Impact of combined novel hormonal agents on testosterone levels of patients with prostate cancer undergoing treatment with leuprorelin.

Abstract

95 Background: Novel hormonal agents (NHA) are part of the management of prostate cancer (PCa) since from the high-risk localized disease throughout the disease continuum, while sustained androgen deprivation therapy (ADT), through the utilization of gonadotropin-releasing hormone (GnRH) agonists or antagonists, stands as the cornerstone of this combined treatment regimen. Although deeper and earlier PSA response rates were demonstrated with these combinations, there is a lack of information on the testosterone levels during the treatment with this doublet. In this retrospective real-world study, we meticulously analyzed data on testosterone tests obtained from a prominent Brazilian institution to comprehensively assess the clinical efficacy of leuprorelin either in monotherapy or in combinations on the management of PCa. Methods: We conducted a retrospective analysis by gathering data from the medical records of pts diagnosed with PCa who were undergoing treatment with leuprorelin alone or in combination with a novel hormonal agent (NHA). Descriptive statistics was assessed by medians and comparison between groups was assessed by chi-square test. This data collection spanned a nine-year period from 2014 to 2023. Results: A total of 1,744 tests were collected from 240 individual pts. Median baseline testosterone level was 373.9 ng/mL among those treated with leuprorelin monotherapy and 368 ng/mL for those receiving leuprorelin + NHA. Testosterone levels < 50 ng/mL were achieved in 776/786 tests (98.7%) of pts receiving leuprorelin and 945/958 tests (98.6%) in pts receiving leuprorelin + NHA (p=0.9). Testosterone levels < 20 ng/mL were found in 633/786 tests (80.5%) of pts receiving leuprorelin and 842/958 tests (87.9%) in pts receiving leuprorelin + NHA (p < 0.0001). Conclusions: In this robust institutional database analysis, we demonstrated that leuprorelin demonstrated similar levels of testosterone suppression (< 50 ng/mL) both in monotherapy or combined with NHA. However, when analyzing deeper testosterone suppression levels, the addition of NHA was associated with statistically significant difference in the rate of patients with testosterone < 20 ng/mL. These results reinforce the importance of intense hormonal treatment in pts with PCa receiving leuprorelin.