CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 107 enrolled
Drug / intervention
Leuprolidedrug
Likely dose
Leuprolide (ELIGARD) - subcutaneous injection, dose not specified in criteria or armsAI-extracted
Key inclusion· 4
  • Biopsy-proven prostate adenocarcinoma
  • Locally advanced prostate cancer with biochemical relapse after radical prostatectomy and/or radiotherapy, OR hormonal treatment-naive advanced or metastatic prostate cancer without prior chemotherapy and no plans for chemotherapy at study entry
  • Physician has decided to initiate LHRH agonist treatment in standard clinical practice
  • Patient expects access to androgen deprivation therapy (ADT) after study completion within local healthcare system
Key exclusion· 10
  • Castrate-resistant prostate cancer
  • Prior treatment with LHRH analogues
  • Prior or concomitant systemic chemotherapy, or likelihood of receiving chemotherapy during study
  • Prior bilateral orchiectomy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03035032
NCT03035032Phase 4Completed

A Phase IV Interventional Safety Study of ELIGARD® in Prostate Cancer Patients in Asia (ELIGANT)

Astellas Pharma Singapore Pte. Ltd.·interventional·Posted Jan 27, 2017·Updated Nov 26, 2024

In Brief

A Phase 4 clinical trial evaluating Leuprolide for Prostate Cancer. Completed, enrolled 107 participants across 19 sites in 8 countries.

Detailed Summary

The objective of this study was to evaluate the safety profile of ELIGARD® in ethnic Asian prostate cancer patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesHong Kong, Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 27, 2017
Enrollment StartJun 23, 2017
Primary CompletionNov 19, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.4 years ago

Interventions

Leuprolidedrug

Subcutaneous Injection