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Verified serum PSA concentration more than 4.0 ng/mL
An increase in serum PSA concentration more than 1.4 ng/mL within any 12-month period of testosterone treatment
A PSA velocity of more than 0.4 ng/mL/year using the PSA level after 6 months of testosterone administration as the reference (only applicable if PSA data available >2 years)
Detection of a prostatic abnormality on digital rectal examination
An American Urological Association (AUA) or International Prostate Symptom Score (IPSS) prostate symptom score of more than 19