RecruitingNot ApplicableNCT06841211

Optimizing Prostate Biopsy Schemes in Men With Multiple MRI Visible Lesions

Optimizing Prostate Biopsy Schemes in Men With Multiple MRI Visible Lesions: a Randomized Controlled Trial Evaluating the Efficacy of Perilesional Biopsy in Prostate Cancer Diagnosis

Sponsor

Peking University First Hospital

Enrollment

572 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different biopsy strategies for men who have multiple suspicious areas visible on a prostate MRI scan, to figure out the most accurate and least invasive way to diagnose prostate cancer when more than one area looks abnormal. **You may be eligible if...** - You are between 18 and 85 years old - You have never had a prostate biopsy before - You have multiple suspicious areas on a high-quality prostate MRI scan - Your PSA (prostate-specific antigen) blood test is less than 50 ng/mL **You may NOT be eligible if...** - You have a contraindication to MRI (e.g., a pacemaker or certain metal implants) - Your MRI scan is of poor quality - The time between your MRI and biopsy is more than one month - You are on blood thinners or have bleeding disorders that would make biopsy unsafe 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

PROCEDURETargeted 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.

PROCEDURECombined targeted and systematic biopsy (CTSBx)