PCa Detection in PI-RADS 4 and 5 Lesions: Comparison of [ 68 Ga]Ga-PSMA-11 PET/CT-Guided Robot-Assisted Biopsy Versus mpMRI Cognitive-Fusion TRUS-Guided Prostate Biopsy.
J Nucl MedSep 2, 2026 (epub)
Rajender Kumar, Aravindh Ram, Santosh Kumar et al.
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In 30 seconds
This randomized controlled trial compared the diagnostic performance of robotic arm-assisted [68Ga]Ga-PSMA-11 PET/CT-guided prostate biopsy (PGPB) with mpMRI-directed cognitive-fusion transrectal ultrasound-guided biopsy (MCFB) in biopsy-naïve men with suspected prostate cancer. Among 267 participants, PCa was detected in 97.1% of those undergoing PGPB versus 81.0% with MCFB (P < 0.05).
Key findings
- PCa detection rate was 97.1% in the PGPB group compared to 81.0% in the MCFB group (P < 0.05).
- PGPB showed a higher diagnostic accuracy for PI-RADS 5 lesions at 100% versus 95.1% for MCFB (P = 0.09).
- Arm 1 had significantly fewer complications at 10.8% compared to 51.4% in arm 2 (P < 0.01).
- The median pain score was lower in arm 1 at 3 versus 5 in arm 2.
Why it matters
The study highlights the superior diagnostic performance and safety profile of [68Ga]Ga-PSMA-11 PET/CT-guided biopsy over traditional methods, which may influence clinical decision-making in prostate cancer diagnosis and management.