Development of an Intraoperative Adaptive Biopsy System for Prostate Cancer: Integrating Imaging Navigation With Metabolic Feedback for Dynamic Decision-Making

September 27, 2026 updated by: Hang Wang, Shanghai Zhongshan Hospital

An MRI-Based Diagnostic Model for Prostate Cancer Localization: An Exploratory Study Integrating Radiomics and the Metabolic Microenvironment

Development of an Intelligent System Integrating Preoperative Imaging and Real-Time Intraoperative Metabolic Feedback to Dynamically Optimize Biopsy core Placement for Individualized Precision Sampling.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

90

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
      • Shanghai, China
        • Recruiting
        • Shanghai Geriatric Medical Center
        • Contact:
          • Shanghai Geriatric Medical Center
          • Phone Number: +86 51371990
          • Email: zsurology@126.com
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
      • Shanghai, China
        • Recruiting
        • Minhang Hospital, Fudan University
        • Contact:
      • Shanghai, China
        • Recruiting
        • Xuhui Hospital, Fudan University
        • Contact:

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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent prostate biopsy at three medical centers in Shanghai: Minhang Hospital, Fudan University; Xuhui Hospital, Fudan University and Shanghai Geriatric Medical Center

Description

Inclusion Criteria:

  1. Age ≥55 years;
  2. Indication for prostate biopsy;
  3. Availability of total prostate-specific antigen (tPSA), free PSA (fPSA) levels, and multiparametric MRI (mpMRI) results within 1 month prior to biopsy.

Exclusion Criteria:

  1. Pathological diagnosis of malignancies other than prostatic acinar adenocarcinoma;
  2. Concomitant malignant tumors potentially affecting imaging findings (e.g., rectal, bladder, or testicular cancer);
  3. Cachexia or organ function decompensation.

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

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Adaptive Biopsy Group

Adaptive dynamic biopsy is performed using an intelligent system integrating preoperative imaging data with real-time intraoperative metabolic feedback.
Systemic Biopsy Group

A 10-12-core systematic biopsy.
mpMRI Fusion Targeted Biopsy Group

mpMRI-US fusion-guided targeted prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean number of biopsy cores required to achieve a definitive diagnosis in the adaptive biopsy group
Time Frame: After 8 weeks of the enrollment process was completed
After 8 weeks of the enrollment process was completed

Secondary Outcome Measures

Outcome Measure
Time Frame
Prostate cancer detection rate
Time Frame: After 8 weeks of the enrollment process was completed
After 8 weeks of the enrollment process was completed
Missed diagnosis rates in the adaptive biopsy group and the mpMRI-US fusion-targeted biopsy group
Time Frame: After 8 weeks of the enrollment process was completed
After 8 weeks of the enrollment process was completed
The time of biopsy
Time Frame: After 8 weeks of the enrollment process was completed
After 8 weeks of the enrollment process was completed
Complication rate
Time Frame: After 8 weeks of the enrollment process was completed
After 8 weeks of the enrollment process was completed

Collaborators and Investigators

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

Sponsor

Shanghai Zhongshan Hospital

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)

July 21, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

September 27, 2026

First Submitted That Met QC Criteria

September 27, 2026

First Posted (Actual)

October 2, 2026

Study Record Updates

Last Update Posted (Actual)

October 2, 2026

Last Update Submitted That Met QC Criteria

September 27, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-006-01K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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