NCT07296510

Is it Feasible to Use Data Obtained Through a Three-Dimensional Reconstructed Image to Assist in Prostate Targeted Biopsy?

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 436 (actual)
• Sponsor: Zhejiang University · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

Objectives:There are numerous auxiliary methods to improve the accuracy of pathology results regarding prostate biopsy. However, there is no consensus on how to achieve precise targeted biopsy. This paper explores whether using data obtained through the three-dimensional reconstructed image to locate biopsy points can assist in prostate targeted biopsy. Methods: This study is prospective. Between January 1, 2022, and June 30, 2025, our center conducted prostate biopsies on a total of 436 patients who met the criteria for prostate biopsy and exhibited suspicious lesions (PI-RADS 3-5), totaling 471 lesions. Prior to the biopsies, 3D Slicer software was utilized to perform three-dimensional reconstructions of the pelvic organs. Three-dimensional imaging was employed to measure the biopsy path data, guiding targeted biopsies. This study combined software-assisted targeted biopsies with systematic biopsies and conducted an analysis to assess the feasibility of this approach.

Conditions

• Prostate

Interventions

Type	Name	Description
PROCEDURE	Prostate biopsy	All participants underwent both targeted and systematic biopsies, along with three-dimensional reconstructed image-assisted prostate targeted biopsy,and software-assisted fusion targeted biopsy

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-06-30
• Completion: 2025-10-01
• First posted: 2025-12-22
• Last updated: 2025-12-22

Locations

1 site across 1 country: China