Testosterone Therapy Safety Reaffirmed

Testosterone (T) therapy is routinely used in aging men with low testosterone levels. Although there is no evidence that T therapy increases the risk of prostate cancer, there are concerns and a paucity of long-term data. Ahmad Haider (Germany) and colleagues examined three parallel, prospective, ongoing, cumulative registry studies of over 1,000 men. Their analysis showed that long-term testosterone therapy in hypogonadal men is safe and does not increase the risk of prostate cancer.  A total of 1,023 patients on T therapy were followed for up to 17 years with a median follow-up of approximately 5 years. Two study cohorts of 261 (cohort 1) and 340 (cohort 2) men were treated by urologists since 2004 and a third cohort of 422 men was treated at an academic andrology center since 1996. Hypogonadism was diagnosed if testosterone was at or less than 12 nmol/L and if other symptoms were present, such as erectile dysfunction, fatigue, depression, or unfavorable changes in body composition (gaining of fat mass and waist circumference despite physical activity). If no contraindications were present, all were started on T therapy. There were six (2.3%) diagnoses of prostate cancer in cohort 1, there were five (1.5%) diagnoses of prostate cancer in cohort 2, and all biopsies were negative in cohort 3. Prostate cancer incidence per 10,000 patient-years in cohorts 1 and 2 was 54.4 and 30.7, respectively, which is lower than 116 reported by the PLCO (Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial) and 96.6 reported by the ERSPC (European Randomized Study of Screening for Prostate Cancer).  Writing that: “Testosterone therapy in hypogonadal men does not increase the risk of prostate cancer,” the study authors submit that: “ If guidelines for testosterone therapy are properly applied, testosterone treatment is safe in hypogonadal men.”