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Optimizing Prostate Biopsy Schemes in Men With Multiple MRI Visible Lesions

NCT06841211 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2026-06-11

No results posted yet for this study

Summary

The goal of this randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes in prostate cancer diagnosis among men with multiple MRI visible lesions, including combination of targeted and perilesional (PB) (TPLBx) and combination of systematic biopsy and targeted biopsy (CTSBx).

The main questions it aims to answer are:

Does TPLBx promote the accurate diagnosis of clinically significant prostate cancer (csPCa) among men with multiple MRI visible lesions? What's the value of TPLBx in improving the evaluation of prostate cancer when developing the treatment plan for patients with multiple MRI visible lesions? What's the value of TPLBx in avoiding the adverse pathological outcomes after the radical prostatectomy such as upgrade, upstage, and capsule invasion among patients with multiple MRI visible lesions? Researchers will compare the cancer detection rates of TPLBx and CTSBx to explore the efficacy of different prostate biopsy schemes.

Participants will:

Receive TPLBx or CTSBx.

Conditions

Interventions

PROCEDURE

Targeted and perilesional biopsy (TPLBx)

The biopsy procedure is conducted by highly skilled and experienced urologists who specialize in performing prostate biopsies. A single dose of prophylactic antibiotics (usually cephalosporins) is routinely administered 30 min before the procedure. For each predefined MRI suspicious lesion, TBs are obtained within the ROI, followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depends on the shape and location of the suspicious lesion.

PROCEDURE

Combined targeted and systematic biopsy (CTSBx)

The biopsy procedure is conducted by highly skilled and experienced urologists who specialize in performing prostate biopsies. A single dose of prophylactic antibiotics (usually cephalosporins) is routinely administered 30 min before the procedure. TBs are performed within each predefined MRI suspicious lesion, followed by SB.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Yi LIU · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2026-08-31
Completion
2026-12-31

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 NCT06841211 on ClinicalTrials.gov