A prospective study on inter-operator variability in semi-robotic software-based MRI/TRUS-fusion targeted prostate...

Area of Science:

• Urology
• Medical Imaging
• Oncology

Background:

• Magnetic resonance imaging (MRI)/ultrasound-fusion biopsy (FB) is a multi-step procedure.
• Each step in FB can impact targeted biopsy (TB) accuracy, potentially leading to false-negative results.
• Understanding inter-operator variability is crucial for optimizing TB accuracy.

Purpose of the Study:

• To assess the inter-operator variability of software-based fusion TB.
• To evaluate the impact of different urologists targeting the same MRI-visible lesions.
• To identify factors contributing to variability in TB accuracy.

Main Methods:

• Prospective study involving 142 patients and 31 urologists.
• Software-based FB performed by two different urologists per patient on 172 lesions.
• Analysis of mismatches in detecting overall prostate cancer (PCa) and clinically significant PCa (csPCa) between the two biopsies.
• Uni- and multivariable analyses to identify factors influencing variability.

Main Results:

• A mismatch in overall PCa detection between the two biopsies occurred in 11.6% of lesions (10.6% of patients).
• Patient-based mismatch for csPCa detection was observed in 14.8% of cases.
• Smaller lesion size was a significant predictor of biopsy mismatches (OR 9.19, p < 0.001).
• No significant difference in PCa or csPCa detection rates between the two urologists was found.

Conclusions:

• Reproducibility and precision in targeting, especially for small lesions, remain limited with current software-based FB techniques.
• Further advancements in image fusion, segmentation, and needle-guidance systems are necessary.
• Automation in the FB process may help improve consistency and accuracy.