A head-to-head comparison of sextant-systematic biopsy vs. extended-systematic biopsy for prostate cancer diagnosis in the era of MRI-targeted biopsy: SEXTANT-PRO non-inferiority randomized clinical trial.

ABSTRACT:

Background

In recent years, combined MRI-targeted biopsy (TB) and 12-core extended systematic biopsy (SB) (TB + 12SB) has been recommended for biopsy-naïve patients with MRI-visible lesions for prostate cancer (PCa) diagnosis. However, extended biopsy increases complication burden and healthcare expenditure. This head-to-head RCT aims to compare the novel combined MRI-TB and sextant six-core SB (TB + 6SB) scheme and classical TB + 12SB for PCa diagnosis.

Methods

From December 2024 to June 2025, this single-center non-inferiority RCT (NCT06684652) consecutively enrolled 506 biopsy-naïve men with single suspicious lesion on prostate mpMRI. Patients were randomized to undergo TB + 12SB (n = 252) or TB + 6SB (n = 254) through transperineal cognitive fusion technique. The study o

SUBMITTER: Deng R 

PROVIDER: S-EPMC12661352 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature