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

NCT ID: NCT07112612

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-30
• Study Completion Date: 2027-04-30

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.

Detailed Description

This is a prospective, single-center, observational study designed to observe the therapeutic response of metastatic hormone-sensitive prostate cancer(mHSPC) patients with different gene mutation characteristics to treatment regimens. The study will recruit 50 mHSPC patients from the First Affiliated Hospital of Anhui Medical University and design a personalized minimal residual disease (MRD) kit based on the data of the biopsy before treatment. The blood routine, biochemical indicators, sex hormone levels, prostate multi-parameter magnetic resonance imaging (Mp-MRI), quantitative whole-body bone examination, and PSMA-PET-CT examination of the study cohort patients will be recorded. During the treatment, MRD will be tested every three months, and the MRD level, blood routine, biochemical markers, sex hormone levels, and PSA levels; patients in the study cohort will undergo prostate multiparametric magnetic resonance imaging (Mp-MRI) and quantitative whole-body skeletal examination every three months. If PSA progression occurs during follow-up, the PSA recheck frequency will be customized. This prospective, observational study will explore the response efficiency of mHSPC patients with different gene mutation types to treatment regimens through MRD detection, analyze the relevant factors affecting the efficacy, and provide a basis for the precise clinical diagnosis and treatment of mHSPC patients.

Conditions

MRD; Prostate Cancer; mHSPC

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Sheng Tai

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PJ 2024-11-47

Identifier Type: -

Identifier Source: org_study_id