This research project aims to develop a novel blood testing method integrating cutting-edge quantum sensing and artificial intelligence technologies to achieve precise, non-invasive early diagnosis of prostate cancer. The research will employ quantum sensors to perform ultra-high-sensitivity measurements of circulating free DNA (cfDNA) in blood, thereby training a dedicated AI diagnostic model. The ultimate objective is to establish the diagnostic efficacy of this approach through clinical validation, providing clinicians with a novel diagnostic tool capable of significantly reducing unnecessary prostate biopsy procedures.

Inclusion Criteria:

1. Male, aged 18-80 years;

2. PSA > 4 ng/ml;

3. 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:

1. Patients diagnosed with any malignant tumour within the past five years;
2. Patients who have undergone transurethral resection or enucleation of the prostate;
3. Patients who have previously received treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, or immunotherapy;
4. Patients on long-term anticoagulant or antiplatelet therapy (anticoagulants discontinued for less than one week);
5. Patients who have received any form of tumour treatment prior to enrolment blood sampling, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, or immunotherapy;
6. 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;
7. Organ transplant recipients or individuals with prior non-autologous (allogeneic) bone marrow or stem cell transplantation;
8. Subjects who have undergone blood transfusion within one month prior to blood sampling;
9. Patients currently participating in other clinical trials, or who have participated in other clinical trials within the past year;
10. Patients deemed unsuitable for this clinical trial by the investigator;
11. Patients meeting any of the above criteria shall not be eligible for inclusion as subjects.

Males aged 18-80 years with elevated PSA (>4 ng/ml) and clinical indications for prostate biopsy.