Testosterone supplementation and the prostate: a review of the safety issue

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Purpose of review

In aging men testosterone supplementation, or replacement therapy, is rapidly increasing. Herein we review classic and recent literature regarding the main safety issue: potential adverse effects on the prostate gland.

Recent findings

The advent of transdermal testosterone administration and increasing awareness of the ‘andropause’ syndrome have led to a dramatic upsurge in testosterone replacement therapy over the past decade. Prostatic hyperplasia and carcinoma are common in men who are candidates for treatment. Known or suspected carcinoma is an absolute contraindication to testosterone replacement therapy, but much prostate disease is undiagnosed. Data from testosterone replacement therapy trials and endogenous hormone studies appear to show only a theoretical safety concern, but a recent paper from the Baltimore Longitudinal Aging Study implicates free testosterone levels as a risk factor. Screening for prostate disease by symptoms, gland palpation, and prostate specific antigen testing are recommended before starting testosterone replacement therapy and at 3, 6, and 12-month intervals thereafter.


Current data indicate that testosterone replacement therapy is being increasingly administered to aging men without apparent harm. A definitive safety trial, however, has not yet been performed. Pending that study, the responsible physician must be aware of the potential effects of testosterone on the prostate, especially as a promoter of carcinoma, and be knowledgeable about prostatic symptoms, digital rectal exam, and serum prostate specific antigen levels.

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