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

NCT07296510 | Completed

• 1 other identifier: 2021120
• Study Type: observational
• Target: 436
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• detection rates of clinically significant prostate cancer

  2022.01~2025.06

Interventions

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

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

participants who presented MRI-visible lesions

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Jinhua Hospital, Zhejiang University School of Medicine

Jinhua, Zhejiang, 321000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Prostate Biopsy

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 22, 2025
• Study Start: January 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: October 1, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

CN (1)