madman
Super Moderator
ABSTRACT
Background: Physician prescribing patterns surrounding the use of testosterone therapy (TTh) in men with a history of prostate cancer (CaP) is not well described.
Aim: To characterize the demographics and usage patterns of testosterone therapy in men with a history of prostate cancer in the United States.
Methods: This was a retrospective review using Optum’s De-identified Clinformatics Data Mart database. Administrative diagnosis, procedural, pharmacy, and laboratory codes were used to identify male subjects 40 years and older with prostate cancer treated with surgery or radiation between 2003 and 2018 who went on to receive TTh. Demographic and clinical factors are identified. Temporal trends in TTh usage were reported.
Outcomes: The main outcomes were rates of testosterone prescriptions in men with treated prostate cancer and associated laboratory values such as Prostate Specific Antigen (PSA) and testosterone levels before TTh. Results: 126,374 men completed treatment for CaP during the study period (42,515 surgery, 75,186 radiation, 8,673 both). Of these, 3,074 men (2.4%) received testosterone after CaP treatment. Men who received testosterone were younger, more likely to have erectile dysfunction, depressive disorder, and lower pretreatment PSA values compared to men who did not receive it. Median PSA levels before TTh initiation were 0 − 0.2 depending on CaP treatment modality and median total testosterone level was <300 ng/dL. TTh began an average of 1.5 years after radical prostatectomy and 2.6 years after radiation treatment. We observed an increase in TTh after CaP from the beginning of the study period until it peaked in 2013 at 4.9%. After 2013, rates decreased annually until a plateau of approximately 1.8% of men. Approximately a third of men did not have testosterone labs checked before initiation of TTh.
Clinical Implications: These findings provide insight into trends in testosterone prescriptions in men after prostate cancer treatment and may aid in clinical decision-making, as well as areas for improvement in cancer survivorship care.
Strengths and Limitations: Strengths include the large sample size, length of data coverage, and real-world analysis of testosterone prescribing patterns across the United States. Limitations include the reliance on insurance claims data, the retrospective study design, and the lack of additional relevant clinical variables that may impact decision-making regarding TTh.
Conclusion: National trends in testosterone prescriptions for men with treated prostate cancer suggest that many men are treated with TTh after prostate cancer therapy with patterns of indications and monitoring consistent with the general population.
INTRODUCTION
Testosterone deficiency (TD), or hypogonadism, is defined by the combination of a low serum testosterone laboratory value and associated symptoms such as decreased libido, fatigue, depression, and lean body mass, erectile dysfunction.1 The prevalence of TD in the United States ranges from 6 to 39% depending on definitions used and populations studied.2 TD is readily treatable with testosterone therapy (TTh) and its use has increased more than six-fold between 2002 and 2013, from 0.52% of men to 3.2% in the United States.3 Despite its popularity and efficacy, 4,5 a concern surrounding the link between testosterone and prostate cancer gives some clinicians pause in prescribing TTh to patients with a history of prostate cancer (CaP). Indeed, the FDA requires labels on testosterone products warning of “the potential risk of prostate cancer and increase in prostatic specific antigen (PSA)”. 6 This may lead to some men failing to receive treatment that could otherwise benefit them.
In 1941, Drs. Huggins and Hodges established the androgen-dependent model of CaP by demonstrating regression of metastatic CaP in men who had been castrated.7 The corollary to this model led to a fear that administering testosterone to men will likewise fuel CaP growth. However, evidence has emerged in the interim that has provided a more contemporary understanding of the relationship between androgen receptor function, prostate-specific antigen (PSA) levels, and CaP growth which suggests TTh does not increase the risk of CaP recurrence. Indeed, groups have reported treating men with testosterone after the diagnosis and treatment of prostate cancer.8,9 The American Urological Association guidelines as well as numerous reviews and metaanalyses have reinforced the safety of TTh in men with TD and treated prostate cancer.10-13 Given the contradictions in product warning labels and current clinical evidence, we sought to characterize the demographics and usage patterns of TTh in men with a history of prostate cancer in the United States.
*Nevertheless, the current report demonstrates that many men are treated with TTh after prostate cancer therapy with pre-TTh PSA levels attributable to no active disease. The data on testosterone prescriptions are consistent with trends seen in the general population. TTh initiation often occurs in the presence of evidence of clinical and laboratory-confirmed TD. However, the findings that only roughly two-thirds of patients have testosterone levels checked before initiation of TTh suggests room for improvement for guideline adherent treatment of TD. Increased provider vigilance in obtaining appropriate laboratory workup in symptomatic patients before TTh is encouraged.
CONCLUSION
National trends in testosterone prescriptions for men with treated prostate cancer demonstrate that many men are treated with TTh after prostate cancer therapy. TTh is being initiated post-treatment with patterns of indications and monitoring consistent with the general population. More data are necessary and continued monitoring of testosterone prescribing trends will be important as more data become available.
Background: Physician prescribing patterns surrounding the use of testosterone therapy (TTh) in men with a history of prostate cancer (CaP) is not well described.
Aim: To characterize the demographics and usage patterns of testosterone therapy in men with a history of prostate cancer in the United States.
Methods: This was a retrospective review using Optum’s De-identified Clinformatics Data Mart database. Administrative diagnosis, procedural, pharmacy, and laboratory codes were used to identify male subjects 40 years and older with prostate cancer treated with surgery or radiation between 2003 and 2018 who went on to receive TTh. Demographic and clinical factors are identified. Temporal trends in TTh usage were reported.
Outcomes: The main outcomes were rates of testosterone prescriptions in men with treated prostate cancer and associated laboratory values such as Prostate Specific Antigen (PSA) and testosterone levels before TTh. Results: 126,374 men completed treatment for CaP during the study period (42,515 surgery, 75,186 radiation, 8,673 both). Of these, 3,074 men (2.4%) received testosterone after CaP treatment. Men who received testosterone were younger, more likely to have erectile dysfunction, depressive disorder, and lower pretreatment PSA values compared to men who did not receive it. Median PSA levels before TTh initiation were 0 − 0.2 depending on CaP treatment modality and median total testosterone level was <300 ng/dL. TTh began an average of 1.5 years after radical prostatectomy and 2.6 years after radiation treatment. We observed an increase in TTh after CaP from the beginning of the study period until it peaked in 2013 at 4.9%. After 2013, rates decreased annually until a plateau of approximately 1.8% of men. Approximately a third of men did not have testosterone labs checked before initiation of TTh.
Clinical Implications: These findings provide insight into trends in testosterone prescriptions in men after prostate cancer treatment and may aid in clinical decision-making, as well as areas for improvement in cancer survivorship care.
Strengths and Limitations: Strengths include the large sample size, length of data coverage, and real-world analysis of testosterone prescribing patterns across the United States. Limitations include the reliance on insurance claims data, the retrospective study design, and the lack of additional relevant clinical variables that may impact decision-making regarding TTh.
Conclusion: National trends in testosterone prescriptions for men with treated prostate cancer suggest that many men are treated with TTh after prostate cancer therapy with patterns of indications and monitoring consistent with the general population.
INTRODUCTION
Testosterone deficiency (TD), or hypogonadism, is defined by the combination of a low serum testosterone laboratory value and associated symptoms such as decreased libido, fatigue, depression, and lean body mass, erectile dysfunction.1 The prevalence of TD in the United States ranges from 6 to 39% depending on definitions used and populations studied.2 TD is readily treatable with testosterone therapy (TTh) and its use has increased more than six-fold between 2002 and 2013, from 0.52% of men to 3.2% in the United States.3 Despite its popularity and efficacy, 4,5 a concern surrounding the link between testosterone and prostate cancer gives some clinicians pause in prescribing TTh to patients with a history of prostate cancer (CaP). Indeed, the FDA requires labels on testosterone products warning of “the potential risk of prostate cancer and increase in prostatic specific antigen (PSA)”. 6 This may lead to some men failing to receive treatment that could otherwise benefit them.
In 1941, Drs. Huggins and Hodges established the androgen-dependent model of CaP by demonstrating regression of metastatic CaP in men who had been castrated.7 The corollary to this model led to a fear that administering testosterone to men will likewise fuel CaP growth. However, evidence has emerged in the interim that has provided a more contemporary understanding of the relationship between androgen receptor function, prostate-specific antigen (PSA) levels, and CaP growth which suggests TTh does not increase the risk of CaP recurrence. Indeed, groups have reported treating men with testosterone after the diagnosis and treatment of prostate cancer.8,9 The American Urological Association guidelines as well as numerous reviews and metaanalyses have reinforced the safety of TTh in men with TD and treated prostate cancer.10-13 Given the contradictions in product warning labels and current clinical evidence, we sought to characterize the demographics and usage patterns of TTh in men with a history of prostate cancer in the United States.
*Nevertheless, the current report demonstrates that many men are treated with TTh after prostate cancer therapy with pre-TTh PSA levels attributable to no active disease. The data on testosterone prescriptions are consistent with trends seen in the general population. TTh initiation often occurs in the presence of evidence of clinical and laboratory-confirmed TD. However, the findings that only roughly two-thirds of patients have testosterone levels checked before initiation of TTh suggests room for improvement for guideline adherent treatment of TD. Increased provider vigilance in obtaining appropriate laboratory workup in symptomatic patients before TTh is encouraged.
CONCLUSION
National trends in testosterone prescriptions for men with treated prostate cancer demonstrate that many men are treated with TTh after prostate cancer therapy. TTh is being initiated post-treatment with patterns of indications and monitoring consistent with the general population. More data are necessary and continued monitoring of testosterone prescribing trends will be important as more data become available.
