Hypogonadism is characterized by low testosterone levels that can result in symptoms such as reduced libido, erectile dysfunction (ED), fatigue, anemia, decreased bone density, decreased lean body mass, and increased body fat. 1,2 The Endocrine Society defines male hypogonadism as serum total testosterone level (T) < 300 ng/dL, a threshold at which the likelihood of most symptoms associated with hypogonadism increases. 1
Testosterone replacement therapy (TRT) is recommended for treatment of androgen deficiency in symptomatic men with unequivocally low serum T levels. Although current guidelines recommend against using TRT in men with a history of prostate cancer (PCa), 1,3 and the FDA has a black box warning against prescribing TRT for these men, little evidence suggests that TRT stimulates tumor growth in patients treated for low-risk PCa. 4-6 Retrospective studies and case series suggest that TRT can be safe in patients with low-risk PCa treated with radical prostatectomy, brachytherapy, or external beam radiation. 7,8 Despite observed increases in prostate specific antigen (PSA), TRT does not seem to increase PCa recurrence rates when used cautiously, even in men with high-risk disease. 9
Almost 3 million men living in the U.S. have been diagnosed with PCa. While 1 in 7 men will be diagnosed with PCa during their lifetime, most men diagnosed with PCa do not die of it. 10 More than 90% of patients with PCa have localized or low-grade disease that does not result in PCa-related mortality. 11 Active surveillance, brachytherapy, external beam radiation, and radical prostatectomy are considered appropriate monotherapy modalities for low-risk PCa. 12 With successful treatment of early PCa, primary care providers may increasingly encounter PCa survivors with or without symptomatic hypogonadism. Surprisingly, the prevalence of hypogonadism in men with low-risk PCa has not been reported.
The primary objective of this study was to estimate the prevalence of hypogonadism in low-risk PCa survivors who received curative treatment. A second objective was to examine the presence of hypogonadism among subgroups of patients. The authors hypothesized that the prevalence in this population may be high enough to support prospective trials designed to determine the safety of TRT in selected hypogonadal men with a history of PCa.
Methods
This is a cross-sectional study conducted at the Edward Hines, Jr. VA Hospital (EHJVA) that included a convenience sample of 52 veterans aged 25 to 100 years who had been treated for low-risk PCa more than 12 months previously and were currently receiving medical care at EHJVA. Low-risk PCa was defined as tumors with a Gleason score ≤ 6 and PSA at diagnosis < 10 or a (clinical or pathologic) American Joint Committee on Cancer (AJCC) stage I or II. Patients were excluded if they had any of the following: Gleason score > 7, PSA at diagnosis > 10, prior TRT or androgen deprivation therapy, recurrent or active PCa, incomplete treatment of PCa, or history of breast cancer. The study was approved by the institutional review board at EHJVA.
Participant Identification and Recruitment
The EHJVA cancer registry provided a roster of about 600 patients who were diagnosed with AJCC stage I or II PCa after 2002 and had completed treatment by 2011. About 50% of the patients were excluded because they no longer were receiving care at EHJVA. More than 150 patients were excluded because they did not have upcoming appointments at EHJVA, they followed up at community-based outpatient clinics, or they did not meet the remaining parameters of the inclusion criteria.
