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It is the opinion of this Panel that serum PSA levels should be measured prior to the commencement of testosterone therapy in patients over 40 years of age in order to minimize the risk of prescribing testosterone therapy to men with occult prostate cancer. Prior to initiating treatment, clinicians should counsel patients that, at this time, it cannot be stated definitively whether testosterone therapy increases or decreases the risk of cardiovascular events (e.g., myocardial infarction, stroke, cardiovascular-related death, all-cause mortality). In men aged 40 years and older without a history of prostate cancer, PSA levels should be evaluated prior to initiating testosterone therapy to exclude a diagnosis of prostate cancer.1 After the initial screening for PSA level, American Cancer Society guidelines should be used to monitor patients. While most studies suggest no relationship between testosterone supplementation and the incidence and progression of prostate cancer, heterogeneous findings have been reported in the literature.67 The AUA recommends that clinicians inform patients of the absence of evidence linking the use of testosterone therapy to the development of prostate cancer.1 A hematocrit of 54% or greater during testosterone therapy warrants intervention with a dose reduction and assessment of SHBG and free testosterone levels.1 This cutoff is generally consistent across treatment guidelines.39 Men with low or normal total and free testosterone and an elevated hematocrit should be referred to a hematologist (Figure 2) and possibly offered a therapeutic phlebotomy. Patients should be informed that it cannot yet be stated definitively whether testosterone therapy increases or decreases the risk of CV events (ie, myocardial infarction, stroke, CV-related death, and all-cause mortality) and that there is no definitive evidence linking testosterone therapy to a higher incidence of acute CV disease in patients with a history of CV events.1 AUA guidelines, however, recommend against starting testosterone therapy in men who have had a major adverse CV event (MACE), including myocardial infarction or stroke, within the past 3 to 6 months. It is essential to weigh the potential benefits of testosterone therapy against the tendency of exogenous testosterone to suppress HPG axis function, spermatogenesis, and fertility.37,42–44 While most healthy men will recover sperm production after discontinuing exogenous testosterone if they have normal testosterone levels, we found no definitive studies that documented the recovery of spermatogenesis in either testosterone-deficient or infertile men who have used testosterone therapy.1,45,46 Consequently, the unknown long-term impact of testosterone therapy on spermatogenesis should be discussed with patients who seek to maintain fertility.
To minimize risks, plasmatic testosterone levels should be kept within male physiological ranges (300 to 1,000 ng/dl) during hormonal treatment. However, the Testosterone Trials were designed to assess only effectiveness and not the risks of testosterone therapy, including prostate cancer or cardiovascular disease. Men receiving testosterone therapy should be monitored regularly for adverse effects and to ensure normalization of serum testosterone levels (Table 59 ). However, several meta-analyses of randomized controlled trials have not shown an increased incidence of prostate cancer.50–52 Use of testosterone therapy in men with hypogonadism and previously treated (and presumed cured) prostate cancer is controversial, with little data to guide treatment decisions in this group.53 There has long been concern that testosterone therapy may increase the risk of developing prostate cancer and increase the symptoms of benign prostatic hyperplasia.
Clinicians should monitor men receiving testosterone replacement therapy for symptom improvement, potential adverse effects, and adherence. Evidence is conflicting regarding its effect on cardiovascular events and mortality. After 1 year, prostate monitoring should conform to standard guidelines for prostate cancer screening based on the race and age of the patient.
Six patients experienced biochemical recurrence, all of whom had intermediate- or high-risk prostate cancer. Clinicians should be aware that a period of time should elapse after RT and before initiating testosterone therapy in order to allow the patient adequate time to regain functional endogenous testosterone production. There is also a dearth of data evaluating the safety of testosterone therapy in men treated with radiation therapy (RT).
Among the specific populations are younger patients and others who wish to maintain fertility, patients with a history of CV disease, those with concerns about polycythemia, those aged 65 years and older, those with obesity or type 2 diabetes, those with a high risk of prostate cancer, those with OSA, and transgender and gender-diverse patients. Treatment options currently available in the US include buccal tablets, IM injections, transdermal gels, intranasal gel, SC injections, oral capsules, and subdermal pellets (Table 3).3,4,13,15,22 Overall, most formulations of testosterone have been found to increase serum testosterone into the normal range in 75% to 97% of patients and are generally well tolerated.23–30 Each treatment option, however, has its relative advantages and disadvantages. To individualize testosterone therapy, PCPs should understand the differences among currently available testosterone therapies, including the dosing, route of administration, cost, and pharmacokinetic profiles of each, and consider these factors in the context of their patients’ health care needs and therapeutic goals. Testosterone therapy is currently available in buccal, intramuscular (IM), transdermal, intranasal, subcutaneous (SC), oral, and subdermal formulations, each of which aims to replace testosterone to approximately physiologic levels.1,3 The dramatic increase in prescriptions for testosterone therapy in some regions has been accompanied by an increase in the range of treatment options available, although not all of these are available everywhere.
Understanding the normal and ideal testosterone levels for your age is the first step towards taking charge of your health and well-being. A careful evaluation of the benefits and risks, personalized to your health status and needs, is the best approach to managing low testosterone levels in men. A healthcare provider will evaluate your symptoms, overall health, and specific testosterone levels to determine if TRT or other interventions are appropriate. Maintaining healthy testosterone levels is crucial for overall well-being and health, regardless of your age.
The few studies of testosterone therapy for depressed mood had mixed results.28–31 Testosterone therapy does not improve cognitive function in men with or without preexisting cognitive impairment.32–34 There is also mixed evidence for prescribing testosterone to improve vitality, general quality of life, and male "symptoms of aging," with some studies demonstrating improvement with therapy,35,36 and other studies finding no change.10,37 As part of the Choosing Wisely campaign, the American Urological Association says physicians should not prescribe testosterone therapy for men with erectile dysfunction and normal testosterone levels.20 In men with borderline total testosterone levels, measurement of free testosterone and sex hormone–binding globulin levels should be considered, especially in the presence of conditions that affect sex hormone–binding globulin levels (most commonly, aging, obesity, and diabetes). Male hypogonadism should be diagnosed only if there are signs or symptoms of hypogonadism and total serum testosterone levels are low on at least two occasions. Other possible risks include rising prostate-specific antigen levels, worsening lower urinary tract symptoms, polycythemia, and increased risk of venous thromboembolism.
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