NCT06841211

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prostate biopsies have been the cornerstone of prostate cancer (PCa) diagnosis, risk stratification, and treatment planning. The optimal biopsy scheme should achieve the highest csPCa detection rates with the most accurate core sites and the least biopsy-cores. The combined targeted and systematic biopsy (CTSBx) could effectively detect clinically significant PCa (csPCa) and was the standard scheme for patients with visible suspicious lesions on multiparametric MRI (mpMRI) in the past. However, some limitations existed in the CTSBx scheme, including the detection of clinically insignificant PCa (ciPCa), the risk of post-biopsy complications, and adverse pathological changes such as upgrade, upstage, capsule invasion, and positive surgical margin after the radical prostatectomy (RP). Therefore, more and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Recent studies demonstrated that the majority of csPCa were found within a band of 10-mm radius outside MRI lesions (the penumbra). Focusing biopsy cores within and around the region of interest (ROI), known as targeted and perilesional biopsy (TPLBx) scheme, is recommended by the latest EAU guideline for the diagnosis of patients with visible suspicious lesions on multiparametric MRI (mpMRI). Prostate cancer generally occurs multifocally. The incidence of multiple lesions among different cohorts in previous studies ranges between 20% and 50%. Though the CTSBx schemes are usually utilized for these patients, some previous studies suggested that additional systematic biopsy is of limited informative value in terms of overall csPCa detection. Therefore, the optimal prostate biopsy scheme for patients with multiple visible mpMRI suspicious lesions is still a matter of debate. Compared with the CTSBx scheme, the TPLBx changed the distribution of the biopsy-core according to the location of visible suspicious lesions. Many studies have preliminarily verified that the diagnostic efficacy of TPLBx was not inferior to that of CTSBx with the benefits of decreasing the detection of ciPCa and reducing biopsy cores. TPLBx scheme focuses biopsy cores within and around the ROI, which may evaluate the pathological characteristics of mpMRI visible suspicious lesions more accurately, benefiting for the treatment planning and reducing the occurrence rates of adverse pathological changes after the radical prostatectomy (RP). However, current data for TPLBx schemes are mostly retrospective, and few studies focused on the application of TPLBx for patients with multiple mpMRI visible lesions. Thus, this randomized controlled trial (RCT) aims to evaluate the efficacy of TPLBx and CTSBx schemes for patients with multiple mpMRI visible lesions, provide high-quality evidence for the optimization of prostate biopsy schemes. 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Targeted 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 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.
PROCEDURE	Combined targeted and systematic biopsy (CTSBx)	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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-01-31
• Completion: 2026-04-30
• First posted: 2025-02-24
• Last updated: 2025-02-25

Locations

1 site across 1 country: China