Prostate Safety Events During Testosterone Replacement Therapy in Men With Hypogonadism: A Randomized Clinical Trial

Area of Science:

• Endocrinology
• Urology
• Oncology

Background:

• The impact of testosterone replacement therapy (TRT) on prostate health remains a significant clinical question.
• Hypogonadal men often consider TRT, necessitating a clear understanding of potential prostate-related risks.

Purpose of the Study:

• To evaluate the effect of TRT compared to placebo on the incidence of high-grade prostate cancer and other adverse prostate events.
• To assess risks including any prostate cancer, acute urinary retention, and invasive prostate procedures in hypogonadal men.

Main Methods:

• A double-blind, placebo-controlled randomized clinical trial involving 5246 hypogonadal men (aged 45-80) with cardiovascular disease or risk.
• Participants received either topical 1.62% testosterone gel or placebo, with stratification for prior cardiovascular disease.
• Primary endpoint was high-grade prostate cancer incidence; secondary endpoints included any prostate cancer, urinary retention, and invasive procedures.

Main Results:

• Over 14,304 person-years, high-grade prostate cancer incidence was 0.19% with TRT vs. 0.12% with placebo (HR, 1.62; P=.51), showing no significant difference.
• Incidences of any prostate cancer, acute urinary retention, invasive procedures, and prostate biopsy were also similar between groups.
• Testosterone therapy led to a greater increase in PSA concentrations but did not significantly alter International Prostate Symptom Scores.

Conclusions:

• In carefully selected hypogonadal men, TRT did not elevate the risk of prostate cancer or other adverse prostate events.
• These findings support a more informed assessment of TRT's potential risks and benefits.
• The low incidence of prostate events in both groups underscores the importance of baseline screening.