recruiting participants but aims to improve how we predict and monitor treatment success in men with this type of prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18 years and younger than 85 years;
• • 2. Patients diagnosed with prostate acinar adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma by pathological histology;
• • 3. Patients with clear distant metastases found by imaging (in accordance with RECIST criteria);
• • 4. Patients with locally advanced (N1) and metastatic (M1) prostate cancer at diagnosis.
• • 5. Patients who have not received endocrine therapy or other systemic anti-tumor treatments in the past;
• • 6. ECOG score of 0-2 points, with an expected survival period of more than 6 months;
• • 7. Patients with normal organ function;
• 8. Routine blood test (no blood transfusion or blood products within 14 days):
• • Hemoglobin (HGB) ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L (1500 /mm3); Platelet count (PLT) ≥ 75×109/L; White blood cell count (WBC) ≥ 3×109/L;
• 9. Biochemical examination:
• • Total bilirubin (TBIL) ≤ upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN; Creatinine clearance (CCr) ≥ 30ml/min; (Cockcroft-Gault formula);
• • 10. Coagulation function: prothrombin international normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) \< 4 seconds;
• • 11. Patients agree to sign informed consent and are able to attend scheduled study visits, provide clinical information, and cooperate with other study procedures.
• Exclusion Criteria:
• • (1) Patients diagnosed with neuroendocrine/small cell prostate cancer by pathological histology; (2) No clear distant metastasis was found by imaging (in accordance with RECIST criteria); (3) Patients with a history of previous treatment: including neoadjuvant and adjuvant therapy; (4) The samples submitted for examination failed to meet the quality control requirements.
• • (5) Patients with combined endocrine, metabolic system diseases or other serious digestive system diseases; (6) Patients with combined chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency and other diseases; (7) Patients with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (8) Patients with a history of other malignant tumors; (9) Patients enrolled in other clinical trials; (10) Patients unable to obtain the clinical information required for the study (e.g., patients lost to follow-up); (11) Other situations that the researchers consider unsuitable for enrollment.