PSA Levels during Testosterone Treatment

Discussion in 'Men's Health Forum' started by Michael Scally MD, Jul 27, 2019.

  1. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    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
     
    Millard Baker likes this.
  2. Goingstronger

    Goingstronger Member

    Can you add comments to these studies?

    Should that increase be cause for concern?