Optimizing Prostate Biopsy Schemes in Men With Multiple mpMRI Visible Lesions

NARecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

January 31, 2026

Study Completion Date

April 30, 2026

Conditions
Prostate Cancer
Interventions
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.

Trial Locations (1)

100034

RECRUITING

Peking University First Hospital, Beijing

All Listed Sponsors
lead

Peking University First Hospital

OTHER