A prospective, randomized, cross-over trial to assess patient preference for goserelin microsphere versus goserelin implant in prostate cancer: Interim results of the GOMIMP study.

作者：Xuegang Wang, Jinchun Xing, Bin Chen, Kaiyan Zhang, Zhun Wu, Wei Li, Lingyan Gao, Zhongjie Zhao, Peide Bai · 发表于：Journal of Clinical Oncology · 年份：2026 · DOI：10.1200/jco.2026.44.7_suppl.130 · 被引用次数：1 · 研究领域：Prostate Cancer Diagnosis and Treatment、Prostate Cancer Treatment and Research、Sperm and Testicular Function

130 Background: Androgen deprivation therapy (ADT), particularly gonadotropin-releasing hormone (GnRH) agonists like goserelin, remains a cornerstone in prostate cancer management. While the goserelin implant (Zoladex 3.6 mg) requires subcutaneous administration via a 16G needle (1.6 mm outer diameter) every 28 days, the goserelin microsphere formulation (LY01005 3.6 mg) is administered intramuscularly using a narrower 21G needle (0.8 mm outer diameter) at the same interval. Although phase III data (NCT04563936) confirmed comparable efficacy and safety between these formulations, patient preference remains unexplored. This GOMIMP study evaluates patient preference for the two formulations of goserelin. Methods: In this ongoing crossover trial (NCT06385847), 60 prostate cancer patients are randomized 1:1 to receive either goserelin implant (s.c., 3.6 mg every 28 days for 2 cycles) followed by goserelin microsphere (i.m., 3.6 mg every 28 days for 2 cycles) [Arm 1], or vice versa [Arm 2]. The primary endpoint is patient preference assessed via questionnaire post-treatment. Secondary endpoints include preference rationale, injection tolerability (assessed via Visual Analogue Scale [VAS]), adverse events (AEs), and health-related quality of life (HRQoL). Results: Among 60 enrolled patients, 39 completed both treatment periods and were evaluable. No participants reported “no preference”. Goserelin microsphere was preferred by 35 (89.7%) patients versus 4 (10.3%) patients for the go...