Prostate Specific Antigen Levels during Testosterone Treatment of Hypogonadal Older Men: Data from a Controlled Trial

CONTEXT: Prostate-specific antigen (PSA) changes during testosterone treatment of older hypogonadal men have not been rigorously evaluated. DESIGN: Double-blinded, placebo-controlled trial. SETTING: Twelve US academic medical centers. PARTICIPANTS: Seven hundred ninety hypogonadal men >/=65 years of age with average testosterone levels /=1.7 ng/mL and 2.5% of men had an increase of >/=3.4 ng/mL. A confirmed absolute PSA >4.0 ng/mL at 12 months was observed in 1.9% of men in the testosterone group and 0.3% in the placebo group. Four men were diagnosed with prostate cancer; two were Gleason 8. CONCLUSIONS: When hypogonadal older men with normal baseline PSA are treated with testosterone, 5% had an increase in PSA >/=1.7 ng/mL, and 2.5% had an increase >/=3.4 ng/mL.