Jenny Pena Dias1, Denise Melvin1, Michelle Shardell1, Luigi Ferrucci1, Chee W Chia1, Mohsen Gharib1, Josephine M Egan1, Shehzad Basaria1. 1. Laboratory of Clinical Investigation (J.P.D., D.M., J.M.E.) and Translational Gerontology Branch (M.S., L.F., C.W.C.), National Institute on Aging, and Imaging Section (M.G.), Medstar Harbor Hospital, Baltimore, Maryland 21225; and Section on Men's Health, Aging, and Metabolism (S.B.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115.
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.
RCT Entities:
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.
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