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

Starting soon

Conditions studied: MRD, Prostate Cancer, mHSPC

In brief

This study is a prospective, single-center, observational study of patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC). Minimal residual disease (MRD) detection is used to investigate the actual efficacy responses of mHSPC patients with different gene mutation characteristics to treatment regimens. Factors influencing efficacy are further analyzed to provide a basis for the precise clinical diagnosis and treatment of mHSPC patients.

Key facts

Study ID

NCT07112612

Run by

Anhui Medical University

People needed

50

Starts

2026-01-30

Expected to finish

2027-04-30

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 years and younger than 85 years;
• Patients diagnosed with prostate acinar adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma by pathological histology;
• Patients with clear distant metastases found by imaging (in accordance with RECIST criteria);
• Patients with locally advanced (N1) and metastatic (M1) prostate cancer at diagnosis.
• Patients who have not received endocrine therapy or other systemic anti-tumor treatments in the past;
• ECOG score of 0-2 points, with an expected survival period of more than 6 months;
• Patients with normal organ function;
• 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;
• 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);
• Coagulation function: prothrombin international normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) < 4 seconds;
• Patients agree to sign informed consent and are able to attend scheduled study visits, provide clinical information, and cooperate with other study procedures.

You may not qualify if…

• (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.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.