Dataset Information

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.

SUBMITTER: Malek R

PROVIDER: S-EPMC8899139 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Publications

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

Malek Rohan R Wu Sheng-Tang ST Serrano Dennis D Tho Tran T Umbas Rainy R Teoh Jeremy J Lojanapiwat Bannakji B Ong Teng Aik TA On Weber Kam WK Thai Sam Minh SM Kim Janet J Pophale Rupesh R Chiong Edmund E

Translational andrology and urology 20220201 2

<h4>Background</h4>The incidence and mortality rate of men with prostate cancer have been increasing in Asia. ELIGARD<sup>®</sup> 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.<h4>Methods</h4>ELIGANT (ELIGard AsiaN sTudy) was a Phase 4, multicenter, prospective, single-arm, interventional study. Men with locally advanced or metastatic prostate cancer without concomi ...[more]

PMID: 35280654

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Dataset Information

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

Background

Methods

Results

Conclusions

Trial registration

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

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

Background

Methods

Results

Conclusions

Trial registration

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

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