A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients
A Phase IV Interventional Safety Study of ELIGARD® in Prostate Cancer Patients in Asia (ELIGANT)
1 other identifier
interventional
107
8 countries
19
Brief Summary
The objective of this study was to evaluate the safety profile of ELIGARD® in ethnic Asian prostate cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 prostate-cancer
Started Jun 2017
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2017
CompletedFirst Posted
Study publicly available on registry
January 27, 2017
CompletedStudy Start
First participant enrolled
June 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2019
CompletedResults Posted
Study results publicly available
December 9, 2020
CompletedNovember 26, 2024
October 1, 2024
2.4 years
January 25, 2017
November 13, 2020
November 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Eligard Related Adverse Events (AE)
An AE was defined as any untoward medical occurrence in a participant administered a study drug or had undergone study procedures that did not necessarily have a causal relationship with this treatment. An AE was considered to be serious if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization, other medically important events. Drug-related AEs are AEs where causal relationships were at least a reasonable possibility as determined by the investigator.
From first dose of study drug up to 18 months
Secondary Outcomes (11)
Percentage of Participants With Testosterone Levels Less Than (<) 20, 20-50 and Greater Than (>) 50 Nanogram Per Deciliter (ng/dL) at Month 12
Month 12
Percentage of Participants With Testosterone Levels < 20, 20-50 and > 50 ng/dL at Month 18
Month 18
Time to PSA Progression
From first dose of study drug up to PSA progression (18 months)
Percentage of Participants With Greater Than or Equal to (≥) 30% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18
Months 3, 6, 9, 12, 15 and 18
Percentage of Participants With ≥50% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18
Months 3, 6, 9, 12, 15 and 18
- +6 more secondary outcomes
Study Arms (1)
Leuprolide Acetate 22.5 milligrams (mg)
EXPERIMENTALParticipants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
Interventions
Eligibility Criteria
You may qualify if:
- A patient for whom the physician has decided to initiate treatment with a Luteinizing Hormone Releasing Hormone (LHRH) agonist in standard clinical practice
- Biopsy-proven prostate adenocarcinoma
- Locally advanced prostate cancer with biochemical relapse radical prostatectomy and/or radiotherapy, OR hormonal treatment-naive advanced or metastatic prostate cancer patient who has not received chemotherapy and has no plans to undergo treatment with chemotherapy at study entry.
- Patient who indicates that once the study is completed, he expects having access to androgen deprivation therapy (ADT), either medical or surgical, within the local healthcare system (either through public/ private health insurance or out of pocket payment).
You may not qualify if:
- Patient with castrate resistant prostate cancer
- Patient who previously underwent bilateral orchiectomy
- Patient who has received prior treatment with LHRH analogues
- Prior or concomitant treatment with systemic chemotherapy. A patient where there is a likelihood to receive systemic chemotherapy should not be enrolled
- Life expectancy of \< 1 year due to comorbidities
- Participation in another interventional clinical trial within one month prior to study entry or during the duration of the study
- Patient who plans to receive intermittent ADT at the time of study entry
- Patient receiving non-palliative radiotherapy within 3 months prior to study entry
- Patient receiving adjuvant ADT in combination with definitive radiotherapy
- Patient with metastatic hormonal treatment-naive prostate cancer, for whom chemo-hormonal treatment (combination of Docetaxel and ADT) is indicated.
- Patient with hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonist analogs or any of the components of ELIGARD®
- Patient with any contraindication for ELIGARD® use based on local prescribing information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Site HK01001
Hong Kong, Hong Kong
Site HK01002
Hong Kong, Hong Kong
Site ID02001
Jakarta, DKI Jakarta, Indonesia
Site MY03002
Batu Caves, Selangor, Malaysia
Site MY03001
Kuala Lumpur, Malaysia
Site PH04001
Makati City, National Capital Region, Philippines
Site PH04003
Manila, National Capital Region, Philippines
Site PH04002
San Juan City, National Capital Region, Philippines
Site SG05001
Singapore, Singapore
Site SG05002
Singapore, Singapore
Site SG05003
Singapore, Singapore
Site TW06001
Taichung, Taiwan
Site TW06002
Taichung, Taiwan
Site TW06003
Taipei, Taiwan
Site TH07004
Hat Yai, Changwat Songkhla, Thailand
Site TH07001
Muang, Chiang Mai, Thailand
Site TH07003
Bangkok, Thailand
Site VN08001
Ho Chi Minh City, Vietnam
Site VN08002
Ho Chi Minh City, Vietnam
Related Publications (1)
Malek R, Wu ST, Serrano D, Tho T, Umbas R, Teoh J, Lojanapiwat B, Ong TA, On WK, Thai SM, Kim J, Pophale R, Chiong E. ELIGANT: a Phase 4, interventional, safety study of leuprorelin acetate (ELIGARD(R)) in Asian men with prostate cancer. Transl Androl Urol. 2022 Feb;11(2):179-189. doi: 10.21037/tau-21-723.
PMID: 35280654DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure
- Organization
- Astellas Pharma Sinagpore Pte Ltd
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2017
First Posted
January 27, 2017
Study Start
June 23, 2017
Primary Completion
November 19, 2019
Study Completion
November 19, 2019
Last Updated
November 26, 2024
Results First Posted
December 9, 2020
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.