Phase 4
Completed N=107
A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients
Source: ClinicalTrials.gov NCT03035032 ↗Enrolled (actual)
107
Serious AEs
29.3%
Results posted
Dec 2020
Primary outcomePrimary: Number of Participants With Eligard Related Adverse Events (AE) — 15; 2 Participants
◆ Published Evidence
Emerging
9citations · ~2 / year
ELIGANT: a Phase 4, interventional, safety study of leuprorelin acetate (ELIGARD<sup>®</sup>) in Asian men with prostate cancer.
Summary
The objective of this study was to evaluate the safety profile of ELIGARD® in ethnic Asian prostate cancer patients.
Linked Publications
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ELIGANT: a Phase 4, interventional, safety study of leuprorelin acetate (ELIGARD<sup>®</sup>) in Asian men with prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Eligard Related Adverse Events (AE) |
15; 2 | — |
| SECONDARY Percentage of Participants With Testosterone Levels Less Than (<) 20, 20-50 and Greater Than (>) 50 Nanogram Per Deciliter (ng/dL) at Month 12 |
51.4; 12.4; 1.9 | — |
| SECONDARY Percentage of Participants With Testosterone Levels < 20, 20-50 and > 50 ng/dL at Month 18 |
61.9; 16.2; 1.9 | — |
| SECONDARY Time to PSA Progression |
8.80 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to (≥) 30% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 |
96.1; 93.8; 92.8; 97.1; 98.4; 91.0 | — |
| SECONDARY Percentage of Participants With ≥50% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 |
89.2; 91.7; 91.6; 94.2; 96.9; 88.8 | — |
| SECONDARY Percentage of Participants With ≥90% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18 |
69.6; 77.1; 77.1; 81.2; 79.7; 68.5 | — |
| SECONDARY Change From Baseline in EQ-5D-5L Health State Utility Index Score (Japan) at Months 6, 12 and 18 |
-0.0047; -0.0093; -0.0262 | — |
| SECONDARY Change From Baseline in EQ-5D-5L Health Status Utility Index Score (UK) at Months 6, 12 and 18 |
0.0055; -0.0051; -0.0259 | — |
| SECONDARY Change From Baseline in EQ-5D-5L Health Status Utility Index Score (US) at Months 6, 12 and 18 |
0.0017; -0.0047; -0.0191 | — |
| SECONDARY Change From Baseline in EQ-5D02-EQ-VAS Score at Months 6, 12 and 18 |
1.3; 2.1; 2.0 | — |
| SECONDARY Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18 |
-4.84; -5.21; -2.17; 3.27; -6.08; -1.44 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03035032) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.