RecruitingNot ApplicableNCT07460843

Comparison of TB+PB and TB+6SB for Prostate Cancer Diagnosis

A Head-to-Head Comparison of Targeted and Perilesional Biopsy Versus Combination of Sextant-Systematic Biopsy and Targeted Biopsy for Prostate Cancer Diagnosis: A Randomized Controlled Trial

Sponsor

Peking University First Hospital

Enrollment

592 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer (Diagnosis)

Summary

The goal of this randomized controlled trial (RCT) is to evaluate the diagnostic efficacy of two novel prostate biopsy schemes, including targeted and perilesional biopsy (TB+PB) and combination of sextant-systematic biopsy and targeted biopsy (TB+6SB). The main questions it aims to answer are: Does TB+PB promote the accurate diagnosis of clinically significant prostate cancer (csPCa)? Could TB+6SB achieve the non-inferior diagnostic efficacy compared to TB+PB scheme? What's the value of TB+6SB in improving the detection of prostate cancer in the negative prostate lobe (contralateral to the index lesion)? In the era of MRI-targeted biopsy (TB), when TB and PB is effectively conducted and allows confident detection of the ROI, do we still need to perform SB? Researchers will compare the cancer detection rates of TB+PB and TB+SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the diagnostic profile of different prostate biopsy schemes through the spatial analysis of the prostate. Participants will: Receive TB+PB or TB+6SB.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different biopsy approaches for detecting prostate cancer. Both methods use MRI-targeted biopsy to find the suspicious area, but one also takes 6 additional random samples while the other takes a different number. The goal is to find out which approach is more accurate. **You may be eligible if...** - You are between 18 and 85 years old - You have not had a prostate biopsy before - You have a single suspicious area found on a prostate MRI scan - Your MRI shows a suspicious lesion rated 3 or higher (on the PI-RADS scale) - Your PSA level or prostate exam results suggest a biopsy is recommended **You may NOT be eligible if...** - You have had a prostate biopsy before - You have more than one suspicious area on MRI - Your MRI quality is too poor to evaluate 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 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. For patients in the TB+PB group, three-core TB was obtained within the predefined MRI suspicious lesion (ROI), followed by ring-distributed 6-core PB within a 10 to 15 mm radius around the ROI. The location of these nine cores depended on the shape and location of the suspicious lesion. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme.

PROCEDURETB+6SB

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. For patients in the TB+6SB group, three-core TB within the predefined mpMRI index lesion (ROI) was firstly performed. Then patients received six-core sextant-SB bilaterally with each side two cores in the peripheral zone and one core in the transitional zone. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme.