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Multidisciplinary Insights Into the Assessment, Diagnosis, and Management of Hypogonadism

Table 4. Adverse Events Associated With Testosterone Therapy1,22

Evidence of Association With Testosterone Therapy

Weak Evidence of Association With Testosterone Therapy

Erythrocytosis (wide range of risk) Acne and oily skin (infrequent) Detection of subclinical prostate cancer Reduced sperm production and fertility

Testicular atrophy or infertility (common, especially in younger men; usually reversible with cessation of treatment)

Gynecomastia Male pattern baldness (familial) Worsening of symptoms of benign prostatic hyperplasia Growth of breast cancer Induction of or worsening of obstructive sleep apnea (infrequent)

Adapted with permission.

4.0 ng/mL have biopsy-detectable prostate cancer. Prostate cancer has been diagnosed in testosterone therapy trials in men aged approximately 65 years and older.1,42,43 If raising testosterone levels into the normal range caused an increase in the risk of prostate cancer, then a higher percentage of prostate cancer would be expected in trials in which men were receiving testosterone. The same is true for the age-related incidence of prostate cancer, which begins when men are in their 40s, not their 20s, the time for peak serum levels of testosterone. In fact, the prevalence of prostate cancer increases inversely as testosterone levels decline with age. However, these studies have not been powered to detect an increase in clinical prostate cancer.

A study by Marks and colleagues of 40 men aged 44 to 78 years concluded that testosterone therapy increased serum testosterone

and DHT levels without affecting prostate tissue and expressions of several androgen dependent genes, suggesting that the risks to the prostate from testosterone therapy “may not be as great as once believed, especially if the results of the pretreatment biopsy are negative.”44 Yet, monitoring for signs of prostate cancer is mandatory during testosterone therapy1(Table 5).

An important landmark study by the Endogenous Hormones and Prostate Cancer Collaborative Group was published this year. This study compared 18 prospective longitudinal studies that analyzed whether differences in circulating levels of sex hormones were related to prostate cancer risk. This collaborative analysis definitively found no association between serum concentrations of sex hormones, including testosterone, and the risk of developing prostate cancer.45


Baseline; at 3, 6, and 12 mo; yearly thereafter

Voiding, IPSS score1,22

Baseline; prostate-related symptom assessment every 6 to 12 mo

PSA level

Baseline; at 3 and 6 mo; yearly thereafter1,22


Biopsy if abnormal baseline and if abnormal during treatment

Biopsy if PSA >4.0 ng/mL1

Biopsy if PSA increases 1.0 ng/mL or greater within any 12-mo period1

Repeat PSA measurement for PSA increase of 0.7 to 0.9 ng/mL in 1 y1

Table 5. Monitoring Prostate Health During Testosterone Therapy Parameter


DRE, digital rectal examination; IPSS, International Prostate Symptom Scale; PSA, prostate-specific antigen.

Expert snapshot estosterone and the prostate

Practitioners should counsel their patients with the following 4 points in mind:

  • 1.

    Testosterone therapy is absolutely contraindicated in men with metastatic prostate cancer

  • 2.

    There is no evidence that testosterone therapy causes prostate cancer in men

  • 3.

    There is no evidence that someone who is hypogonadal and made eugonadal has a higher risk for prostate cancer

  • 4.

    Every patient receiving testosterone therapy should be monitored for prostate-related health changes, especially men older than 50 years and men at high risk (ie, family history of prostate cancer); monitoring should begin at age 40 years for African Americans and for men who have a first-degree relative with prostate cancer

Key messages

  • Hypogonadal, symptomatic men should be treated with testosterone therapy

  • Testosterone therapy can alleviate the symptoms associated with low testosterone levels

  • The goal is a testosterone level of at least 300 to 600 ng/dL

  • Treatment should be individualized for each patient

  • The potential risks to prostate health from testosterone therapy are not be great as once believed


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