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

NCT07112612 | Not Yet Recruiting

• 1 other identifier: PJ 2024-11-47
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

MRD; Prostate Cancer; mHSPC

Keywords

minimal residual disease; MRD; PCa

Outcome Measures

Primary Outcomes (1)

• minimal residual disease(MRD) positive rate

  The probability of patients in the study cohort testing positive using the minimal residual disease (MRD) test kit.

  baseline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with metastatic hormone-sensitive prostate cancer

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.

Sponsors & Collaborators

• Anhui Medical University: lead

Biospecimen

Retention: SAMPLES WITH DNA

prostate needle biopsy tissue and bone metastasis needle biopsy tissue.

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 8, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share