Microultrasonography Rivals MRI in Prostate Cancer Detection

TOPLINE:

High-resolution microultrasonography-guided biopsy was non-inferior to MRI fusion-guided biopsy for detecting clinically significant prostate cancer (detection rates, 47.1% and 42.6%, respectively), a new trial showed.

METHODOLOGY:

• This multicentre, open-label, randomised, non-inferiority trial across eight countries, conducted from 2021 to 2024, included biopsy-naive adult men with clinical suspicion of prostate cancer due to elevated prostate-specific antigen levels or abnormal findings on digital rectal examination, who were indicated for biopsy.
• Participants were randomly assigned to receive microultrasonography-guided biopsy (n = 121), microultrasonography/MRI fusion-guided biopsy (n = 226), or MRI/conventional ultrasonography fusion-guided biopsy (n = 331).
• The primary outcome was the difference in the detection of clinically significant (Gleason Grade Group, ≥ 2) prostate cancers between microultrasonography plus systematic biopsy and MRI/conventional ultrasonography plus systematic biopsy.
• The secondary outcome was the difference in the detection of clinically significant prostate cancers between combined microultrasonography/MRI fusion-guided biopsy and MRI/conventional ultrasonography fusion-guided biopsy.

TAKEAWAY:

• Microultrasonography fusion-guided biopsy was non-inferior to MRI/conventional ultrasonography fusion-guided biopsy (difference, 3.52%; P < .001) in detecting Gleason Grade Group ≥ 2 cancers. The per-protocol analysis yielded similar results.
• Combined microultrasonography/MRI fusion-guided biopsy was also non-inferior to MRI/conventional ultrasonography fusion-guided biopsy (difference, 4.29%; P < .001). The per-protocol analysis yielded similar results.
• Targeted biopsy–only detection rates were not significantly different between the microultrasonography, MRI/conventional ultrasonography, and microultrasonography/MRI groups.
• MRI identified seven cases of clinically significant prostate cancer missed by microultrasonography, and microultrasonography detected seven cases missed by MRI. Clinically significant cancer was detected in 8.8% of patients when both imaging test results were negative, whereas it was detected in 73.6% of patients when both test results were positive.

IN PRACTICE:

“Microultrasonography may provide an alternative to MRI for image-guided prostate biopsy. For regions with limited MRI access, microultrasonography represents an imaging and biopsy technique that omits the accessibility and resource limitations of MRI capabilities,” the authors wrote.

SOURCE:

The study was led by Adam Kinnaird, MD, PhD, University of Alberta, Edmonton, Alberta, Canada. It was published online on March 23, 2025, in JAMA.

LIMITATIONS:

Biopsy was mandated for all participants, unlike current clinical practice. Systematic biopsy in all participants simplified the trial design but may not have reflected regional practices. The open-label design meant that biopsy techniques were not blinded, and MRI/ultrasonography fusion devices differed across sites. The study included only biopsy-naive men, limiting its applicability to other clinical scenarios such as active surveillance or prior negative biopsies. Additionally, microultrasonography is a newer modality that has been studied and implemented less extensively than MRI, highlighting the need for further research on its use, advancements, and operator variability.

DISCLOSURES:

This trial was funded by Exact Imaging. Several authors reported receiving personal fees, stock options, or non-financial support from various sources. Details are provided in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.