NCT06824259

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

The Value of Dual-parametric Magnetic Resonance Combined With Regional Saturation Biopsy in Diagnostic Decision-making in Patients With Suspected Prostate cancer--a Single-center Prospective Randomized Controlled Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-14
• Primary completion: 2027-12-31
• Completion: 2029-06-30
• First posted: 2025-02-13
• Last updated: 2025-08-21

Locations

1 site across 1 country: China