Abstract
Positron emission tomography (PET) radiotracers that target prostate-specific membrane antigen (PSMA), a transmembrane protein overexpressed in prostate cancer (PCa) cells, are highly sensitive and specific for the detection of metastatic PCa. The radioactive PET imaging agent Ga-68 PSMA-11 has demonstrated higher PCa detection rates compared with conventional imaging techniques, leading to its increased use in the diagnosis of PCa. In this review of literature published between February 2015 and December 2022, of 76 studies in >5000 men with PCa, we examined the accuracy and clinical use of Ga-68 PSMA-11 PET for the initial staging of PCa, assessment of biochemical recurrence (BCR), and how this technique may affect the clinical management of PCa. The majority of studies evaluating Ga-68 PSMA-11 PET for primary staging and for BCR demonstrated a sensitivity >80% and a specificity >90%. Ga-68 PSMA-11 PET led to a change in clinical management in 19% to 52% and 16% to 75% of patients with primary PCa and BCR, respectively. Variations in diagnostic accuracy parameters were observed among studies but were anticipated given differences in patient characteristics (eg, PSA, lesion sizes) and study designs. No serious adverse events were noted with Ga-68 PSMA-11 PET. Overall, Ga-68 PSMA-11 offers high sensitivity, is well tolerated, and can result in clinical management changes for patients with primary PCa and BCR.