Early diagnosis is important in the overall management of prostate cancer (PCa). Gallium-68-labeled prostate-specific membrane antigen (PSMA) PET/CT has an established role in the detection of recurrent disease and staging of patients with intermediate- to high-risk PCa. However, only a small number of studies have evaluated its role in the initial diagnosis of PCa. This systematic review was conducted to evaluate the diagnostic performance of Ga-PSMA PET/CT in the initial detection of PCa in patients with clinical or biochemical findings suspicious for PCa. This systematic review followed PRISMA guidelines. Searches in PubMed, Scopus, and Embase were conducted using relevant keywords, and articles published through April 30, 2020, were included. Using histopathology results as the reference standard, the numbers of true- and false-positives and true- and false-negatives were extracted. Pooled estimates of diagnostic test accuracy-including sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and summary ROC (SROC) curve-were generated using bivariate random-effects meta-analysis. Seven studies comprising 389 patients were included in the systematic review and meta-analysis. The pooled sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio for the initial diagnosis of PCa using Ga-PSMA PET/CT were 0.97 (95% CI, 0.90-0.99), 0.66 (95% CI, 0.52-0.78), 2.86 (95% CI, 1.95-4.20), and 0.05 (95% CI, 0.01-0.15), respectively. The test had high accuracy; the area under the SROC curve was 0.91 (95% CI, 0.88-0.93). Gallium-68-labeled PSMA PET/CT had excellent sensitivity and negative likelihood ratio in the initial diagnosis of PCa in patients with clinical or biochemical findings suspicious for PCa. Gallium-68-labeled PSMA PET/CT had high diagnostic accuracy for the initial detection of PCa in patients with clinical or biochemical findings suspicious for PCa and has potential utility as a rule-out test for these patients.