KLK3 and prostate neoplasm: Sixty men (39 in the TRT group and 21 in the placebo group) had confirmed PSA concentrations greater than 4.0 ng/mL, 37 men (25 in the TRT group and 12 in the placebo group) had confirmed increases in PSA concentrations greater than 1.4 ng/mL above baseline during the first year (or >0.7 ng/mL for those taking 5ARIs), 5 men (4 in the TRT group and 1 in the placebo group) had a new prostate nodule or induration, and 1 man (in the TRT group) had a PSA concentration that increased from less than 1.5 ng/mL at baseline to greater than 3.0 ng/mL.