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Clinical Practice

Blue November and the Role of Testosterone Replacement Therapy in Men's Health

6 min read
Dr. Francisco Tostes

Dr. Francisco Tostes

Scientific Director, SottoPelle Brasil

Blue November and the Role of Testosterone Replacement Therapy in Men's Health

During Blue November, we explore recent evidence on the safety of Testosterone Replacement Therapy and its relationship with prostate cancer.

Blue November is a worldwide awareness campaign focused on the importance of early diagnosis of prostate cancer. During the month of November, the campaign encourages men to take care of their health and undergo essential preventive examinations.

Prostate cancer is the second most common type of cancer among men, behind only skin cancer. In Brazil, every 38 minutes a man loses his life due to this disease. Despite this, there is still great controversy about whether Testosterone Replacement Therapy (TRT) may or may not increase the risk of prostate cancer. However, several studies already suggest that this relationship is unlikely.

Recent Scientific Evidence on TRT and Prostate Cancer

Recently, research published in the prestigious JAMA examined in depth the effects of TRT in relation to prostate cancer and other prostatic events. The study, entitled "Prostate Safety Events During Testosterone Replacement Therapy in Men With Hypogonadism", was a randomized, double-blind clinical trial with 5,246 participants.

Study Methodology

The study compared the effects of TRT with placebo in men between 45 and 80 years old, all with low testosterone levels (below 300 ng/dL). Men with elevated PSA levels (>3.0 ng/mL) or severe urinary symptoms were excluded.

Main Conclusions of the Study on Testosterone and Prostatic Health

Prostate Cancer Risk

There was no significant difference in the incidence of prostate cancer between the TRT and placebo groups, indicating that hormone therapy with testosterone does not increase the risk of high-grade cancer.

Secondary Events and Urinary Symptoms

The incidence of:

  • Acute urinary retention
  • Procedures for benign prostatic hyperplasia (BPH)
  • Treatments for urinary symptoms

Also did not differ significantly between groups. PSA levels increased slightly in the TRT group but stabilized after 12 months, without relevant progression of urinary symptoms.

Monitoring and Safety

This is one of the largest randomized studies on TRT and prostate cancer to date. The evidence is robust and supports that hormone therapy does not increase the risk of serious prostate-related events in men carefully selected for treatment.

Study Limitations

Despite the positive evidence, the study has limitations:

  • Exclusion of risk groups: Individuals with a history of prostate cancer and elevated PSA levels were excluded
  • Follow-up time: The 33-month follow-up, although extensive, may still not be sufficient to fully evaluate the long-term effects of TRT
  • Discontinuation rate: High in both TRT and placebo groups, mainly due to the COVID-19 pandemic

Final Considerations on Hormone Therapy and Blue November

This study strengthens the safety of Testosterone Replacement Therapy in men with hypogonadism, providing additional support for physicians and patients to make more informed decisions about treatment.

Although TRT does not appear to increase the risk of prostate cancer, careful patient selection and continuous monitoring are essential to ensure the safety and efficacy of testosterone hormone treatment.

During Blue November, in addition to the focus on early diagnosis, awareness about treatments such as TRT and their impact on men's health is fundamental to promoting a more comprehensive and safe approach to men's health.


Article written by the Scientific Director of SottoPelle Brasil, Dr. Francisco Tostes.

blue novembertestosteroneprostate cancerTRTmen's healthhypogonadismprevention