Testosterone Replacement Therapy Does Not Increase Mortality Risk

A new analysis of Medicare data has found that prostate cancer patients who use testosterone replacement therapy live just as long as those who don't and do not have greater need for androgen deprivation therapy.

A new analysis of Medicare data has found that prostate cancer patients who use testosterone replacement therapy live just as long as those who don’t.

The paper, which appears in The Journal of Sexual Medicine, uses the records of 149,354 men who were diagnosed with prostate cancer between 1991 and 2007.

Researchers found those records amid Medicare’s Surveillance, Epidemiology, and End Results data. They then stratified subjects who had received testosterone replacement therapy by the duration of that therapy: ≤ 30 days, 31-60 days and ≥ 60 days.

After using propensity score methods to adjust for differences between groups, the researchers built a Cox proportional hazards model to evaluate the effect of testosterone replacement therapy on outcomes.

Men treated who received testosterone replacement therapy, regardless of its duration, did not experience higher overall mortality and prostate cancer-specific mortality than men who received no testosterone (all hazard ratios [HR]&thinsp;<&thinsp;1.0; all p&thinsp;≤&thinsp;0.002).

The researchers also looked to see whether men who used testosterone replacement therapy were significantly more likely to need salvage androgen deprivation therapy (ADT).

They found that men who used testosterone for up to 30 days were somewhat (but not significantly) more likely than untreated men to need salvage therapy (HR, 1.23; p=0.06) and they found the same for men who used testosterone for up to 60 days (HR, 1.05; p=0.81).

Men who used testosterone replacement therapy for longer periods, however, were significantly less likely to need salvage androgen deprivation therapy than men who never used testosterone (HR, 0.70; p=0.04).

“The use of testosterone replacement therapy (TRT) in men with prostate cancer is controversial given concerns of androgen-related cancer progression,” the study authors wrote. “Although emerging evidence suggests that TRT may be safe in this setting, no study [before this study] has investigated dose-related effects.”

Those authors went on to note several potential limitations in their work, factors such as its retrospective nature, but they also wrote that the sheer size of the study population lent considerable weight to their findings.

“TRT following prostate cancer diagnosis and treatment does not increase mortality or the use of salvage ADT,” they wrote. “Using time-varying analysis, we demonstrate that longer duration of TRT is not associated with adverse mortality or greater need for ADT.”

The findings of the new analysis lend weight to those of several other studies that have reached similar conclusions about the impact of testosterone replacement on prostate cancer, particularly in the short term.

For example, a meta-analysis of 22 randomized controlled trials appeared earlier this year in Prostate Cancer and Prostate Diseases. Results from a total of 2,351 patients were used to determine whether short-term (<12 months) or medium-term (12-36 months) of testosterone replacement were associated with any significant changes in several health marketers.

“Though for some routes of administration and some end points, the [odds ratio] associated with testosterone administration were >1, indicating increased risk, none of these reached or even approached statistical significance (all P>0.10), which was consistent with the results of subgroup analyses and sensitivity analysis,” the authors wrote.

“This meta-analysis shows that, regardless of the administration method, TRT is the short-term safety and does not promote prostate cancer development or progression,” they wrote, “but long-term data are warranted with justifiable end points.”