A new observational study of hypogonadal men may ease concerns over testosterone therapy, widely believed to fuel prostate cancer (PCa) despite a lack of evidence. Researchers found lower than expected incidences of PCa among the men, who received testosterone therapy for a median of 5 years (maximum 17 years).

“Testosterone therapy in hypogonadal men does not increase the risk of prostate cancer,” lead researcher Ahmad Haider, MD, PhD, of University Clinics Muenster in Germany, and colleagues stated in The Journal of Urology, published online ahead of print. “If guidelines for testosterone therapy are properly applied, testosterone treatment is safe in hypogonadal men.”

Hypogonadal men having surgery for localized prostate cancer can be “cautiously considered” candidates for testosterone  therapy after a year if there is no evidence of active disease, according to a set of guidelines the researchers described.

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For the study, the investigators examined data for a total of 1,023 men at 3 independent centers who had hypogonadism and were receiving testosterone  therapy. Hypogonadism was diagnosed when testosterone levels were 12.1 nmol/L or less and symptoms such as loss of libido and unusual weight gain were present. Patients received injections of testosterone undecanoate  in intervals of 12 weeks.

A total of 11 patients at 2 urology centers were diagnosed with PCa; the third center reported no cases. PCa incidences were 54.4 and 30.7 cases per 10,000 patients per year, respectivelylower than would be expected in the general population. The cohorts did include some younger patients, which could have affected the results.

In the interest of disclosure, several study authors noted a relationship with Bayer, which manufactures testosterone undecanoate.


  1. Haider, A et al. The Journal of Urology. 2015; doi: 10.1016/j.juro.2014.06.071