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

December 8, 2025 updated by: Ting Huang, Zhejiang University

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.

Study Overview

Status

Completed

Conditions

Prostate

Intervention / Treatment

Procedure: Prostate biopsy

Study Type

Observational

Enrollment (Actual)

436

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Zhejiang
  - Jinhua, Zhejiang, China, 321000
    - Jinhua Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

participants who presented MRI-visible lesions

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
detection rates of clinically significant prostate cancer Time Frame: 2022.01~2025.06	2022.01~2025.06

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

October 1, 2025

Study Registration Dates

First Submitted

November 23, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)