Top Line: Can PSMA PET help identify patients being worked up for prostate cancer who could avoid biopsy?
The Study: MRI is now widely used in the workup of potential prostate cancer to identify patients with clinically significant disease. However, some patients with no clinically significant lesions may still undergo biopsy due to other high risk features. PRIMARY 2 was a phase 3 trial that included 660 biopsy-naive men being worked up for possible prostate cancer who had PIRADS2 or PIRADS3 findings on MRI and at least one of the following high risk features: PSA density >0.1, abnormal DRE, family history, or BRCA mutation. They were randomized to 68Ga-PSMA-11 PET-CT or systematic transperineal biopsy. In the experimental arm, those with a positive PET went on to targeted biopsy and those with a negative PET continued PSA surveillance. Clinically significant cancer (Gleason 3+4 with ≥10% pattern 4 or higher) was found in 12% in the PET arm versus 16% in the biopsy arm, which was deemed non-inferior. PSMA-PET spared biopsy in 49% and roughly halved the rate of finding insignificant cancer (14% vs 32%).
TBL: In high-risk men with non-suspicious or equivocal MRI, 68Ga-PSMA PET was non-inferior at detecting clinically significant prostate cancer while letting nearly half of patients avoid biopsy. | Buteau, Lancet Oncol 2026
The Study: MRI is now widely used in the workup of potential prostate cancer to identify patients with clinically significant disease. However, some patients with no clinically significant lesions may still undergo biopsy due to other high risk features. PRIMARY 2 was a phase 3 trial that included 660 biopsy-naive men being worked up for possible prostate cancer who had PIRADS2 or PIRADS3 findings on MRI and at least one of the following high risk features: PSA density >0.1, abnormal DRE, family history, or BRCA mutation. They were randomized to 68Ga-PSMA-11 PET-CT or systematic transperineal biopsy. In the experimental arm, those with a positive PET went on to targeted biopsy and those with a negative PET continued PSA surveillance. Clinically significant cancer (Gleason 3+4 with ≥10% pattern 4 or higher) was found in 12% in the PET arm versus 16% in the biopsy arm, which was deemed non-inferior. PSMA-PET spared biopsy in 49% and roughly halved the rate of finding insignificant cancer (14% vs 32%).
TBL: In high-risk men with non-suspicious or equivocal MRI, 68Ga-PSMA PET was non-inferior at detecting clinically significant prostate cancer while letting nearly half of patients avoid biopsy. | Buteau, Lancet Oncol 2026