Real-world effectiveness and safety of goserelin 10.8-mg depot in Chinese patients with localized or locally advanced prostate cancer

Objective: Real -word data on long -acting luteinizing hormone -releasing hormone (LHRH) agonists in Chinese patients with prostate cancer are limited. This study aimed to determine the real -world effectiveness and safety of the LHRH agonist, goserelin, particularly the long -acting 10.8 -mg depot formulation, and the follow-up patterns among Chinese prostate cancer patients. Methods: This was a multicenter, prospective, observational study in hormone treatment -naive patients with localized or locally advanced prostate cancer who were prescribed goserelin 10.8 -mg depot every 12 weeks or 3.6 -mg depot every 4 weeks with or without an anti -androgen. The patients had follow-up evaluations for 26 weeks. The primary outcome was the effectiveness of goserelin in reducing serum testosterone and prostate -specific antigen (PSA) levels. The secondary outcomes included testosterone and PSA levels, attainment of chemical castration (serum testosterone <50 ng/dL), and goserelin safety. The exploratory outcome was the monitoring pattern for serum testosterone and PSA. All analyses were descriptive. Results: Between September 2017 and December 2019, a total of 294 eligible patients received >= 1 dose of goserelin; 287 patients (97.6%) were treated with goserelin 10.8 -mg depot. At week 24 +/- 2, the changes from baseline [standard deviation (95% confidence interval)] in serum testosterone (n = 99) and PSA (n = 131) were -401.0 ng/dL [308.4 ng/dL (-462.5, -339.5 ng/dL)] and -35.4 ng/mL [104.4 ng/mL (-53.5, -17.4 ng/mL)], respectively. Of 112 evaluable patients, 100 (90.2%) achieved a serum testosterone level < 50 ng/dL. Treatment -emergent adverse events (TEAEs) and severe TEAEs occurred in 37.1% and 10.2% of patients, respectively. The mean testing frequency (standard deviation) was 1.6 (1.5) for testosterone and 2.2 (1.6) for PSA. Conclusions: Goserelin 10.8 -mg depot effectively achieved and maintained castration and was well -tolerated in Chinese patients with localized and locally advanced prostate cancer.