Prostate Specific Antigen Levels during Testosterone Treatment
Context - Prostate specific antigen (PSA) changes during testosterone treatment of older hypogonadal men have not been rigorously evaluated. The Endocrine Society Guidelines recommendation of urological referral for a confirmed increase in PSA >1.4 ng/mL is not based on PSA changes in testosterone-treated men.
Design - Double-blinded, placebo-controlled trial.
Setting - Twelve United States academic medical centers.
Participants - 790 hypogonadal men ≥65 years with average testosterone levels ≤275 ng/dL. Men at high risk for prostate cancer were excluded.
Interventions - Testosterone or placebo gel for 12 months.
Main outcomes - Percentile changes in PSA during testosterone treatment for 12 months.
Results - Testosterone treatment that increased testosterone levels from 232 ± 63 ng/dL to mid-normal was associated with a small but significantly greater increase (p<0.001) in PSA levels than placebo treatment.
Serum PSA levels increased from 1.14±0.86 ng/mL (mean ±SD) at baseline by 0.47±1.1 ng/mL at 12 months in the testosterone group and from 1.25±0.86 ng/mL by 0.06±0.72 ng/mL in the placebo group.
Five percent of men treated with testosterone had an increase ≥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.
Cunningham GR, Ellenberg SS, Bhasin S, et al. Prostate Specific Antigen Levels during Testosterone Treatment of Hypogonadal Older Men: Data from a Controlled Trial. The Journal of Clinical Endocrinology & Metabolism 2019. 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. The Endocrine Society Guidelines recommendation of urological referral for a confirmed increase in PSA >1.4 ng/mL is not based on PSA changes in testosterone-treated men.
Design - Double-blinded, placebo-controlled trial.
Setting - Twelve United States academic medical centers.
Participants - 790 hypogonadal men ≥65 years with average testosterone levels ≤275 ng/dL. Men at high risk for prostate cancer were excluded.
Interventions - Testosterone or placebo gel for 12 months.
Main outcomes - Percentile changes in PSA during testosterone treatment for 12 months.
Results - Testosterone treatment that increased testosterone levels from 232 ± 63 ng/dL to mid-normal was associated with a small but significantly greater increase (p<0.001) in PSA levels than placebo treatment.
Serum PSA levels increased from 1.14±0.86 ng/mL (mean ±SD) at baseline by 0.47±1.1 ng/mL at 12 months in the testosterone group and from 1.25±0.86 ng/mL by 0.06±0.72 ng/mL in the placebo group.
Five percent of men treated with testosterone had an increase ≥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.
Cunningham GR, Ellenberg SS, Bhasin S, et al. Prostate Specific Antigen Levels during Testosterone Treatment of Hypogonadal Older Men: Data from a Controlled Trial. The Journal of Clinical Endocrinology & Metabolism 2019. Prostate Specific Antigen Levels during Testosterone Treatment of Hypogonadal Older Men: Data from a Controlled Trial
