Abstract
BACKGROUND: In locoregional prostate cancer (PC), androgen deprivation therapy (ADT) is combined with radiation therapy (RT) for 4-24 months. Post-ADT, some men remain hypogonadal. Sparse data exist regarding the safety and prostate cancer recurrence risk with testosterone therapy (TTh) after prior ADT/RT. The aim of the study is to share Lahey Hospital & Medical Center's experience with patients receiving TTh after previous treatment with ADT and RT, with the goal of contributing to the existing literature on TTh safety in this population to set the stage for a prospective trial. METHODS: We abstracted clinical data in patients with stage I-IVA PC, treated with ADT and RT and subsequently received TTh between 2014-2023. The co-primary endpoints were change in prostate-specific antigen (PSA) and incidence of PC recurrence. RESULTS: Twenty-one patients met criteria. Grade groups (GG) results included: GG1, n=2; GG2, n=2; GG3, n=8; GG4, n=2; and GG5, n=7. American Joint Committee on Cancer (AJCC) stages were: I, n=2; II, n=7; III, n=7; IVA, n=5. Median interval from RT to TTh was 19 months. Prior to TTh, median testosterone was 38 ng/dL. Median follow-up was 15 months. TTh was ongoing in 15 (71.4%) patients and discontinued in 6 (28.6%). Reasons for discontinuation included testosterone recovery (n=1), hospice (not PC-related) (n=2), no perceived benefit (n=2), and physician concern for PSA rise (n=1). After TTh, median testosterone level was 318 ng/dL. Mean PSA pre- and post-TTh were 0.086 and 0.193 ng/dL (P=0.008). No patients experienced PC recurrence. One patient showed PSA bounce without recurrence. CONCLUSIONS: In men with locoregional PC who remained hypogonadal after prior ADT and RT, we found that TTh was not associated with a clinically significant rise in mean PSA and no cases of PC recurrence were documented. These findings support the case for a prospective trial in this setting.