As they age, up to 40% of men experience a decline in a hormone called testosterone. Such declines are associated with undesirable effects. Testosterone replacement therapy (TRT) has become a popular way of treating this condition, with the use of TRT increasing dramatically over the last two decades. However, the diagnosis and treatment of low testosterone levels is controversial. Moreover, there are concerns that the use of TRT might increase the risk of prostate cancer. To date, studies investigating this link have been limited and conflicting. Thus, to address this safety concern, this study will investigate whether the use of TRT is associated with an increased risk of prostate cancer using the Clinical Practice Research Datalink. The findings from this study will provide much needed information regarding TRT and prostate safety, which can help better inform on the risks and benefits of this therapy.
There is conflicting evidence regarding the association between the use of testosterone replacement therapy (TRT) and the incidence of prostate cancer. Indeed, some observational studies suggest an association, while others demonstrate safety with regards to the prostate. However, these studies had important limitations, complicating the interpretation of their findings. Given the prevalence of testosterone deficiency and the increasing use of TRT, further studies are needed to evaluate this association. Thus, this study will investigate the association between TRT and prostate cancer by assembling a cohort of 15,000 men newly-diagnosed with age-related hypogonadism between 1 January 1995 and 31 August 2016, and followed until 31 August 2017. Time-dependent Cox proportional hazards models will be used to estimate adjusted hazard ratios with 95% confidence intervals of prostate cancer associated with the use of TRT, compared with non-use. Secondary analyses will assess whether the association varies with cumulative duration of use, time since initiation, and TRT type (e.g., injection, patch, gel, pill, buccal tablet). In addition, several sensitivity analyses will be conducted to assess the robustness of the findings.
Incidence of prostate cancer in patients with age-related hypogonadism
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Corresponding Applicant - McGill University
Christel Renoux - Collaborator - McGill University
Christina Santella - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital