Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer

Summary

The goal of this multicenter randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes, including perilesional biopsy (PB) and combination of systematic biopsy and targeted biopsy (TB+SB).

The main questions it aims to answer are:

Does PB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of PB and TB+SB to explore the efficacy of different prostate biopsy schemes.

Participants will:

Receive TB+PB or TB+SB.

Conditions

• Prostate Cancer

Interventions

PROCEDURE

TB+PB

The biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. For each predefined MRI suspicious lesion, TB cores were obtained within each predefined MRI suspicious lesion (region of interest, ROI), followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depended on the shape and location of the suspicious lesion.

PROCEDURE

TB+SB

The biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. TB cores were obtained from the lesion, followed by 12-core SB.

Sponsors & Collaborators

• Beijing Hospital

  collaborator OTHER_GOV

• Shanghai East Hospital

  collaborator OTHER

• Beijing Friendship Hospital

  collaborator OTHER

• Chinese People's Liberation Army (PLA) General Hospital

  collaborator UNKNOWN

• Zhejiang Cancer Hospital

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• 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

45 Years

Max Age

85 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-01

Primary Completion

2026-09-30

Completion

2026-12-31

Countries

• China

Study Locations