Application of a Novel Biomarker Based on Plasma cfDNA Assay in the Early Diagnosis of Prostate Cancer
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Male, 18-80 years old; 2. PSA: 4-10ng/ml; 3. Patients scheduled for prostate biopsy： * fPSA（free PSA）/PSA \< 0.16 or PSAD（PSA density） \> 0.15 (ng/mL/cm³) or PSAV（PSA velocity） \> 0.75 (ng/mL/year) ② positive DRE （digital rectal examination） ③suspicious positive lesions on ultrasound/MRI). Exclusion Criteria: 1. Patients with a prior diagnosis of any malignancy within 5 years; 2. Patients who have undergone prior transurethral resection or enucleation of the prostate; 3. Patients who have received prior treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, and immunotherapy; 4. Patients with long-term use of anticoagulant and antiplatelet aggregation drugs (anticoagulant discontinued for less than 1 week); 5. Received any form of oncological treatment, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, and immunotherapy prior to enrollment for blood sampling; 6. concurrently suffering from