Other Secondary Prostate Safety End Points
acute urinary retention, prostate
INDURATION, PROSTATE NODULE, PROSTATE
Twenty testosterone-treated men (0.77%) and 16 placebo-treated men (0.61%) developed acute urinary retention, with no significant difference between groups (HR, 1.25; 95% CI, 0.65-2.41; Eighty-five men (1.6%) met the criteria for referral for urologic evaluation, 57 (2.2%) in the TRT group vs 28 (1.1%) in the placebo group. 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.Of the 85 men who met the criteria for urologic referral, 16 (18.8%) elected to undergo prostate biopsy; an additional 14 men who did not meet these criteria also underwent biopsy. The numbers of prostate biopsies (16 in the TRT group vs 14 in the placebo group) did not differ between groups (0.62% vs 0.54%; HR, 1.13; 95% CI, 0.55-2.31; 