Supplementation does not appear to affect prostate volume or PSA .
TORONTO—Six months of testosterone supplementation in older men with moderately low testosterone levels appears to be relatively safe, with little or no negative effects on the prostate, according to researchers in The Netherlands.
“We didn’t find any difference between the testosterone group and the placebo group, neither for prostate volume nor PSA nor prostate symptom score,” said investigator Yvonne van der Schouw, PhD, associate professor of epidemiology at the Utrecht University Medical Center in Utrecht.
Serum testosterone levels gradually decline with age and studies suggest that testosterone supplementation given to older men with moderately low testosterone levels might help im-prove libido, muscle mass, and other health parameters, Dr. van der Schouw said.
It is also theorized that supplementation could help improve cognitive function and possibly help com-bat diabetes and lower some risk factors for cardiovascular disease. The safety of testosterone supplementation in this group of men remains controversial, however.
Dr. van der Schouw and her colleagues conducted a double-blind, randomized, placebo-controlled trial of 237 men aged 60 to 80 years. All of the men studied had moderately low serum testosterone levels (less than 13.7 nmol/L), but were otherwise healthy. The men received either 80 mg of testosterone undecanoate twice a day for six months or a placebo. Prostate safety was assessed using rectal ultrasound, serum PSA levels, and the International Prostate Symptom Score. The investigators also looked at hematological parameters as well as kidney and liver function. A total of 207 men completed the study.
The researchers, who presented their findings here at the 89th annual meeting of The Endocrine Society, observed no significant differences between the placebo and testosterone groups in terms of prostate carcinoma, prostate volume, PSA levels, and severity of prostate symptoms. Prostate volume, however, increased significantly in the men with the lowest baseline testosterone levels, independent of baseline prostate volume or age. A study of safety parameters is ongoing.