Application of a Novel Biomarker Based on Plasma cfDNA Assay in the Early Diagnosis of Prostate Cancer

Naval Military Medical University (Second Military Medical University)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Diagnostic Test: Blood draw

Study type: Observational

Funder types: Other

Identifiers

NCT06509919

KAL1

Details and patient eligibility

About

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.

Enrollment: 1,100 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 other serious systemic diseases that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial, including serious respiratory, circulatory, neurological, psychiatric, gastrointestinal, endocrine, immune, urinary and other systemic diseases;
7. Organ transplant recipients or prior non-autologous (allogeneic) bone marrow or stem cell transplant population;
8. Subjects who have had a blood transfusion 1 month prior to the blood draw;
9. Patients who are participating in other clinical trials, or who have participated in other clinical trials that have been completed less than 1 year ago;
10. Patients who, in the judgment of the investigator, are not suitable for participation in this clinical trial;
11. Patients who meet any of the above criteria may not be included as subjects.

Trial design

1,100 participants in 1 patient group

Patients with elevated PSA test results (4-10ng/ml)

Treatment:

Diagnostic Test: Blood draw