Personalized Optimization of Systematic Prostate Biopsy

NCT ID: NCT05998278

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-23
• Study Completion Date: 2025-12-30

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.

Detailed Description

In this study, patients with suspected prostate cancer were were enrolled at our institution, a public referral tertiary center. After written consent was obtained，Patients were randomly assigned to the intervention or control group in a 1:1 ratio by a research nurse who was not involved in the clinical study, using Computer-generated randomization method. Once the allocation was established, neither patients nor investigators, including the member of the study who collected the data related to infectious events later, were blinded. Prior to biopsy, the following patient characteristics were obtained: age, BMI, serum PSA levels, location and size of the region of interest, and PIRADS-V2 score. Biopsy was performed by an experienced urologist using standard transperineal technique. The patient was placed in the lithotomy position and underwent either general anesthesia or local anesthesia (15 ml of 5% lidocaine was injected into the prostate capsule and apex under ultrasound guidance after the ultrasound probe was inserted transrectally for local anesthesia). Patients assigned to the experimental group were informed of the personalized systematic biopsy combined with targeted biopsy using the (12 cores -x) model (https://daringsky.shinyapps.io/prediction_v2/)， and the control group received systematic biopsy. A biopsy core was obtained using an 18-gauge 25cm needle and a spring needle biopsy gun. The primary endpoint was the rate of prostate cancer diagnosis, including clinically significant cases. The secondary endpoints included pain scores and complications such as hematuria, perineal hematoma, urinary tract infection, and urinary retention.

An interim analysis is planned after approximately 50% of the target sample size has completed follow-up for the primary endpoint. The interim analysis aims to:

1. assess safety data to ensure participant protection, and

2. explore preliminary efficacy trends.

Conditions

Prostate Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Experimental group

Experimental group received targeted biopsy plus personalized systematic biopsy

Group Type: EXPERIMENTAL

Personalized Optimization of Systematic Prostate Biopsy

Intervention Type: 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.

Control group

Control group received systematic biopsy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Personalized Optimization of Systematic Prostate Biopsy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients with lesions found on rectal examination with any PSA value;

2. Patients with abnormal lesions found on imaging with any PSA value;

3. PSA >10.0 ng.ml-1;

4. 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.

Exclusion Criteria

1. previous biopsy cases;

2. Patients who have undergone prostate-related surgery, radiotherapy, or anti-androgen therapy;

3. Patients whopresented with severe hemorrhoids or rectal stenosis, rendering them intolerant to transrectal ultrasound

4. clotting disordersPatients with severe systemic diseases, such as cardiovascular and cerebrovascular disorders, are not appropriate candidates for surgical intervention.

5. unable to follow the plan.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University Union Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhenlin Chen

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, Fujian Union Hospital, Fujian Medical University

Locations

Department of Urology, Fujian Union Hospital, Fujian Medical University

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiabing Zheng

Role: CONTACT

Phone: +8613799422519

Email: xhyykjk@163.com

Facility Contacts

Jiabing Zheng

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 35237503 (View on PubMed)

Other Identifiers

2022WSJK030

Identifier Type: -

Identifier Source: org_study_id