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

Launched by SHANGHAI CHANGZHENG HOSPITAL · Jul 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new test that analyzes DNA from the blood to help doctors diagnose prostate cancer earlier. The researchers are using a method to look at tiny pieces of DNA that are released into the blood from dying cells. By examining these pieces, they hope to create a model that can predict whether a patient is likely to have prostate cancer, especially for those who have a PSA level that is considered uncertain (between 4 and 10 ng/ml). This model will be tested on men who are scheduled for a prostate biopsy to see if it can effectively distinguish between those who have significant prostate cancer and those who do not.

To participate in this trial, you need to be a man aged 18 to 80 with a PSA level between 4 and 10 ng/ml, and you must be scheduled for a prostate biopsy for specific medical reasons. If you join the study, you will provide a blood sample for the DNA test, and the results will help improve early detection methods for prostate cancer. It’s important to note that there are certain health conditions and treatments that may prevent you from participating, but the study aims to include as many eligible individuals as possible to enhance prostate cancer diagnosis.

Gender

MALE

Eligibility criteria

• 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.