ELIGANT: a Phase 4, interventional, safety study of leuprorelin acetate (ELIGARD®) in Asian men with prostate cancer

Abstract

Background: The incidence and mortality rate of men with prostate cancer have been increasing in Asia. ELIGARD^® is a formulation of leuprorelin acetate whose safety and efficacy have been well-established in Western regions. However, limited safety data are available for Asian populations.

Methods: ELIGANT (ELIGard AsiaN sTudy) was a Phase 4, multicenter, prospective, single-arm, interventional study. Men with locally advanced or metastatic prostate cancer without concomitant chemotherapy, or another androgen receptor pathway inhibitor, were enrolled across Asia to receive ELIGARD^® (22.5 mg subcutaneous depot injection) every 3 months for 15 months, with a follow-up visit at 18 months. The primary objective was to establish the safety of ELIGARD^® in Asian men with hormone-dependent prostate cancer. The secondary objectives were to assess efficacy, via prostate-specific antigen (PSA) progression and testosterone levels, and health-related quality of life (HRQoL).

Results: In total, 106 patients were included in the safety analysis set (SAF). The most common treatment-emergent adverse events (TEAEs) included PSA increase, cough, back pain, hot flush, anemia, and upper respiratory tract infection. TEAEs considered related to ELIGARD^® were reported in 13.2% of patients (n=14), two of which were serious. In the full analysis set (FAS) (n=105), 81.2% (n=56) and 68.5% (n=61) of patients achieved a PSA reduction of ≥90% from baseline at 12 and 18 months, respectively. At 18 months, the numbers of patients with testosterone levels <20, 20-50, and >50 ng/dL were 65 (61.9%), 17 (16.2%), and two (1.9%), respectively; 20% had missing testosterone measurements. HRQoL remained stable throughout the study with minimal change from baseline at study completion.

Conclusions: In conclusion, the safety profile of ELIGARD^® (22.5 mg) in Asian men with hormone-dependent prostate cancer is comparable to previous studies in Western regions.

Trial registration: Clinical trial registration number NCT03035032.

Keywords: Depot formulation; leuprolide acetate; prostate cancer; prostate-specific antigen (PSA).

Figure 1

Study design overview. PSA, prostate-specific antigen; T, testosterone; HRQoL, health-related quality of life.

Figure 2

CONSORT diagram. SAF, safety analysis set; FAS, full analysis set; PPS, per-protocol set.

Figure 3

HRQoL EORTC QLQ-252 and EQ-5D-5L scores. Mean changes in EORTC QLQ-252 and EQ-5D-5L scores from baseline suggested that stable HRQoL was maintained with 18 months of active treatment. (A) FAS (n=105). Mean (SD) improvements from baseline were observed in EORTC QLQ-252 scores across all patients for urinary symptoms after 18 months. Mean (SD) increases from baseline EORTC QLQ-252 scores were observed for incontinence, bowel symptoms, and hormone-treatment related symptoms. Mean (SD) decreases from baseline EORTC QLQ-252 scores were observed for sexual activity and sexual function. There were minimal changes in EQ-5D-5L scores from baseline at 18 months. (B) PPS (n=65). Similarly, improvements in urinary symptoms from baseline were observed after 18 months, and mean (SD) increases from baseline were observed for incontinence, bowel symptoms, and hormone treatment-related symptoms. As in the FAS mean scores for sexual activity and sexual function decreased after 18 months. Again, there were minimal changes in EQ-5D-5L scores from baseline at 18 months. HRQoL, health-related quality of life; EORTC QLQ-252, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Cancer module; EQ-5D-5L, European Quality of Life 5-Dimension, 5-Level questionnaire; VAS, visual analog scale; SD, standard deviation; FAS, full analysis set; PPS. per-protocol set.