Personalized Optimization of Systematic Prostate Biopsy

NCT05998278 | Recruiting DMC

• 1 other identifier: 2022WSJK030
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

Targeted biopsy combined systematic biopsy is the gold standard for diagnosis of prostate cancer. Excessive cores in systematic biopsy increases the risk of puncture trauma， bleeding and infection. On the basis of establishing a model with DRS stratification to reduce the cores of systematic biopsy, we propose the (12 cores -x) model innovatively. We hope that through this prospective study to verify the efficacy of the model and provide patients with a new biopsy model with high accuracy and fewer complications. In this study， patients with suspected prostate cancer were randomly divided into two groups. Experimental group received targeted biopsy combined personalized systematic biopsy, and the control group received systematic biopsy .The differences of the detection rate of Prostate cancer between the two groups were compared.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• The detection rate of clinically significant prostate cancer.

  According to the pathological results after biopsy, the detection rate of clinically significant prostate cancer (csPCa) was calculated.

  3 months after biopsy

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group received targeted biopsy plus personalized systematic biopsy

Procedure: Personalized Optimization of Systematic Prostate Biopsy

Control group

NO INTERVENTION

Control group received systematic biopsy

Interventions

Personalized Optimization of Systematic Prostate Biopsy PROCEDURE

Login the model based on our previous study (https://daringsky.shinyapps.io/prediction\_v2/) allows for input of age, BMI, serum PSA, size and location of suspicious lesions, PIRADS - V2 score, and prostate volume to generate an individualized needle distribution map,then targeted biopsy combined personalized optimization of systematic prostate biopsy was performed.

Experimental group

Eligibility Criteria

• Age: 50 Years - 95 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with lesions found on rectal examination with any PSA value;
• Patients with abnormal lesions found on imaging with any PSA value;
• PSA \>10.0 ng.ml-1;
• Patients with PSA of 4.0-10.0 ng.ml-1 and fPSA/tPSA \< 0.16; (5 ) mpMRI was performed prior to biopsy and Prostate Imaging Reporting and Data System (PI-RADS V2.1) assessment category ≥3
• (6) Willing to truthfully fill in the subject survey scale; (7) Willing to undergo follow-up; (8) The patient himself or his authorized immediate family member has signed the informed consent for clinical trial.

You may not qualify if:

• previous biopsy cases;
• Patients who have undergone prostate-related surgery, radiotherapy, or anti-androgen therapy;
• Patients whopresented with severe hemorrhoids or rectal stenosis, rendering them intolerant to transrectal ultrasound
• clotting disordersPatients with severe systemic diseases, such as cardiovascular and cerebrovascular disorders, are not appropriate candidates for surgical intervention.
• unable to follow the plan.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Department of Urology, Fujian Union Hospital, Fujian Medical University

Fuzhou, Fujian, 350000, China

RECRUITING

Related Publications (1)

• Chen Z, Qu M, Shen X, Jiang S, Zhang W, Ji J, Wang Y, Zhang J, Chen Z, Lin L, Li M, Wu C, Gao X. Establishment of an Individualized Predictive Model to Reduce the Core Number for Systematic Prostate Biopsy: A Dual Center Study Based on Stratification of the Disease Risk Score. Front Oncol. 2022 Feb 14;11:831603. doi: 10.3389/fonc.2021.831603. eCollection 2021.

  PMID: 35237503 BACKGROUND

Study Officials

• Zhenlin Chen

  Department of Urology, Fujian Union Hospital, Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiabing Zheng

CONTACT

+8613799422519; xhyykjk@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: They were randomly divided into two groups. One group received systematic biopsy. The other group received Targeted biopsy + personalized reduced-core biopsy .

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: August 18, 2023
• Study Start: August 23, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)