Contraindications of Testosterone Therapy
Testosterone therapy is absolutely contraindicated in men with breast cancer, known or suspected prostate cancer, and in women who are pregnant or may become pregnant. 1
Absolute Contraindications
- Breast cancer in men: Testosterone therapy is contraindicated in men with carcinomas of the breast 1
- Prostate cancer: Known or suspected carcinomas of the prostate represent an absolute contraindication 1, 2
- Pregnancy: Testosterone is contraindicated in women who are or may become pregnant due to risk of virilization of the female fetus 1
- Desire for fertility: TTh is contraindicated in men seeking fertility as it suppresses spermatogenesis 2
- Hypersensitivity: History of hypersensitivity to any components of testosterone preparations 1
- Male breast cancer: Active or treated male breast cancer remains an absolute contraindication for TTh due to limited safety data 2
- Age-related hypogonadism: The FDA specifically contraindicates oral testosterone formulations in men with hypogonadal conditions not associated with structural or genetic etiologies 2
Relative Contraindications and Cautions
- Severe untreated obstructive sleep apnea: Testosterone therapy may exacerbate or lead to development of sleep apnea 2
- Severe lower urinary tract symptoms: TTh should be used with caution in men with severe LUTS, though studies show it generally doesn't worsen symptoms in those with mild-moderate LUTS 2
- Polycythemia: Testosterone therapy can increase hematocrit and hemoglobin levels 1
- Congestive heart failure: Due to sodium and water retention, edema with or without congestive heart failure may be a serious complication 1
- Renal insufficiency: Testosterone should be used cautiously in patients with renal insufficiency due to fluid retention risk 2
- Hepatic dysfunction: While intramuscular and transdermal preparations don't appear to cause hepatic dysfunction, oral preparations have been associated with hepatotoxicity 2
- Acute illness: Testosterone testing and therapy should be avoided during acute illness 2
- Nitrate medication: PDE5 inhibitors (often used with testosterone for erectile dysfunction) are contraindicated with nitrates due to dangerous blood pressure decreases 2
Special Considerations for Cancer Patients
- Prostate cancer on active surveillance: Testosterone therapy should not be used in men with prostate cancer on active surveillance 2
- Prostate cancer on androgen deprivation therapy: Testosterone therapy is contraindicated in men with prostate cancer on ADT 2
- Recent cardiovascular events: Patients with recent cardiovascular events were typically excluded from testosterone trials, limiting data on safety in this population 2
Monitoring Requirements
- Prostate monitoring: Before starting therapy, patients should undergo digital rectal examination and PSA testing 2
- Follow-up evaluations: Should be performed every 3-6 months for the first year and annually thereafter 2
- PSA monitoring: Perform biopsy for PSA increase of 1.0 ng/ml in any year or if PSA rises by 0.7–0.9 ng/ml with further increase in 3–6 months 2
- Hematocrit monitoring: Regular monitoring of hematocrit is necessary to detect polycythemia 1
Emerging Evidence on Prostate Cancer
Recent evidence challenges the historical contraindication of testosterone in men with treated prostate cancer:
- The TRAVERSE trial confirmed no difference in prostate cancer incidence between testosterone and placebo groups at a mean follow-up of 33 months 2
- Limited data suggest testosterone therapy may be considered in carefully selected men who have undergone radical prostatectomy with favorable pathology and undetectable PSA 3, 4
- Studies evaluating testosterone therapy in men treated with radiation therapy suggest patients do not experience recurrence or progression of prostate cancer 3
However, despite this emerging evidence, the FDA labeling still lists prostate cancer as an absolute contraindication 1, and clinical decisions should prioritize this official guidance until more definitive evidence emerges.