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

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.

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Key information

Conditions

Prostate

Sex eligibility

Male

Study type

Observational

Primary location

Jinhua Hospital, Zhejiang University School of Medicine

Jinhua, Zhejiang, 321000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients meet the criteria for prostate biopsy and exhibited suspicious lesions (PI-RADS 3-5)

Exclusion criteria

Patients with advanced prostate cancer and those with severe coagulopathy or other conditions unsuitable for prostate biopsy

Treatment and study plan

Prostate biopsy

Procedure

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

Primary outcomes

detection rates of clinically significant prostate cancer

Time frame: 2022.01~2025.06

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Dec 22, 2025
Registry last updated: Dec 22, 2025

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View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed