Use Of Testosterone Replacement Therapy Research Articles

(O-13) TESTOSTERONE REPLACEMENT THERAPY AND PROSTATE CANCER PROGRESSION IN HYPOGONADAL MEN ON ACTIVE SURVEILLANCE: A RETROSPECTIVE ANALYSIS

Abstract Introduction The use of testosterone replacement therapy (TRT) in hypogonadal men with prostate cancer (PC) on active surveillance (AS) has been controversial. However, recent studies have challenged this notion, warranting further investigation. We aim to assess the impact of TRT on PC progression in hypogonadal men on AS. Methods We conducted a retrospective chart review using data from a single hospital system between 2009 and 2022. The database included hypogonadal men with PC on AS who underwent TRT. Patients with prior PC treatment were excluded. PSA and total testosterone (TT) levels were recorded at various time points, including before and after TRT initiation. One-way ANOVA was used to analyze mean PSA and TT levels, and PC treatment progression was documented. Results A total of 25 men met the inclusion criteria. Mean PSA and TT levels at each time interval showed no significant difference in PSA (P = 0.283), while TT exhibited significant variation (P = 0.0052) throughout the 2-year study period. Mean TT before TRT initiation was 311.39 ng/dL, and after TRT, it increased to 773.04 ng/dL (P = 0.00011). Only one patient (4%) underwent radiation therapy for PC five years after starting TRT. Conclusions Initiating TRT in hypogonadal men on AS for PC did not result in a significant change in PSA levels, despite an increase in testosterone. As our database expands, we aim to strengthen the study's statistical power. These findings contribute to the growing evidence supporting the potential viability of TRT in hypogonadal men on AS. Financing No conflict.

Evaluating the impact of pre-diagnostic use of statins and testosterone replacement therapy on mortality outcomes in older men with hormone-related cancers: Surveillance, Epidemiology, and End Results-Medicare 2007-2015.

The link between the pre-diagnostic use of statins and testosterone replacement therapy and their impact on hormone-related cancers, prostate cancer, colorectal cancer, and male breast cancer survival remains a topic of controversy. Further, there is a knowledge gap concerning the joint effects of statins and testosterone replacement therapy on hormone-related cancer survival outcomes. To examine the independent and joint effects of pre-diagnostic use of statins and testosterone replacement therapy on the risk of all-cause and cause-specific mortality among older men diagnosed with hormone-related cancers, including prostate cancer, colorectal cancer, and male breast cancer. In 41,707 men (≥65 years) of Surveillance, Epidemiology, and End Results-Medicare 2007-2015, we identified 31,097 prostate cancer, 10,315 colorectal cancer, and 295 male breast cancer cases. Pre-diagnostic prescription of statins and testosterone replacement therapy was ascertained and categorized into four groups (Neither users, statins alone, testosterone replacement therapy alone, and Dual users). Multivariable-adjusted Cox proportional hazards and competing-risks (Fine-Gray subdistribution hazard) models were conducted. No significant associations were found in Cox-proportional hazard models for hormone-related cancers. However, in the Fine-Gray competing risk models among high-grade hormone-related cancers, statins alone had an 11% reduced risk of hormone-related cancer-specific death (hazard ratio: 0.89; 95% confidence interval: 0.81-0.99; p 0.0451). In the prostate cancer cohort with both statistical models, the use of testosterone replacement therapy alone had a 24% lower risk of all-cause death (hazard ratio: 0.76; 95% confidence interval: 0.59-0.97; p 0.0325) and a 57% lower risk of prostate cancer-specific death (hazard ratio: 0.43; 95% confidence interval: 0.24-0.75; p 0.0029). Similar inverse associations were found among aggressive prostate cancer cases with testosterone replacement therapy alone and statins alone. No significant associations were found in the colorectal cancer and male breast cancer sub-groups. Pre-diagnostic use of statins and testosterone replacement therapy showed a survival benefit with reduced mortality in high-grade hormone-related cancer patients (only statins) and aggressive prostate cancer patients in both statistical models. Findings of testosterone replacement therapy use in aggressive prostate cancer settings could facilitate clinical trials. Further studies with extended follow-up periods are needed to substantiate these findings.

(087) Testosterone Replacement Therapy in Men on Active Surveillance for Prostate Cancer: Using a Novel Database to Examine Disease Progression

Abstract Introduction Traditionally, the use of testosterone replacement therapy (TRT) in hypogonadal men on active surveillance (AS) with prostate cancer (PC) has been controversial, and for many providers, contraindicated. However, studies suggesting a need to revisit the association between TRT and prostate cancer progression have contributed to a recent paradigm shift in this approach. More studies are needed to analyze this relationship, especially due to the psychosocial and biological consequences of testosterone deficiency. Objective We aim to examine the effects of TRT on PC progression in hypogonadal men on active surveillance. Methods In this retrospective chart review, data from men diagnosed with hypogonadism and PC at a single hospital system between 2009 to 2022 were compiled into a database. Inclusion criteria for this specific study included men who underwent TRT while being on AS protocol for PC. Men receiving prior treatment for PC such as prostatectomy or radiation therapy were excluded. For each patient, PSA and total testosterone (TT) levels were recorded at 12 and 6 months prior to TRT, at the onset of TRT, and 3, 6, and 12 months following TRT initiation. One-way ANOVA was used to analyze variance in mean PSA and TT. Mean TT levels pre-TRT and post-TRT were calculated and analyzed for a significant difference. Progression to PC treatment was noted for each patient. Results 30 men meet the study criteria. The table below demonstrates the mean PSA and TT levels at each time interval. There was a significant variation in mean TT (P=0.0031) while there was no significant difference in mean PSA levels (P=0.3003) throughout the 2-year study period. Mean TT before initiation of TRT was 297.97 ng/dL, and mean TT after TRT was 716.15 ng/dL. There was an increase in mean TT after starting TRT (P=0.00072). One patient (3.3%) eventually underwent radiation therapy for PC five years after initiating TRT. Conclusions In hypogonadal men on AS for PC, no significant change in PSA level was observed after initiating TRT, despite an increase in testosterone. As we grow the database, we aim to increase the power of this study. Our findings contribute to the mounting evidence demonstrating TRT may be a viable option for hypogonadal men on AS. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Disclosures: Consultant for AbbVie, Marius, Tolmar, Endo, Petros, Boston Scientific, Coloplast Investor: Sprout.

Use of testosterone replacement therapy to treat long-COVID-related hypogonadism.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can impair pituitary-gonadal axis and a higher prevalence of hypogonadism in post-coronavirus disease 2019 (COVID-19) patients compared with the general population has been highlighted. Here we report the first case of a patient affected with a long-COVID syndrome leading to hypogonadism and treated with testosterone replacement therapy (TRT) and its effects on clinical and quality of life (QoL) outcomes. We encountered a 62-year-old man who had been diagnosed with hypogonadotropic hypogonadism about 2 months after recovery from COVID-19 underwent a complete physical examination, general and hormonal blood tests, and self-reported questionnaires administration before and after starting TRT. Following the TRT, both serum testosterone level and hypogonadism-related symptoms were improved, but poor effects occurred on general and neuropsychiatric symptoms and QoL. Therefore, hypogonadism does not appear to be the cause of neurocognitive symptoms, but rather a part of the long-COVID syndrome; as a consequence, starting TRT can improve the hypogonadism-related symptoms without clear benefits on general clinical condition and QoL, which are probably related to the long-COVID itself. Longer follow-up might clarify whether post-COVID hypogonadism is a transient condition that can revert as the patient recovers from long-COVID syndrome. Hypogonadism is more prevalent in post-COVID-19 patients compared with the general population. In these patients, hypogonadism may be part of long-COVID syndrome, and it is still unclear whether it is a transient condition or a permanent impairment of gonadal function. Testosterone replacement therapy has positive effects on hypogonadism-related clinic without clear benefits on general symptomatology and quality of life, which are more likely related to the long-COVID itself.

Exogenous Testosterone Replacement Therapy Is Associated with Increased Risk for Vascular Graft Infections Among Hypogonadal Men

/Objective: Vascular graft infections (VGIs) are a major source of morbidity following vascular bypass surgery. Hypogonadal men may be at increased risk for impaired wound healing and infections, but it is unclear if testosterone replacement therapy (TRT) mitigates this risk. We designed this study to evaluate the relationship between hypogonadism and the use of testosterone replacement therapy (TRT) with subsequent risk for developing a VGI. We performed a retrospective analysis of claims in the MarketScan database identifying men greater than 18 years of age who underwent placement of a prosthetic graft in the peripheral arterial circulation from January 2009 to December 2020. Patients were stratified based on diagnosis of hypogonadism and use of TRT within 180-days prior to surgery. The primary outcome was VGI and the need for surgical excision. The association between hypogonadism and TRT use on risk of VGI was analyzed using Kaplan-Meier plots and multivariate Cox proportional hazards models. We identified 18,312 men who underwent a prosthetic bypass graft procedure in the upper and lower extremity during the study period, of which 802 (5%) had diagnosis of hypogonadism. Among men with hypogonadism, 251 (31%) were receiving TRT. Patients on TRT were younger, more likely to be diabetic, and more likely develop a VGI during follow-up (14% vs. 8%; P<.001) that was in the lower extremity. At 5-years, freedom from VGI was significantly lower for hypogonadal men on TRT than patients not on TRT or without hypogonadism (Log rank P<.001). In Cox regression models adjusted for age, diabetes, obesity, smoking, corticosteroid use, and procedure type, hypogonadal men on TRT were at a significantly increased risk of graft infection (HR:1.94, 95%CI:1.4-2.7; P<.001) compared to controls. This study demonstrates TRT among hypogonadal men is associated with an increased risk of prosthetic VGIs. Temporary cessation of TRT should be considered for men undergoing prosthetic graft implants, particularly those in the lower extremity.

Testosterone Replacement Therapy in Relation With Cardiovascular Disease in Cisgender Women and Transgender People.

This study aimed to investigate the association of testosterone replacement therapy (TTh) with risk of cardiovascular disease (CVD), and CVD-specific outcomes, in cisgender women and transgender population, and to determine whether this association varies by menopausal status. In 25 796 cisgender women and 1580 transgender people (≥30 years old) who were enrolled in the Optum's deidentified Clinformatics Data Mart Database (2007-2021), we identified 6288 pre- and postmenopausal cisgender women and 262 transgender people diagnosed with incident composite of CVD (coronary artery disease [CAD], congestive heart failure, stroke, and myocardial infarction). Prediagnostic prescription of TTh was ascertained for this analysis. Multivariable adjusted Cox proportional hazards models were used to examine the independent association of TTh with incident CVD. We found a 24% increased risk of CVD (hazard ratio [HR] = 1.24; 95% CI, 1.15-1.34), 26% risk of CAD (HR = 1.26; 95% CI, 1.14-1.39), and a 29% risk of stroke (HR = 1.29; 95% CI, 1.14-1.45) after comparing cisgender women who used TTh with nonusers. Stratification by age group showed similar effects of TTh on CVD, CAD, and stroke. Among transgender people, TTh did not increase the risk of composite CVD, including by age stratification. Use of TTh increased the risk of CVD, CAD, and stroke among cisgender women but not among transgender people. TTh is becoming more widely accepted in women, and it is the main medical treatment for transgender males. Therefore, use of TTh should be further investigated for the prevention of CVD.

(063) Association between Comorbidities and Longitudinal Changes in Total Testosterone among men from the Baltimore Longitudinal Study of Aging

Abstract Introduction Previous cross-sectional and longitudinal studies have described decreasing testosterone levels with age in men. However, the longitudinal impact of acquired comorbidities in aging males on the relationship between age and testosterone has not been thoroughly investigated. Objective In this longitudinal study, we aimed to evaluate the longitudinal association between age and testosterone levels and to investigate the impact of additive comorbidity burden on this relationship. We hypothesized that when controlling for the presence of comorbidities commonly acquired with age, there would be no association between age and serum total testosterone level. Methods Participants were selected from the Baltimore Longitudinal Study of Aging. Data was obtained on presence of several comorbidities and total testosterone level during each follow-up visit. All men with diagnosis of prostate cancer or documented use of testosterone replacement therapy during their follow-up period were excluded from analysis. A stepwise regression analysis was performed, including a final multivariate panel regression model in order to determine the impact of age on testosterone level while controlling for individual comorbidities. Results A total of 1,784 men were included in this study, with a mean age of 71 years and overall mean testosterone level of 463.2 ng/dL. Participants had an average of 3.23 comorbidities. On multivariable-adjusted panel regression analysis, age was not significantly associated with testosterone decline, while anemia, diabetes mellitus, heart failure, obesity, peripheral artery disease, and stroke were inversely associated with total testosterone level. We report no association between cancer and total testosterone. Conclusions In this large longitudinal study, we found that when adjusted for the presence of concomitant comorbidities, age does not predict a significant decline in testosterone level with age. With the overall increase in life expectancy, and the simultaneous rise in the incidence of comorbidities such as diabetes and dyslipidemia, our findings may help optimize screening and treatment for late-onset hypogonadism in patients with multiple comorbidities. Disclosure No

Use of weight loss medications in relation with prostate, colorectal and male breast cancers among older men: SEER-Medicare 2007-2015.

The association of weight loss medications with prostate (PCa), colorectal (CRC) or male breast cancers, including assessment of these cancers combined (HRCs, hormone-associated cancers) remain poorly understood. Testosterone replacement therapy (TTh) is reported to be inversely associated with obesity, PCa and CRC, but it is unclear whether TTh modifies the association of weight loss medications with HRCs. In 49,038 men (≥ 65years) of SEER-Medicare, we identified 15,471 men diagnosed with PCa, 4836 with CRC, and 141 with male breast cancers. Pre-diagnostic prescription of weight loss medications and TTh was ascertained for this analysis. Weighted multivariable-adjusted conditional logistic and Cox proportional hazards (mortality) models were conducted. We found an inverse association between use of weight loss medications and incident PCa (OR 0.59, 95% CI 0.57-0.62), CRC (OR 0.86, 95% CI 0.80-0.92), and HRCs (OR 0.65, 95% CI 0.62-0.68). Similar associations were observed for advanced stage at diagnosis of PCa and CRC. Effects of weight loss medications on PCa and HRC remained significant irrespective of the use of TTh but were only suggestive with CRC with positive TTh use. No associations were observed with male breast cancer and HRCs mortality. Pre-diagnostic use of weight loss medications reduced the incidence of PCa, CRC, and HRCs. These associations persisted in the same direction irrespective of the history of TTh use. Future studies are needed to confirm these findings and to identify underlying biological mechanisms of weight loss medications and TTh on the risk of cancer.

Profile and Role of Serum Hypothalamic-Pituitary-Testicular-Axis Hormones on Sexual Function of Older Men with Type-2 Diabetes

Little information is available on the complex endocrinology of sexual dysfunction, which is frequently associated with ageing and diabetes. We wanted to examine the serum profile of hypothalamic-pituitary-testicular-axis (HPTA) hormones and how they relate to sexual function in older men with type-2 diabetes. This study included 74 participants (44 type-2 diabetics and 30 healthy controls). The enzyme-linked immunosorbent assay (ELISA) method was used to measure serum levels of total testosterone (Te), follicle-stimulating hormone (FSH), luteinizing hormone (LH), and prolactin (PRL). Compared to controls, diabetic patients had significantly higher FSH and PRL levels but lower Te levels. Testosterone was found to be significantly correlated with sexual intercourse frequency (p&lt;0.01), erectile function, and libido (p&lt; 0.001). We discovered significant (p &lt; 0.001) relationships between libido, penile erection, and FSH, as well as between PRL and libido (p&lt; 0.05). When compared to the other hormones, testosterone had the strongest associations with the frequency of sexual intercourse (p&lt; 0.05), libido (p&lt; 0.05), and penile erection (p&lt; 0.01). Our findings indicated that HPTA hormones might have a significant influence on sexual functions in type-2 diabetic patients, with Te being the most important HPTA hormone influencing sexual functions in diabetic patients. This study, therefore, helps to clarify the complex endocrinology and physiology of the sexual dysfunction frequently observed in older men with type-2 diabetes and also supports the use of testosterone replacement therapy in older diabetic adults.

Use of testosterone replacement therapy in the rehabilitation of patients with intensive care unit-associated weakness and hospital-associated deconditioning: the Singapore General Hospital rehabilitation experience.

Rehabilitation medicine in a tertiary care hospital involves attending to many patients affected by intensive care unit (ICU)-associated weakness (ICU-AW) and hospital-associated deconditioning (HAD). These conditions contribute to poor long-term functional outcomes and increased mortality. We explored the role of short-term adjunctive androgen therapy in this group of patients in improving the rehabilitative outcomes. This was a retrospective analysis of five patients with either ICU-AW or HAD who were given testosterone replacement therapy (TRT) or oxandrolone for a total of 2 weeks during the period from April to November 2020 was undertaken. During the 2-week trial period, the subjects underwent standard rehabilitation therapy. Grip strength was used as the primary outcome measure, and the mean improvement was 4.2 kg (+24.9%), which is encouraging in a 2-week timeframe. This was matched with good functional recovery in terms of distance ambulated and less assistance needed for ambulation. Sex hormone analysis was also done before initiation of TRT, and it showed that four out of five of the subjects were biochemically hypogonadal. None of the subjects dropped out or experienced any significant adverse events over the 2-week trial period. All the subjects except one improved to full independence at 3 months post-discharge. TRT has the potential to be used as a useful adjunct to standard rehabilitation in enhancing functional recovery in critically ill patients. A multidisciplinary approach would ensure that suitable patients benefit from optimal nutrition, optimal rehabilitation and synergistic testosterone therapy in a clinically sound and resource-efficient fashion.

Androgens and Hepatic Adenomas: A Review from a Urological Perspective

In the 21st century, there has been a significant increase in the use of testosterone replacement therapy (TRT) for men with symptoms of hypogonadism and a desire for more energy, muscle mass, etc. The TRT guidelines as defined by the American Urological Association have made all urologists familiar with the associated risks of polycythemia or infertility. However, there is a longer history and more persistent use of androgenic anabolic steroids (AAS) in men who are body building and trying to improve muscle mass. The goal of this mini review is to share and educate physicians on the additional risks of hepatic masses with the use of AAS and their pathophysiology.

124-LB: Incidence and Risk Factors of Erythrocytosis following Initiation of Sodium–Glucose Cotransporter 2 Inhibitors in Men with Type 2 Diabetes in Real-World Setting

Background: Analyses of prospective trials consistently demonstrated that therapy with sodium-glucose cotransporter-2 inhibitors (SGLT-2i) in type 2 diabetes (T2D) results in mild but significant increase in hematocrit (Hct) . We sought to determine if SGLT-2i therapy poses risk of erythrocytosis (ERY) in routine clinical practice. Methods: This was a retrospective study of T2D US Veterans who were prescribed an SGLT-2i and had adequate adherence based on the proportion of days covered &amp;gt;80% during 3/2013-12/2019 and baseline Hct&amp;lt;50%. ERY incidence was defined as first Hct&amp;gt;54% within 180 days of an SGLT-2i initiation. The detailed patient data were obtained using the VA Informatics and Computing Infrastructure (VINCI) database. Odds ratio (OR) of ERY risk was calculated by logistic regression models adjusted for case-mix. Results: We identified 9402 patients (76.0% Whites/14.7% Blacks) with baseline mean±SD age 65.0±8.9 yrs, BMI 34.1±6.3 kg/m2, Hct 41.5±4.1 % and hemoglobin A1c 8.5±1.2 %. By the end of observation period, mean Hct increased from the baseline by 1.74% [95% CI 1.68-1.80] in the entire cohort and 61 patients (0.65% of the cohort) developed ERY. We found that BMI, tobacco use, or obstructive sleep apnea (OSA) were not associated with risk of developing ERY. However, concomitant use of testosterone replacement therapy (TRT) was associated with significant ERY risk compared with SGLT-2i users not on TRT in both unadjusted analyses (OR 12.28 [95% CI 5.29-25.10]) and after adjustments for age, race, BMI, OSA, and tobacco use (OR 7.26 [95% CI 2.95-16.04]) . The risk of ERY was independent of baseline Hct or modality of TRT (topical vs. injectable) . Conclusions: For the first time, we demonstrated that SGLT-2i initiation in men with T2D in real world clinical setting can result in detectable risk of erythrocytosis. It appears that concomitant TRT can significantly influence that risk. We recommend monitoring for Hct changes following SGLT-2i initiation and, particularly, in those persons who receive testosterone therapy. Disclosure A. R. Gosmanov: Research Support; AbbVie Inc., Kowa Research Institute, Inc., Speaker’s Bureau; AstraZeneca. D. E. Gemoets: None. M. A. Green: None. K. Schumacher: None.

Joint association of statins and testosterone replacement therapy with cardiovascular disease among older men with prostate cancer: SEER-Medicare 2007–2015

BackgroundUse of statins and testosterone replacement therapy (TTh) have been independently linked with prostate cancer (PCa) and cardiovascular diseases (CVD).However, there is a research gap about the joint association of statins and TTh with CVD among PCa survivors and a matched cancer-free cohort. MethodsIn SEER-Medicare 2007–2015 (N = 35,990 men), we identified 17,995 PCa survivors, and 17,995 age- and index-matched cancer-free men. Pre-diagnostic prescription of statins and TTh was ascertained for this analysis and examined in two matched cohorts. Weighted multivariable-adjusted conditional logistic regression models were used to evaluate the independent and joint associations of statins and TTh with CVD. ResultsWe found that independently statins (OR = 0.48, 95% CI: 0.44–0.53) and TTh (OR = 0.74, 95% CI: 0.0.61–0.90) were each inversely associated with CVD in the overall sample. TTh plus statins was inversely associated with CVD (OR = 0.50, 95% CI: 0.36–0.70, Pinteraction = 0.03). Similar associations were observed among the matched cancer-free cohort. Among PCa survivors, only statins (OR = 0.62, 95% CI: 0.56–0.68) and combination of TTh plus statins (OR = 0.63, 95% CI: 0.44–0.90) were inversely associated with CVD, but not the independent use of TTh. ConclusionPre-diagnostic use of statins and TTh, independent or in combination, were inversely associated with CVD in the overall and cancer-free populations, but among PCa survivors it was mainly use of statins, not TTh. Greater reduced effects on CVD were observed with statins or in combination with statins, but not with TTh. Future studies need to confirm these associations among older men with aggressive PCa.

Understanding and managing the suppression of spermatogenesis caused by testosterone replacement therapy (TRT) and anabolic-androgenic steroids (AAS).

Use of testosterone replacement therapy (TRT) and anabolic–androgenic steroids (AAS) has increased over the last 20 years, coinciding with an increase in men presenting with infertility and hypogonadism. Both agents have a detrimental effect on spermatogenesis and pose a clinical challenge in the setting of hypogonadism and infertility. Adding to this challenge is the paucity of data describing recovery of spermatogenesis on stopping such agents. The unwanted systemic side effects of these agents have driven the development of novel agents such as selective androgen receptor modulators (SARMs). Data showing natural recovery of spermatogenesis following cessation of TRT are limited to observational studies. Largely, these have shown spontaneous recovery of spermatogenesis after cessation. Contemporary literature suggests the time frame for this recovery is highly variable and dependent on several factors including baseline testicular function, duration of drug use and age at cessation. In some men, drug cessation alone may not achieve spontaneous recovery, necessitating hormonal stimulation with selective oestrogen receptor modulators (SERMs)/gonadotropin therapy or even the need for assisted reproductive techniques. However, there are limited prospective randomized data on the role of hormonal stimulation in this clinical setting. The use of hormonal stimulation with agents such as gonadotropins, SERMs, aromatase inhibitors and assisted reproductive techniques should form part of the counselling process in this cohort of hypogonadal infertile men. Moreover, counselling men regarding the detrimental effects of TRT/AAS on fertility is very important, as is the need for robust randomized studies assessing the long-term effects of novel agents such as SARMs and the true efficacy of gonadotropins in promoting recovery of spermatogenesis.

Changes in anthropometric characteristics, androgen and estrogen levels during correction of male hypogonadism with testosterone or hCG: results of a retrospective comparative study

Background: The use of testosterone replacement therapy (TRT) is widespread. Despite the positive changes, such as: an increase in testosterone levels, an improvement in erectile function and an increase in libido, it is possible to develop a negative manifestation — hyperestrogenism. To date, there are no studies assessing the prevalence of hyperestrogenism in the presence of TRT.Aim: To study the reliability of an increase in total testosterone and estradiol levels and changes in total weight, body mass index (BMI), waist circumference (WC) and hips (OB), depending on the type of TRT and hCG therapy.Materials and methods: For retrospective analysis, the medical records of patients with baseline testosterone deficiency and normal estradiol levels, who were prescribed TRT or hCG therapy, were selected. The patients were divided into 3 groups depending on the form of TRT and hCG therapy. The level of testosterone, estradiol, sex hormone binding globulin (SHBG), weight, OT, OB, BMI in each group was assessed 2 times — before the appointment of treatment and at different periods of treatment, for example, after 3–6–9 and 12 months. Most of the patients had a period of monitoring these parameters before the appointment of TRT or hCG therapy and after 6 months.Results: The increase in the levels of total testosterone and estradiol against the background of TRT in the total sample was 109.6% and 111.3%, respectively. In each group, increases in total testosterone and estradiol levels were significant, p ≤ 0.001. The level of total testosterone to physiological values increased only in the 2-nd group — reaching the average-normal, recommended levels, from 8.7 ± 0.5 (2.5) to 16 ± 2 (10). The maximum rises in total testosterone, as well as estradiol, were noted in the 1st group, from 9.5 ± 0.72 nmol / L (3) to 24.9 ± 2.7 nmol / L (11.62)) and with 24.19 ± 2 (8.5) to 58.1 ± 4 (18.1), respectively. TRT, like hCG therapy, promotes an increase in the level of estradiol, which was demonstrated in all groups, and not only in group 1-st: in group 2-nd from 28.1 ± 2.3 (11.3) to 55 ± 4 (20) and in the 3-rd group from 27.1 ± 2.5 (10.5) to 55.8 ± 4.6 (19.6). On average for the entire sample, from 26.6 ± 1.32 (10.2) to 56.2 ± 2.5 (19). Weight loss on TRT was significant only in the 2-nd group, and in all parameters — weight, BMI, waist and hip circumference. In the 3-rd group, BMI, WC and OB values also slightly decreased. In the 1-st group, the total weight slightly increased, while the BMI did not change, as did the OB value, and the OT value decreased slightly.Conclusion: TRT significantly increases the levels of total testosterone and estradiol, contributing to the normalization of testosterone levels, as in the 2-nd group, or the development of supraphysiological levels of total testosterone and hyperestrogenism, as in the 1st and 3-rd groups. Given that there is a strong belief that TRT leads to significant weight loss, our study confirmed this statement only in the 2-nd group.

Изменения антропометрических характеристик, уровня андрогенов и эстрогенов при коррекции мужского гипогонадизма препаратами тестостерона или хорионического гонадотропина: результаты ретроспективного сравнительного исследования

Background: The use of testosterone replacement therapy (TRT) is widespread. Despite the positive changes, such as: an increase in testosterone levels, an improvement in erectile function and an increase in libido, it is possible to develop a negative manifestation — hyperestrogenism. To date, there are no studies assessing the prevalence of hyperestrogenism in the presence of TRT. Aim: To study the reliability of an increase in total testosterone and estradiol levels and changes in total weight, body mass index (BMI), waist circumference (WC) and hips (OB), depending on the type of TRT and hCG therapy. Materials and methods: For retrospective analysis, the medical records of patients with baseline testosterone deficiency and normal estradiol levels, who were prescribed TRT or hCG therapy, were selected. The patients were divided into 3 groups depending on the form of TRT and hCG therapy. The level of testosterone, estradiol, sex hormone binding globulin (SHBG), weight, OT, OB, BMI in each group was assessed 2 times — before the appointment of treatment and at different periods of treatment, for example, after 3–6–9 and 12 months. Most of the patients had a period of monitoring these parameters before the appointment of TRT or hCG therapy and after 6 months. Results: The increase in the levels of total testosterone and estradiol against the background of TRT in the total sample was 109.6% and 111.3%, respectively. In each group, increases in total testosterone and estradiol levels were significant, p ≤ 0.001. The level of total testosterone to physiological values increased only in the 2-nd group — reaching the average-normal, recommended levels, from 8.7 ± 0.5 (2.5) to 16 ± 2 (10). The maximum rises in total testosterone, as well as estradiol, were noted in the 1st group, from 9.5 ± 0.72 nmol / L (3) to 24.9 ± 2.7 nmol / L (11.62)) and with 24.19 ± 2 (8.5) to 58.1 ± 4 (18.1), respectively. TRT, like hCG therapy, promotes an increase in the level of estradiol, which was demonstrated in all groups, and not only in group 1-st: in group 2-nd from 28.1 ± 2.3 (11.3) to 55 ± 4 (20) and in the 3-rd group from 27.1 ± 2.5 (10.5) to 55.8 ± 4.6 (19.6). On average for the entire sample, from 26.6 ± 1.32 (10.2) to 56.2 ± 2.5 (19). Weight loss on TRT was significant only in the 2-nd group, and in all parameters — weight, BMI, waist and hip circumference. In the 3-rd group, BMI, WC and OB values also slightly decreased. In the 1-st group, the total weight slightly increased, while the BMI did not change, as did the OB value, and the OT value decreased slightly. Conclusion: TRT significantly increases the levels of total testosterone and estradiol, contributing to the normalization of testosterone levels, as in the 2-nd group, or the development of supraphysiological levels of total testosterone and hyperestrogenism, as in the 1st and 3-rd groups. Given that there is a strong belief that TRT leads to significant weight loss, our study confirmed this statement only in the 2-nd group.

The role of testosterone replacement therapy and statin use, and their combination, in prostate cancer

Previous studies have reported conflicting results in the associations of testosterone replacement therapy (TTh) and statins use with prostate cancer (PCa). However, the combination of these treatments with PCa stage and grade at diagnosis and prostate cancer-specific mortality (PCSM) and by race/ethnicity remains unclear.We identified non-Hispanic White (NHW, N = 58,576), non-Hispanic Black (NHB, n = 9,703) and Hispanic (n = 4,898) men diagnosed with PCa in SEER-Medicare data 2007-2011. Pre-diagnostic prescription of TTh and statins was ascertained for this analysis. Multivariable-adjusted logistic and Cox proportional hazards models were used to evaluate the association of TTh and statins use with PCa stage and grade and PCSM.22.5% used statins alone, 1.2% used TTh alone, and 0.8% used both. TTh and statins were independently, inversely associated with PCa advanced stage and high grade. TTh plus statins was associated with 44% lower odds of advanced stage PCa (OR 0.56, 95% CI 0.35-0.91). As expected, similar inverse associations were present in NHWs as the overall cohort is mostly comprised NHW men. In Hispanic men, statin use with or without TTh was inversely associated with aggressive PCa.Pre-diagnostic use of TTh or statins, independent or in combination, was inversely associated with aggressive PCa, including in NHW and Hispanics men, but was not with PCSM. The findings for use of statins with aggressive PCa are consistent with cohort studies. Future prospective studies are needed to explore the independent inverse association of TTh and the combined inverse association of TTh plus statins on fatal PCa.

MP45-14 IMPACT OF A NEW ORAL TESTOSTERONE UNDECANOATE ON BLOOD PRESSURE AND CARDIOVASCULAR RISK

INTRODUCTION AND OBJECTIVE:Chronic use of testosterone replacement therapy (TRT) might impact cardiovascular (CV) risk. Clinical trials for recently approved TRTs have shown impacts on blood pressu...

Testosterone Replacement Therapy and the Risk of Prostate Cancer in Men With Late-Onset Hypogonadism.

The association between the use of testosterone replacement therapy (TRT) and prostate cancer remains uncertain. Thus, we investigated whether TRT is associated with an increased risk of prostate cancer in men with late-onset hypogonadism. We used the UK Clinical Practice Research Datalink to assemble a cohort of 12,779 men who were newly diagnosed with hypogonadism between January 1, 1995, and August 31, 2016, with follow-up until August 31, 2017. Exposure to TRT was treated as a time-varying variable and lagged by 1 year to account for cancer latency, with nonuse as the reference category. During 58,224 person-years of follow-up, a total of 215 patients were newly diagnosed with prostate cancer, generating an incidence rate of 3.7 per 1,000 person-years. In time-dependent Cox proportional hazards models, use of TRT was not associated with an overall increased risk of prostate cancer (hazard ratio = 0.97; 95% confidence interval: 0.71, 1.32) compared with nonuse. Results remained consistent in secondary and sensitivity analyses, as well as in a propensity score-matched cohort analysis that further assessed the impact of residual confounding. Overall, the use of TRT was not associated with an increased risk of prostate cancer in men with late-onset hypogonadism.

Is there a role for testosterone replacement therapy in reducing biochemical recurrence following radical prostatectomy?

5085 Background: Historically, the use of testosterone replacement therapy (TRT) has not been recommended in men with a history of prostate cancer (PC). However, low testosterone levels are significantly associated with metabolic complications, decreased sexual function, and (more recently) high-grade PC. In 2009, in hopes of improving sexual function outcomes in men following radical prostatectomy (RP), we began treating low-risk patients with TRT. The current study examines the impact of TRT on biochemical recurrence (BCR). Methods: Between December 2009 and June 2018, a cohort of 850 patients underwent RP by a single surgeon. 152 (18%) men were postoperatively placed on TRT for recovery of sexual function. All data was prospectively collected and retrospectively analyzed. TRT patients were proportionately matched to 419 control patients by pathologic Gleason Grade Group (GGG) and stage. Univariate and multivariate comparisons were used to compare rates and time to BCR (two consecutive PSAs ≥ 0.2 ng/dl); Cox regression modeling was used to generate a survival function at the mean of covariates. Results: There were no statistically significant differences in preoperative PSA, age, prostate weight, pathologic GGG and stage between the control versus TRT groups. Median follow-up time was 3 years in both groups. 7/152 (4.6%) and 39/419 (9.3%) patients experienced BCR in the TRT versus control groups, respectively (unadjusted, p=0.068). In adjusted time to-analysis, TRT was an independent predictor of recurrence-free survival, after controlling for GGG, p-stage, preoperative FT and PSA. A patient on TRT was approximately 53% less likely to experience a BCR (OR: 0.534, 95%CI: 0.288-0.993). Conclusions: After accounting for pathologic GGG, stage, and other significant covariates, the use of TRT independently reduced recurrence post-RP. These results suggest the need for a multi-center randomized control trial.