Application of a Novel Model Based on Plasma cfDNA Assay and MRl Imaging in the Detection of Prostate Cancer

The goal of this diagnostic test is to obtain multiple cell-free DNA （cfDNA） fragment profiles of subjects by whole genome sequencing based on plasma cfDNA, build a prostate cancer prediction model by machine learning, and to validate the efficacy of this model in patients who need to undergo needle prostate biopsy base on their prostate-specific antigen（PSA） or clinical or imaging evidence. Therefore, this study aims to explore the efficacy of this prostate cancer prediction model in distinguishing between patients with PSA "gray zone" (4-10 ng/ml) in the diagnosis of prostate cancer and patients with clinically significant prostate cancer.

NCT Number	NCT06509919
Lead Sponsor	Shanghai Changzheng Hospital Collaborators: Ningbo No. 1 Hospital, The First Affiliated Hospital of Guangzhou Medical University, Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Soochow University, West China Hospital, Zhongda Hospital, Northern Jiangsu People's Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Changhai Hospital
Conditions	Prostate Cancer
Enrollment	1,600 participants
Start Date	2024-07-09
Primary Completion	2026-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-23