Consistent with the higher diagnostic rate of TR approach in patients with PSA > 20 ng/mL reported in the literature [17], the TR group had a higher positive rate of biopsy cores among the patients with T3 and T4 stages (72.4% vs 62.5%, OR: 1.573, p = 0.001) in our study, which suggested that TR approach may have advantage in patients with a probable diagnosis of high-risk prostate cancer (PSA levels > 20 ng/mL, cT3–T4 stage tumor on imaging or digital rectal examination). This evidence concerns the gene KLK3 and neoplasm.