Effectiveness of Subcutaneously Administered Leuprolide Acetate to Achieve Low Nadir Testosterone in Prostate Cancer Patients.

Abstract

Evidence suggests lower nadir testosterone levels during the first year of androgen deprivation therapy improve advanced prostate cancer clinical outcomes. We evaluated pivotal trials for subcutaneously administered leuprolide acetate (1-, 3-, 4-, and 6-month doses) to determine nadir testosterone levels. Pooled analysis showed 99%, 97%, and 91% of patients reached nadir testosterone ≤20, ≤10, and ≤5 ng/dL respectively (median ≤3 ng/dL). Across all available categories, $88% of patients reached nadir testosterone ≤5 ng/dL, and <3% experienced a microsurge. Achievement and maintenance of low nadir testosterone levels may improve progression-free survival and time to onset of castrate-resistant prostate cancer.