Prostate Safety Monitoring Plan
testosterone-induced increase, prostate
INDURATION, PROSTATE NODULE, PROSTATE
The prespecified prostate safety monitoring plan is provided in To minimize the ascertainment bias attributable to the increased risk of being referred for a prostate biopsy because of testosterone-induced increase in PSA levels, the criteria for urologic referral were prespecified. The participants were referred for urologic evaluation and possible biopsy if they had any of the following: (1) confirmed PSA increase more than 1.4 ng/mL above baseline in the first year of treatment (or >0.7 ng/mL in 5ARI-treated men); (2) confirmed PSA concentration greater than 4.0 ng/mL at any time (>2.0 ng/mL in 5ARI-treated men); (3) for men aged 45 to 54 years with a baseline PSA concentration less than 1.5 ng/mL, a PSA level increasing to 3.0 ng/mL at any time (<0.75 ng/mL increasing to 1.5 ng/mL for 5ARI-treated men); or (4) prostate nodule or induration at any time. For criteria 1, 2, and 3, elevations in PSA concentrations were confirmed by repeating the test.