RecruitingNot ApplicableNCT06482645

Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer

Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer: a Multicenter Randomized Controlled Trial

Sponsor

Peking University First Hospital

Enrollment

640 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Sex: MALEMin Age: 45 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether taking a biopsy from the area immediately around a suspicious prostate lesion (called a perilesional biopsy) — rather than just the lesion itself — can improve prostate cancer detection rates. This could help catch cancers that might be missed by standard biopsy techniques. **You may be eligible if...** - You are between 45 and 85 years old - You have not had a prostate biopsy before - You have a single suspicious lesion on MRI (PI-RADS score above 3) with good image quality - You have an elevated PSA level or other signs that indicate a biopsy is needed - Your biopsy results and imaging data are complete **You may NOT be eligible if...** - You have had a previous prostate biopsy - You have multiple suspicious lesions - Your MRI images are of poor quality Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETB+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.

PROCEDURETB+SB