Personalized Optimization of Systematic Prostate Biopsy

Not Applicable

Recruiting

• Conditions: Prostate Adenocarcinoma
• Interventions: Procedure: Personalized Optimization of Systematic Prostate Biopsy

• Registration Number: NCT05998278
• Lead Sponsor: Fujian Medical University Union Hospital

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 targeted biopsy combined 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 either the intervention or control group in a 1:1 ratio using SPSS software by a research nurse with no clinical involvement in the trial. 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 targeted biopsy combined 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.

Study Timeline

• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-18
• Study Start: 2023-08-23
• Status Verified: 2024-11
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 664

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Personalized Optimization of Systematic Prostate Biopsy	Experimental group received targeted biopsy plus personalized systematic biopsy

Primary Outcome Measures

Name	Time	Method
The detection rate of prostate cancer.	3 months after biopsy	According to the pathological results after biopsy, the detection rate of prostate cancer was calculated.

Trial Locations

Locations (1)

Department of Urology, Fujian Union Hospital, Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China