Development of an Intraoperative Adaptive Biopsy System for Prostate Cancer: Integrating Imaging Navigation With Metabolic Feedback for Dynamic Decision-Making
An MRI-Based Diagnostic Model for Prostate Cancer Localization: An Exploratory Study Integrating Radiomics and the Metabolic Microenvironment
1 other identifier
observational
90
1 country
4
Brief Summary
Development of an Intelligent System Integrating Preoperative Imaging and Real-Time Intraoperative Metabolic Feedback to Dynamically Optimize Biopsy core Placement for Individualized Precision Sampling.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2026
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 21, 2026
CompletedFirst Submitted
Initial submission to the registry
September 27, 2026
CompletedFirst Posted
Study publicly available on registry
October 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
October 2, 2026
September 1, 2026
1.1 years
September 27, 2026
September 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Mean number of biopsy cores required to achieve a definitive diagnosis in the adaptive biopsy group
After 8 weeks of the enrollment process was completed
Secondary Outcomes (4)
Prostate cancer detection rate
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
After 8 weeks of the enrollment process was completed
The time of biopsy
After 8 weeks of the enrollment process was completed
Complication rate
After 8 weeks of the enrollment process was completed
Study Arms (3)
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
Eligibility Criteria
Patients who underwent prostate biopsy at three medical centers in Shanghai: Minhang Hospital, Fudan University; Xuhui Hospital, Fudan University and Shanghai Geriatric Medical Center
You may qualify if:
- Age ≥55 years;
- Indication for prostate biopsy;
- Availability of total prostate-specific antigen (tPSA), free PSA (fPSA) levels, and multiparametric MRI (mpMRI) results within 1 month prior to biopsy.
You may not qualify if:
- Pathological diagnosis of malignancies other than prostatic acinar adenocarcinoma;
- Concomitant malignant tumors potentially affecting imaging findings (e.g., rectal, bladder, or testicular cancer);
- Cachexia or organ function decompensation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Minhang Hospital, Fudan University
Shanghai, China
Shanghai Geriatric Medical Center
Shanghai, China
Xuhui Hospital, Fudan University
Shanghai, China
Zhongshan Hospital, Fudan University
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 27, 2026
First Posted
October 2, 2026
Study Start
July 21, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2028
Last Updated
October 2, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share