From the FDA Drug Label
Monitor serum testosterone, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests and lipid concentrations periodically. (5.1,5.3,5.9,5.13) The recommended frequency for monitoring Prostate-Specific Antigen (PSA) levels in patients using topical testosterone therapy is periodically.
- The exact frequency is not specified in the drug label.
- It is recommended to monitor PSA levels as part of regular monitoring, but the label does not provide a specific timeframe 1.
From the Research
For men using testosterone topical therapy, PSA levels should be checked before starting treatment, then again at 3-6 months after beginning therapy, and annually thereafter if values remain stable, as supported by the most recent study 2. This monitoring schedule is particularly important for men over 40 years old. The reason for this monitoring is that testosterone therapy can potentially stimulate prostate tissue growth, which might exacerbate undiagnosed prostate cancer or benign prostatic hyperplasia. Some key points to consider:
- PSA levels should be measured before starting testosterone therapy to establish a baseline 3.
- Digital rectal examinations should be performed according to age-appropriate screening guidelines alongside PSA testing for comprehensive prostate health monitoring while on testosterone therapy 2.
- If PSA levels rise significantly (typically defined as an increase of 1.4 ng/mL or more above baseline, or a PSA velocity greater than 0.4 ng/mL per year), further evaluation by a urologist is recommended 4.
- Men with a history of prostate cancer, elevated PSA at baseline, or other prostate concerns may require more frequent monitoring as determined by their healthcare provider 5. It's essential to note that the monitoring schedule may vary depending on individual patient factors, such as age, medical history, and baseline PSA levels. The most recent study 2 highlights the importance of considering the impact of digital rectal examination on PSA measurements and clinical decision-making, which can change the clinical decision-making on a significant number of occasions. Overall, a careful and individualized approach to monitoring PSA levels in men using testosterone topical therapy is crucial to minimize the risks associated with testosterone therapy and ensure optimal prostate health.