Randomized phase 2 trial of testosterone replacement therapy in prostate cancer survivors with hypogonadism

A majority of men with prostate cancer have low-grade cancer and an excellent prognosis after radical prostatectomy. Hypogonadism and associated symptoms impair quality of life in prostate cancer survivors. Many guidelines, citing a lack of randomized clinical trials showing safety and efficacicy or testosterone replacement therapy (TRT), consider a histroy or prostate cancer a contraindication for TRT. A randomized phase 2 trial at two US centers evaluated TRT for 12 weeks in 136 low-grade prostate cancer survivors aged 40 years and older with hypogonadism, after radical prostatectomy. TRT compared to placebo significantly improved sexual activity, sexual desire, physical function, and peak aerobic performance, without biochemical recurrence during treatment and 3-month follow-up. The authors conclude that short-term TRT is safe and efficacious in improving sexual and physical function in men with low-grade prostate cancer and hypogonadism treated with radical prostatectomy; however, the trial was neither long enough nor large enough to evaluate clinical recurrence or long-term safety.