NCT05998278

Personalized Optimization of Systematic Prostate Biopsy

Diagnostic Performance of a Individualized Reduced-Core Biopsy Strategy in Prostate Cancer: A Prospective, Randomized Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Fujian Medical University Union Hospital · Academic / Other
• Sex: Male
• Age: 50 Years – 95 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2023-08-23
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-08-18
• Last updated: 2025-12-18

Locations

1 site across 1 country: China