Clinical trial · Interventional
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)
NCT03035032CI-TRIAL-00083007completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study was to evaluate the safety profile of ELIGARD® in ethnic Asian prostate cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuprolide | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Leuprolide Acetate 22.5 milligrams (mg)
- description
- Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
- interventionNames
- Drug: Leuprolide
Primary outcomes (1)
- measure
- Number of Participants With Eligard Related Adverse Events (AE)
- timeFrame
- From first dose of study drug up to 18 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDMalek 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 35280654