HOUSTON – How does testosterone treatment of older hypogonadal men affect prostate specific antigen (PSA) changes?

That is the question raised by a study published in the Journal of Clinical Endocrinology & Metabolism. Baylor College of Medicine researchers and colleagues, including representation of the VA Puget Healthcare System in Seattle, pointed out that the effects have not been rigorously evaluated, adding that 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.1

To help answer those concerns, the study team conducted a double-blinded, placebo-controlled trial at 12 U.S. academic medical centers. Participants were 790 hypogonadal men 65 and older with average testosterone levels of less than 275 ng/dL. Men at high risk for prostate cancer were excluded.

The patients received testosterone or placebo gel for 12 months, and researchers tracked percentile changes in PSA during that treatment period.

Results indicated that testosterone treatment that increased 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. Researchers reported that 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.

In addition, the study noted that 5% 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, according to the study team, which added that four men were diagnosed with prostate cancer, with two of them Gleason 8.

“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,” the authors concluded.

  1. Cunningham GR, Ellenberg SS, Bhasin S, Matsumoto AM, et. Al. Prostate Specific Antigen Levels during Testosterone Treatment of Hypogonadal Older Men: Data from a Controlled Trial. J Clin Endocrinol Metab. 2019 Jul 23. pii: jc.2019-00806. doi: 10.1210/jc.2019-00806. [Epub ahead of print] PubMed PMID: 31504596.