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PRIMARY2: PSMA-PET avoided biopsy in 49% of men while staying non-inferior for csPCa detection (12% vs 16%) vs systematic biopsy in high-risk equivocal-MRI men.
Prostate carried the day's only signal, and it's diagnostic, not therapeutic. PRIMARY2, a phase 3 RCT, backs the PSMA-PET PRIMARY-score pathway as a biopsy-avoidance gate, sparing biopsy in ~49% of biopsy-naive high-risk men with equivocal MRI while holding non-inferior csPCa detection. Wide 10% NI margin and immature follow-up temper the read.
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- PRIMARY2PSMA-PET avoided biopsy in 49% while staying non-inferior for csPCa detection (12% vs 16%) vs systematic biopsy in high-risk equivocal-MRI men.
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