TRT use was associated with a significant 16% reduction in the hazard of prostate cancer and a 13% increase in the hazard of benign prostatic hyperplasia in elderly hypogonadal men, with associations varying by treatment duration, route, and aromatase inhibitor coadministration.
Key Findings
Results
TRT use was associated with a significant 16% reduction in the hazard of prostate cancer among elderly hypogonadal men.
The prostate cancer risk analysis included 546,964 hypogonadal men following 1:1 propensity score matching.
Cox regression analysis yielded HR = 0.84 (95% CI: 0.82–0.86) for PCa hazard among TRT users.
Reductions in PCa hazard were observed across long-term (15%), short-term (16%), parenteral (12%), and topical (13%) TRT use.
Sensitivity analyses excluding individuals with elevated PSA and family history of PCa similarly demonstrated an 18% reduction in PCa hazard among TRT users.
Results
TRT use was associated with a 13% increase in the hazard of benign prostatic hyperplasia among elderly hypogonadal men.
The BPH risk analysis included 412,782 hypogonadal men following 1:1 propensity score matching.
Cox regression analysis yielded HR = 1.13 (95% CI: 1.11–1.14) for BPH hazard among TRT users.
Parenteral TRT was associated with a larger increase in BPH hazard (19%) compared to topical TRT (12%).
Long-term topical TRT use was linked to a modest 9% increase in BPH hazard.
Results
The associations between TRT and prostatic outcomes varied by treatment duration, administration route, and aromatase inhibitor coadministration.
TRT use was categorized by treatment duration (long-term vs short-term), administration route (parenteral vs topical), and aromatase inhibitor (AI) coadministration.
Parenteral TRT was associated with a larger increase in BPH hazard (19%) than topical TRT (12%).
Long-term topical TRT use showed the most modest BPH hazard increase at 9%.
Both short-term (16%) and long-term (15%) TRT use were associated with reductions in PCa hazard.
Methods
This study used a large-scale retrospective cohort design drawing from Medicare enrollment and claims data spanning 2007 to 2020.
Data were sourced from Medicare Parts A/B/C/D for men aged ≥65 with diagnosed primary or secondary hypogonadism.
Cox regression analysis and 1:1 propensity score matching, both stratified by age group, were employed.
Propensity score matching produced comparable baseline characteristics at the time of hypogonadism diagnosis between TRT users and non-users.
The PCa and BPH analyses included 546,964 and 412,782 matched hypogonadal men, respectively.
Background
Concerns about prostate-related complications frequently result in hypogonadal men remaining untreated with TRT.
The study was motivated by the clinical concern that potential prostate-related complications associated with TRT lead hypogonadal men to remain untreated.
The authors identified a need for large-scale evidence to inform clinical decision-making and support a more individualized approach to care.
Prior evidence on TRT and prostate outcomes was considered insufficient to adequately address these concerns.
Baik S, Baye F, Fung K, Xian H, McDonald C. (2026). Association Between Testosterone Replacement Therapy and Prostatic Disorders in Elderly Hypogonadal Men.. The Journal of clinical endocrinology and metabolism. https://doi.org/10.1210/clinem/dgaf504