NCT07112612

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

Application of Personalized Minimal Residual Disease in Predicting Therapeutic Efficacy in Metastatic Hormone-sensitive Prostate Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2026-01-30
• Primary completion: 2026-12-30
• Completion: 2027-04-30
• First posted: 2025-08-08
• Last updated: 2026-01-12