madman
Super Moderator
Prostate Specific Antigen Levels during Testosterone Treatment of Hypogonadal Older Men: Data from a Controlled Trial
Abstract
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.
Source
Abstract
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.
Source
Last edited by a moderator:
