PSMA PET/CT-Guided Prostate Biopsy Outperforms mpMRI Cognitive-Fusion TRUS Biopsy in PI-RADS 4–5 Lesions

Single-center RCT: [68Ga]Ga-PSMA-11 PET/CT-guided robotic biopsy detected prostate cancer in 97.1% of PI-RADS 4–5 men vs 81.0% with mpMRI cognitive-fusion TRUS biopsy (P<0.05), and had far fewer complications (10.8% vs 51.4%, P<0.01).

• Prospective single-center RCT (NCT05137561); 217 biopsy-naïve men with PI-RADS ≥4 randomized to PSMA PET/CT-guided biopsy (n=112) vs mpMRI cognitive-fusion TRUS biopsy (n=105); ages 50–90, PSA ≥4 ng/mL.
• PSMA PET-guided biopsy yielded higher core positivity (60% ± 20% vs not reported for MCFB) despite fewer cores taken; major complications occurred in the MCFB arm only (n=5); median pain VAS 3 vs 5 favoring PSMA approach.
• Key limitation: single-center design limits generalizability; PI-RADS 5 subgroup difference (100% vs 95.1%) did not reach significance (P=0.09); PSMA PET availability and cost are real-world barriers not addressed.

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