Application of Quantum Detection-Driven Artificial Intelligence Algorithms for Single-Molecule cfDNA Characterization in the Early Diagnosis of Prostate Cancer

Inclusion criteria

• Male, aged 18-80 years;
• PSA > 4 ng/ml;
• Patients meeting criteria for prostate biopsy:

• fPSA/PSA < 0.16 or PSA D > 0.15 or PSA V > 0.75; ② Positive digital rectal examination (DRE); ③ Imaging studies (ultrasound/MRI) showing suspicious lesions.

Exclusion criteria

• Patients diagnosed with any malignant tumour within the past five years;
• Patients who have undergone transurethral resection or enucleation of the prostate;
• Patients who have previously received treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, or immunotherapy;
• Patients on long-term anticoagulant or antiplatelet therapy (anticoagulants discontinued for less than one week);
• Patients who have received any form of tumour treatment prior to enrolment blood sampling, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, or immunotherapy;
• Concurrent severe systemic diseases deemed by the investigator likely to interfere with trial treatment, evaluation, or compliance, including serious respiratory, circulatory, neurological, psychiatric, gastrointestinal, endocrine, immunological, or urological disorders;
• Organ transplant recipients or individuals with prior non-autologous (allogeneic) bone marrow or stem cell transplantation;
• Subjects who have undergone blood transfusion within one month prior to blood sampling;
• Patients currently participating in other clinical trials, or who have participated in other clinical trials within the past year;
• Patients deemed unsuitable for this clinical trial by the investigator;
• Patients meeting any of the above criteria shall not be eligible for inclusion as subjects.