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

Application of a Model Based on Plasma cfDNA Fragmentomics in the Early Diagnosis of Prostate Cancer.

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: Blood draw

• Study Type: Observational
• Enrollment (Estimated): 1100

Contacts and Locations

• Study Contact: Name: Shancheng Ren, MD,PhD; Phone Number: 139 1779 3885; Email: renshancheng@gmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201109
      • Recruiting
      • Changzheng hospital
      • Contact: Shancheng Ren, PhD; Phone Number: 13917793885; Email: renshancheng@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with elevated PSA test results (4-10ng/ml)	Diagnostic test: Blood draw; Before undergoing a prostate biopsy, participants will have about 10 mLs of venous blood drawn. Blood will be sent to Geneseeq Technology Inc. for whole genome high-throughput sequencing of plasma cfDNA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUROC value for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.	Through completion of study and all data analysis which may take up to one and a half years.
Sensitivity for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.	Through completion of study and all data analysis which may take up to one and a half years.
Specificity for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.	Through completion of study and all data analysis which may take up to one and a half years.

Secondary Outcome Measures

Outcome Measure	Time Frame
AUROC value for predicting clinically significant prostate cancer (GS > 7) in pathological results.	Through completion of study and all data analysis which may take up to one and a half years.

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; West China Hospital; The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Guangzhou Medical University; Zhongda Hospital; Ningbo No. 1 Hospital; Jiangsu Provincial People's Hospital; Northern Jiangsu People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 14, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Prostate cancer; Biopsy; Prostate neoplasms; cfDNA; Machine learning; Elevated PSA
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: KAL1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No