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Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer

NCT06482645 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-07-23

No results posted yet for this study

Summary

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

The main questions it aims to answer are:

Does PB/RSB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB/RSB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of PB/RSB and combination of TB+SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different prostate biopsy schemes through the complication rates and postoperative quality of life.

Participants will:

Receive PB/RSB or TB+SB.

Conditions

Interventions

PROCEDURE

Perilesional/regional systematic biopsy

The biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position or lithotomy position. For each predefined mpMRI suspicious lesion, urologists obtained nine cores at 5-mm intervals within and around the region of interest (penumbra). The location of these nine cores depended on the shape and location of the suspicious lesion.

PROCEDURE

Combination of systematic biopsy and targeted biopsy

The biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position or lithotomy position. The ultrasound equipment used included a color Doppler ultrasound diagnostic instrument (Hitachi HiVision, Philips Epiq 7), transrectal probes, and corresponding puncture needle guns. Color Doppler examination was performed from the base to the apex. Three to five targeted biopsies from the lesion were performed within and around the predefined mpMRI suspicious lesion, followed by fore-zone 12-core biopsy.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

  • Beijing Hospital

    collaborator OTHER_GOV

  • Shanghai East Hospital

    collaborator 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
2025-06-30
Completion
2026-06-30

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 NCT06482645 on ClinicalTrials.gov