Prostate CancerPhase 4NCT03035032
A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients
A Phase 4 study testing Leuprolide in people with Prostate Cancer, run by Astellas Pharma Singapore Pte. Ltd. at 19 sites in 8 countries.
Trial summary
The objective of this study was to evaluate the safety profile of ELIGARD® in ethnic Asian prostate cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Leuprolide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 19 sitesin 8 countries
- Study dates
- 23 Jun 2017to 19 Nov 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
Philippines3 sites
Site PH04001
Makati City, National Capital Region
Site PH04003
Manila, National Capital Region
Site PH04002
San Juan City, National Capital Region
Singapore3 sites
Site SG05001
Singapore
Site SG05002
Singapore
Site SG05003
Singapore
Thailand3 sites
Site TH07003
Bangkok
Site TH07004
Hat Yai, Changwat Songkhla
Site TH07001
Muang, Chiang Mai
About this study
Official title: A Phase IV Interventional Safety Study of ELIGARD® in Prostate Cancer Patients in Asia (ELIGANT)
The objective of this study was to evaluate the safety profile of ELIGARD® in ethnic Asian prostate cancer patients.
- Conditions
- Prostate Cancer
- Being tested
- Leuprolide
- Keywords
- Leuprolide acetate, Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeuprolideDrug
Also called Eligard
Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Leuprolide Acetate 22.5 milligrams (mg) | Experimental | Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15. Receives: Drug: Leuprolide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Testosterone level was summarized based on the percentage of participants with < 20 ng/dL, 20 to 50 ng/dL and > 50 ng/dL.
Measured: Month 12
Percentage of Participants With Testosterone Levels < 20, 20-50 and > 50 ng/dL at Month 18
Testosterone level was summarized based on the percentage of participants with < 20 ng/dL, 20 to 50 ng/dL and > 50 ng/dL.
Measured: Month 18
Time to PSA Progression
Time to PSA progression was defined as (date of ≥25 percentage (%) increase and ≥ 2 ng/mL absolute increase) - (date of first administration of ELIGARD 22.5 mg)/30, where PSA progression was defiined as 25% or greater increase and an absolute increase of 2 ng/mL, and confirmed by a second value at least 3 weeks later. Participants with more than 1 qualifying PSA progression were counted only once, and the earlier progression was accounted for time to progression analysis.
Measured: 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
PSA percent reduction (%) = ([PSA tested- baseline PSA]/baseline PSA)*100%. PSA level was summarized based on time to PSA progression and PSA percent reduction by ≥ 30% with respect to the level at baseline. Participants with more than 1 qualifying PSA progression were counted only once, and the earlier progression was accounted for time to progression analysis. PSA progression was defined as 25% or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL), and confirmed by a second value at least 3 weeks later.
Measured: 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
PSA percent reduction (%) = ([PSA tested- baseline PSA]/baseline PSA)*100%. PSA level was summarized based on time to PSA progression and PSA percent reduction by ≥ 50% with respect to the level at baseline. Participants with more than 1 qualifying PSA progression were counted only once, and the earlier progression was accounted for time to progression analysis. PSA progression was defined as 25% or greater increase and an absolute increase of 2 ng/mL, and confirmed by a second value at least 3 weeks later.
Measured: Months 3, 6, 9, 12, 15 and 18
Percentage of Participants With ≥90% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18
PSA percent reduction (%) = ([PSA tested- baseline PSA]/baseline PSA)*100%. PSA level was summarized based on time to PSA progression and PSA percent reduction by ≥ 90%, with respect to the level at baseline. Participants with more than 1 qualifying PSA progression were counted only once, and the earlier progression was accounted for time to progression analysis. PSA progression was defined as 25% or greater increase and an absolute increase of 2 ng/mL, and confirmed by a second value at least 3 weeks later.
Measured: Months 3, 6, 9, 12, 15 and 18
Change From Baseline in EQ-5D-5L Health State Utility Index Score (Japan) at Months 6, 12 and 18
EQ-5D-5L is a standardized instrument for use as a measure of health outcome and provides a simple descriptive profile and a single index value for health status. EQ-5D-5L is designed for self-completion by respondents and consists of 2 pages comprising the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension of the EQ-5D-5L has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) and the participant was asked to indicate his health state by ticking the box with the most appropriate statement. Index scores were generated using Japan value sets. Scores ranged from -0.111 to 1. Higher scores indicate better health state.
Measured: Baseline, months 6, 12 and 18
Change From Baseline in EQ-5D-5L Health Status Utility Index Score (UK) at Months 6, 12 and 18
EQ-5D-5L is a standardized instrument for use as a measure of health outcome and provides a simple descriptive profile and a single index value for health status. EQ-5D-5L is designed for self-completion by respondents and consists of 2 pages comprising the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension of the EQ-5D-5L has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) and the participant was asked to indicate his health state by ticking the box with the most appropriate statement. Index scores were generated using UK value sets. Scores ranged from -0.594 to 1. Higher scores indicate better health state.
Measured: Baseline, months 6, 12 and 18
Change From Baseline in EQ-5D-5L Health Status Utility Index Score (US) at Months 6, 12 and 18
EQ-5D-5L is a standardized instrument for use as a measure of health outcome and provides a simple descriptive profile and a single index value for health status. EQ-5D-5L is designed for self-completion by respondents and consists of 2 pages comprising the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension of the EQ-5D-5L has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) and the participants was asked to indicate his health state by ticking the box with the most appropriate statement. Index scores were generated using US value sets. Scores ranged from -0.109 to 1. Higher scores indicate better health state.
Measured: Baseline, months 6, 12 and 18
Change From Baseline in EQ-5D02-EQ-VAS Score at Months 6, 12 and 18
The EQ5D02-EQ-VAS is a vertical VAS with values between 0 (worst imaginable health) and 100 (best imaginable health), on which participants provide a global assessment of their health. Higher score indicate better health state.
Measured: Baseline, months 6, 12 and 18
Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18
EORTC QLQ-PR25 is a prostate cancer module for the assessment of health-related quality of life (HRQoL). EORTC QLQ-PR25 is designed for self-completion by respondents and assesses urinary symptoms, bowel symptoms, treatment-related symptoms and sexual activity and functioning. The rule of scoring for EORTC QLQ-PR25 follows instruction of EORTC QLQ-PR25 Scoring Manual 2.0. It consist of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).
Measured: Baseline, months 6, 12 and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start23 Jun 2017
- Primary completion19 Nov 2019
- Study completion19 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Singapore Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035032
- Sponsor's protocol ID
- 7015-MA-3072
- Status last verified
- Oct 2024
- First submitted
- 25 Jan 2017
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/.
Publications
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.
PubMed 35280654
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Interventional Safety Study of ELIGARD® in Prostate Cancer Patients in Asia (ELIGANT)
- ClinicalTrials.gov ID
- NCT03035032
- Acronym / sponsor ID
- 7015-MA-3072
- Conditions
- Prostate Cancer
- Keywords
- Leuprolide acetate, Prostate cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Astellas Pharma Singapore Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Posted 9 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to evaluate the safety profile of ELIGARD® in ethnic Asian prostate cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leuprolide Acetate 22.5 milligrams (mg) | Experimental | Drug: LeuprolideParticipants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeuprolideAlso: EligardSubcutaneous Injection | Drug | Leuprolide Acetate 22.5 milligrams (mg) |
Primary outcome
Number of Participants With Eligard Related Adverse Events (AE)
Time frame: From first dose of study drug up to 18 months
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.
11 secondary outcomes
Percentage of Participants With Testosterone Levels Less Than (<) 20, 20-50 and Greater Than (>) 50 Nanogram Per Deciliter (ng/dL) at Month 12
Time frame: Month 12
Percentage of Participants With Testosterone Levels < 20, 20-50 and > 50 ng/dL at Month 18
Time frame: Month 18
Time to PSA Progression
Time frame: 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
Time frame: 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
Time frame: Months 3, 6, 9, 12, 15 and 18
Percentage of Participants With ≥90% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18
Time frame: Months 3, 6, 9, 12, 15 and 18
Change From Baseline in EQ-5D-5L Health State Utility Index Score (Japan) at Months 6, 12 and 18
Time frame: Baseline, months 6, 12 and 18
Change From Baseline in EQ-5D-5L Health Status Utility Index Score (UK) at Months 6, 12 and 18
Time frame: Baseline, months 6, 12 and 18
Change From Baseline in EQ-5D-5L Health Status Utility Index Score (US) at Months 6, 12 and 18
Time frame: Baseline, months 6, 12 and 18
Change From Baseline in EQ-5D02-EQ-VAS Score at Months 6, 12 and 18
Time frame: Baseline, months 6, 12 and 18
Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18
Time frame: Baseline, months 6, 12 and 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35280654Malek 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.
- Individual participant dataSharing planned: Yes. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Inc
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Leuprolide in people with Prostate Cancer, run by Astellas Pharma Singapore Pte. Ltd. at 19 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Philippines, Singapore, Taiwan, Thailand, Hong Kong and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Eligard Related Adverse Events (AE) (time frame: From first dose of study drug up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03035032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.