A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients
NCT ID: NCT03035032
Last Updated: 2024-11-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
107 participants
INTERVENTIONAL
2017-06-23
2019-11-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD
NCT00378690
An Observational Study Looking at How Well the Drug Eligard Works and How Well it is Tolerated by the Body of Patients With Advanced Prostate Carcinoma in the Russian Federation
NCT02128334
Study to Evaluate the Safety and Efficacy of Switching From Zoladex® Monthly or Quarterly, to Eligard® Semiannual.
NCT05304169
A Study in Patients With Metastatic Prostate Cancer to Assess How the Drug Eligard®, Affects Certain Markers in Blood and Urine, Which Are Indicators for the Disease
NCT01933022
A Six-Month, Open-Label, Crossover Study Of the Maintenance Of Serum Testosterone And PSA Suppression After Switching Between Lupron 22.5 Mg And Eligard 22.5 Mg Or Zoladex 10.8 Mg And Eligard 22.5 Mg In Patients With Advanced Prostate Cancer
NCT00220194
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Leuprolide Acetate 22.5 milligrams (mg)
Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
Leuprolide
Subcutaneous Injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Leuprolide
Subcutaneous Injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Astellas Pharma Singapore Pte. Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Inc
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Link to results on the Astellas Clinical Study Results website.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
7015-MA-3072
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.