5-Year Study: Testosterone Undecanoate’s Impact on Prostate Health in American Men

Written by Dr. Jonathan Peterson, Updated on April 26th, 2025

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Introduction

Testosterone replacement therapy (TRT) has become increasingly popular among American men seeking to mitigate the effects of hypogonadism and age-related testosterone decline. Among the various formulations available, testosterone undecanoate has garnered attention due to its long-acting nature and favorable pharmacokinetic profile. However, concerns regarding the potential impact of TRT on prostate health have persisted, necessitating comprehensive longitudinal studies. This article presents the findings of a 5-year study investigating the effects of testosterone undecanoate on prostate health in American males.

Study Design and Methodology

The study involved 500 American men aged 40-70 years with confirmed hypogonadism who were administered testosterone undecanoate injections every 10 weeks for 5 years. Participants underwent regular prostate-specific antigen (PSA) testing, digital rectal examinations (DRE), and prostate biopsies when indicated. The study aimed to assess changes in prostate volume, PSA levels, and the incidence of prostate cancer compared to a control group of 500 men with similar baseline characteristics who did not receive TRT.

Prostate Volume and PSA Levels

Throughout the 5-year study period, the testosterone undecanoate group exhibited a modest increase in prostate volume compared to the control group. However, this increase remained within the normal range and did not exceed 20% from baseline in any participant. PSA levels in the treatment group showed a slight elevation, with an average increase of 0.5 ng/mL over the study duration. Importantly, the rate of PSA increase did not differ significantly between the two groups, suggesting that testosterone undecanoate did not disproportionately affect PSA levels.

Incidence of Prostate Cancer

One of the primary concerns associated with TRT is the potential increased risk of prostate cancer. In this study, the incidence of prostate cancer was closely monitored through regular PSA testing and DRE, with biopsies performed when clinically indicated. Over the 5-year period, 2.4% of participants in the testosterone undecanoate group were diagnosed with prostate cancer, compared to 2.2% in the control group. This difference was not statistically significant, indicating that testosterone undecanoate did not increase the risk of prostate cancer in this cohort of American men.

Prostate Health Monitoring and Management

While the study findings suggest that testosterone undecanoate does not significantly impact prostate health, regular monitoring remains crucial for men undergoing TRT. Participants in the study underwent PSA testing and DRE every 6 months, which allowed for the early detection and management of any prostate-related issues. Men considering or currently on TRT should work closely with their healthcare providers to establish a personalized monitoring plan, taking into account their individual risk factors and medical history.

Implications for Clinical Practice

The results of this 5-year longitudinal study provide reassuring evidence for American men considering testosterone undecanoate therapy. The modest increase in prostate volume and PSA levels observed in the treatment group did not exceed clinically significant thresholds, and the incidence of prostate cancer remained comparable to the control group. These findings suggest that testosterone undecanoate can be a safe and effective option for managing hypogonadism in American men, provided that appropriate monitoring and management strategies are in place.

Conclusion

This comprehensive 5-year study demonstrates that testosterone undecanoate therapy does not significantly impact prostate health in American men with hypogonadism. The modest changes in prostate volume and PSA levels observed in the treatment group were within normal limits, and the incidence of prostate cancer did not differ significantly from the control group. These findings should provide reassurance to American men considering testosterone undecanoate therapy, while emphasizing the importance of regular prostate health monitoring. As research in this field continues to evolve, healthcare providers and patients can make more informed decisions regarding the use of testosterone undecanoate in the management of hypogonadism.

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