Application of Quantum Detection-Driven Artificial Intelligence Algorithms for Single-Molecule cfDNA Characterization in the Early Diagnosis of Prostate Cancer
Trial ID: NCT07238959
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-12
Completion date: 2027-12
Sponsor: Shanghai Changzheng Hospital
Collaborators: West China Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; The First Affiliated Hospital of Guangzhou Medical University; First Affiliated Hospital of Ningbo University; Jiangsu Provincial People's Hospital; The First Affiliated Hospital of Soochow University
Conditions: Benign Prostate Hypertrophy(BPH); Prostate Cancer (Diagnosis); Prostate Neoplasm
Interventions: Quantum Detection; Quantum Detection; Quantum Detection
Locations: Cancer Hospital, Chinese Academy of Medical Sciences; The First Aﬃliated Hospital of Guangzhou Medical University; Jiangsu Provincial People's Hospital; The First Affiliated Hospital of Soochow University; Shanghai Changzheng Hospital; West China Hospital, Sichuan University; Ningbo No. 1 Hospital
Countries: China; China; China; China; China; China; China
Enrollment: 1100
Age range: 18 Years - 80 Years
Sex: MALE

Summary:
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:
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.

Outcomes:
Area under the receiver operating characteristic curve (AUC-ROC) for the predictive model in the general population for prostate cancer.; Sensitivity of the predictive model in detecting prostate cancer within the general population.; Specificity of the predictive model in detecting prostate cancer within the general population.