Clinical trial NCT06509919: Application of a Novel Biomarker Based on Plasma cfDNA Assay in the Early Diagnosis of Prostate Cancer
Official title: Application of a Model Based on Plasma cfDNA Fragmentomics in the Early Diagnosis of Prostate Cancer.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Elevated PSA
Biopsy
Prostate cancer
Prostate neoplasms
cfDNA
Machine learning
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: Ningbo No. 1 Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: Jiangsu Provincial People's Hospital
name: The First Affiliated Hospital of Soochow University
name: West China Hospital
name: Zhongda Hospital
name: Northern Jiangsu People's Hospital
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2024-07-19
Enrollment: 1100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male patients aged 18-80 with PSA tests score of 4-10 ng/ml and are scheduled for a prostate biopsy.

Brief summary: 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.


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.

Primary outcomes:
measure: AUROC value for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
timeFrame: Through completion of study and all data analysis which may take up to one and a half years.
measure: Sensitivity for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
timeFrame: Through completion of study and all data analysis which may take up to one and a half years.
measure: Specificity for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
timeFrame: Through completion of study and all data analysis which may take up to one and a half years.
Secondary outcomes:
measure: AUROC value for predicting clinically significant prostate cancer (GS > 7) in pathological results.
timeFrame: Through completion of study and all data analysis which may take up to one and a half years.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changzheng hospital
state: Shanghai
Study officials:
References: