(131) INCIDENCE OF ADVERSE UROLOGICAL EVENTS AND ALL-CAUSE MORTALITY IN MEN WITH FUNCTIONAL HYPOGONADISM IN A 16-YEAR REAL-WORLD EVIDENCE REGISTRY STUDY

Abstract Introduction Despite accumulating contrary evidence, adverse urological events of testosterone therapy (TTh) in men with functional hypogonadism remain a concern for many physicians and need to be monitored during TTh. Objective To assess incident adverse urological events in men with functional hypogonadism receiving TTh in comparison to an untreated control group. Methods In a long-term registry study in men with hypogonadism (defined by total testosterone ≤350 ng/mL and at least moderate symptoms assessed by the Aging Males’ Symptoms scale, AMS) in a single urology office, 824 men had functional hypogonadism. 409 men received testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group), 415 opted against TTh and served as controls (CTRL). Means and standard deviations of absolute measures over 16 years of treatment and changes over time between groups, compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, WC, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the two groups are reported. Results Baseline age was 57.7 ± 7.0 years in the T-group and 62.7 ± 5.3 years in CTRL (p < 0.0001). Mean (median) follow-up was 11.9 ± 3.7 (12) years in the T-group and 11.9 ± 3.5 (13) in CTRL. Mean prostate volume (mL) remained stable from 32.1 ± 9.1 to 31.6 ± 9.9 after 16 years in the T-group and from 35.6 ± 6.7 to 36.7 ± 5.9 in CTRL. The estimated adjusted difference between groups was statistically non-significant. Mean PSA (ng/mL) remained stable from 2.1 ± 1.0 to 1.9 ± 0.9 after 16 years in the T-group and increased from 2.5 ± 1.4 to 3.5 ± 1.2 in CTRL (p < 0.0001). The estimated adjusted difference between groups was -1.6 (95% CI: -2.2;-1.1) (p < 0.0001). In the T-group, 13 patients (3.2%) were diagnosed with PCa. Every single PCa diagnosis was made within 18 months from the day of the first testosterone injection to the day of the biopsy resulting in PCa diagnosis. In CTRL, 62 (14.9%) patients were diagnosed with PCa (p < 0.0001 between groups). Among the patients diagnosed with PCa, there was no biochemical recurrence in the T-group where all men were treated by radical prostatectomy. In CTRL, 25 men (6.0%) had one biochemical recurrence of PCa (p < 0.0001 between groups). Among patients in CTRL with a biochemical recurrence, 3 men (0.7%) had a second biochemical recurrence. In the T-group, one patient (0.2%) had an AUR. In CTRL, 23 patients (5.5%) had an AUR during the observation time (p < 0.0001 between groups). In the T-group, 60 men (14.7%) died. In CTRL, 171 patients (41.2%) died during the follow-up period (p < 0.0001 between groups). Conclusions Long-term TTh in men with functional hypogonadism was associated with the incidence of less adverse urological events and lower all-cause mortality, compared to an untreated control. Because of the observational design of the registry study, these findings have to be interpreted with caution. Disclosure Yes, this is sponsored by industry/sponsor: Gruenenthal GmbH, Aachen, Germany. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Gruenenthal GmbH, Aachen, Germany.