About this trial
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.
Eligibility criteria
Qualifiers
Male, aged 18-80 years;
PSA > 4 ng/ml;
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.
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Quantum Detection
- Quantum Detection
- Quantum Detection
Treatment groups
Sponsors and collaborators
Shanghai Changzheng Hospital
Lead sponsor
West China Hospital
Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator
The First Affiliated Hospital of Guangzhou Medical University
Collaborator
First Affiliated Hospital of Ningbo University
Collaborator
Jiangsu Provincial People's Hospital
Collaborator
The First Affiliated Hospital of Soochow University
Collaborator