MON-423 Testosterone Replacement Therapy in Patients with Prostate Cancer Treated with Androgen Deprivation Therapy: A Retrospective Database Study

Abstract G.M. Calderon: None. M.D. Aglan: None. S. Khadke: None. B.J. Connell: None. Background: In localized prostate cancer (PC), men may be treated with radiotherapy and concurrent androgen deprivation therapy (ADT) for 4-24 months. Despite cessation of ADT, testosterone levels can take years to recover and may even remain hypogonadal indefinitely in approximately 25-50% men. Testosterone replacement therapy (TRT) has been shown to improve symptoms as well as metabolic parameters in hypogonadal men. Despite decades of concern, there does not appear to be a significant increase in disease relapse in men with a history of PC treated with single modalities including surgery, external beam radiation or brachytherapy. Few series have reported on the safety and PC recurrence risk in men who have been previously treated with ADT. Aim: To investigate the risk of PC recurrence in men treated with TRT after prior ADT who did not achieve sufficient testosterone recovery post-treatment. Methodology: Using TriNetX Global Research Network, we identified patients diagnosed with PC between January, 2010 and October, 2021, who were treated with ADT and remained hypogonadal. We analyzed two cohorts: Cohort A received TRT subsequent to ADT, and Cohort B was a propensity score matched group that did not receive TRT. Individual subject data, including PC staging, TRT regimen and dose was not available. The primary endpoint was PSA rise > 2 ng/dL, used as a surrogate for PC recurrence given database limitations. Secondary endpoints were all-cause mortality (ACM) and the incidence of elevated lipids, hemoglobin A1C, and cardiovascular (CV) disorders. Results: A total of 25,413 ADT-treated PC patients were identified; 486 (2%) were given TRT and 24,927 (98%) were not. Cohort A and B were balanced after propensity score matching in terms of race, baseline metabolic and CV disorders. After TRT, Cohort A was able to achieve a testosterone > 300 ng/dL in 51.7% compared with 17.6% in Cohort B (p < 0.0001). The primary outcome of a PSA rise > 2 ng/dL was noted in 108 subjects in Cohort A (22.7%) and 106 in Cohort B (22.3%), p=0.877. There was no difference in ACM (8.4% in Cohort A vs 6.7% in Cohort B, p = 0.327). There was no observed difference between groups in terms of elevated LDL, triglycerides, total cholesterol, hemoglobin A1c, and no difference in the incidence of heart failure, ischemic heart disease, stroke, atrial fibrillation, deep vein thrombosis, and pulmonary embolism. Conclusion: Among PC patients treated with ADT and subsequent TRT, we did not observe higher rates of PSA rise. These should be interpreted with caution given the limitations of the database, however, they are in keeping with recent data suggesting TRT does not lead to increased PC recurrence after definitive treatment. The data also suggest safety in this approach without an increase in CV outcomes or ACM. Prospective data is needed in this patient population to ensure safety. Monday, June 3, 2024