Optimizing Prostate Biopsy Schemes in Men With Multiple mpMRI Visible Lesions
Optimizing Prostate Biopsy Schemes in Men With Multiple mpMRI Visible Lesions: a Randomized Controlled Trial Evaluating the Efficacy of Perilesional/Regional Biopsy in Prostate Cancer Diagnosis Among Men With Multiple mpMRI Visible Lesions
Peking University First Hospital
400 participants
Feb 1, 2025
INTERVENTIONAL
Conditions
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 mpMRI visible lesions, including combination of targeted and perilesional/regional biopsy (PB/RB) (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 mpMRI visible lesions? What's the value of TPLBx in improving the evaluation of prostate cancer when developing the treatment plan for patients with multiple mpMRI visible lesions? What's the value of TPLBx in avoiding the adverse pathological outcomes after the radical prostatectomy such as upgrade, upstage, capsule invasion, and positive surgical margin among patients with multiple mpMRI visible lesions? Researchers will compare the cancer detection rates of TPLBx and CTSBx to explore the efficacy of different prostate biopsy schemes. They will evaluate the occurrence rates of adverse pathological changes of different prostate biopsy schemes after the radical prostatectomy (RP). Participants will: Receive TPLBx or CTSBx.
Eligibility
Plain Language Summary
Simplified for easier understanding
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
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 following a test dose 30 min before the procedure. Each patient is placed in the lithotomy position. Povidone-iodine is routinely used to clean perineum before the biopsy. The MRI-TRUS biopsy system is iFUSS (image fusion surgical system, Carbon Med), consisting of a 3D reconstruction and planning software (Carbon Med) and a bi-planar TRUS probe (ECL8-4-B, Carbon Med). Color Doppler examination is performed from the base to the apex. For each predefined mpMRI suspicious lesion, two-core TBs are obtained within the ROI, followed by ring-distributed four 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.
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 following a test dose 30 min before the procedure. Each patient is placed in the lithotomy position. Povidone-iodine is routinely used to clean perineum before the biopsy. The MRI-TRUS biopsy system is iFUSS (image fusion surgical system, Carbon Med), consisting of a 3D reconstruction and planning software (Carbon Med) and a bi-planar TRUS probe (ECL8-4-B, Carbon Med). Color Doppler examination is performed from the base to the apex. Two-core TBs from the lesion were performed within each predefined mpMRI suspicious lesion, followed by fore-zone 12-core biopsy.
Locations(1)
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NCT06841211