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The Value of Dual-parametric Magnetic Resonance Combined With Regional Saturation Biopsy in Patients With Suspected Prostate Cancer

NCT06824259 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-08-21

No results posted yet for this study

Summary

The aim of this study was to investigate the value of dual-parameter magnetic resonance imaging(bpMRI) combined with regional saturation biopsy in the diagnosis of prostate cancer by means of a prospective randomized controlled study.

The main questions it aims to answer are:

Can bpMRI guide the timing of prostate puncture and avoid unnecessary prostate biopsy? Effectiveness of focal saturation biopsy versus systemic biopsy + targeted biopsy.

Conditions

Interventions

PROCEDURE

Follow up if MRI is negative

Enter the follow-up cohort without systematic biopsy when prostate cancer is clinically suspected and no PIRADS v2.1 score ≥3 lesions are detected on initial examination. MR plus regional saturation biopsy was performed when MRI progressed.

PROCEDURE

Systematic biopsy if MRI is negative

Systematic biopsy was performed if there was clinical suspicion of prostate cancer and no PIRADS v2.1 score ≥3 lesions were detected on initial examination. If the biopsy was negative enter the follow-up cohort.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-14
Primary Completion
2027-12-31
Completion
2029-06-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06824259 on ClinicalTrials.gov