Effects of Transdermal Testosterone Gel or an Aromatase Inhibitor on Prostate Volume in Older Men

J Clin Endocrinol Metab. 2016 Apr;101(4):1865-71. doi: 10.1210/jc.2016-1111. Epub 2016 Mar 7.

Abstract

Context: T replacement is being increasingly offered to older men with age-related low T; hence, monitoring prostate health is important during T therapy. Data suggest that estrogens have an independent effect on the prostate and some effects of T on the prostate might be mediated via its aromatization to estradiol. Although some studies have assessed the effects of T replacement on prostate volume, the differential effects of T and estradiol have not been delineated.

Objective: The objective of the study was to investigate the relative effects of T and estradiol on prostate volume in older men with low T.

Participants: Thirty-one men, 65 years old or older with total T less than 350 ng/dL (measured by mass spectrometry) participated in the study.

Intervention: The intervention included randomization to 5 g transdermal T gel (TT), 1 mg oral aromatase inhibitor (AI), or placebo daily for 12 months.

Main outcome measures: The primary outcome was prostate volume measured by transrectal ultrasound at baseline and 12 months. Secondary outcomes included prostate-specific antigen levels and lower urinary tract symptoms score.

Results: Serum T levels increased in both intervention groups; estradiol levels increased in the TT group, whereas it decreased in the AI group. At 12 months, prostate volume significantly increased (4.5 ± 1.76 cc, P < .05) only in the TT group. Increase in prostate-specific antigen levels were seen in both intervention groups at 6 months (P < .01 and P < .001). The lower urinary tract symptoms score increased only in the TT group (P < .05).

Conclusions: The tropic effects of T on the prostate are mediated via its aromatization to estradiol. Administration of AI for 12 months to older men was not detrimental to the prostate.

Trial registration: ClinicalTrials.gov NCT00104572.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Cutaneous
  • Aged
  • Aged, 80 and over
  • Anastrozole
  • Aromatase Inhibitors / pharmacology*
  • Double-Blind Method
  • Humans
  • Male
  • Nitriles / pharmacology*
  • Organ Size / drug effects
  • Prostate / diagnostic imaging
  • Prostate / drug effects*
  • Testosterone / administration & dosage
  • Testosterone / pharmacology*
  • Treatment Outcome
  • Triazoles / pharmacology*
  • Ultrasonography

Substances

  • Aromatase Inhibitors
  • Nitriles
  • Triazoles
  • Anastrozole
  • Testosterone

Associated data

  • ClinicalTrials.gov/NCT00104572