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A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Leuprolide
Sponsored by
Astellas Pharma Singapore Pte. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Leuprolide acetate, Prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Site HK01001
  • Site HK01002
  • Site ID02001
  • Site MY03002
  • Site MY03001
  • Site PH04001
  • Site PH04003
  • Site PH04002
  • Site SG05001
  • Site SG05002
  • Site SG05003
  • Site TW06001
  • Site TW06002
  • Site TW06003
  • Site TH07001
  • Site TH07004
  • Site TH07003
  • Site VN08001
  • Site VN08002

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Leuprolide Acetate 22.5 milligrams (mg)

Arm Description

Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).

Full Information

First Posted
January 25, 2017
Last Updated
January 17, 2021
Sponsor
Astellas Pharma Singapore Pte. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03035032
Brief Title
A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients
Official Title
A Phase IV Interventional Safety Study of ELIGARD® in Prostate Cancer Patients in Asia (ELIGANT)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 23, 2017 (Actual)
Primary Completion Date
November 19, 2019 (Actual)
Study Completion Date
November 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Singapore Pte. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Leuprolide acetate, Prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Leuprolide Acetate 22.5 milligrams (mg)
Arm Type
Experimental
Arm Description
Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
Intervention Type
Drug
Intervention Name(s)
Leuprolide
Other Intervention Name(s)
Eligard
Intervention Description
Subcutaneous Injection
Primary Outcome Measure Information:
Title
Number of Participants With Eligard Related Adverse Events (AE)
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.
Time Frame
From first dose of study drug up to 18 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With Testosterone Levels Less Than (<) 20, 20-50 and Greater Than (>) 50 Nanogram Per Deciliter (ng/dL) at Month 12
Description
Testosterone level was summarized based on the percentage of participants with < 20 ng/dL, 20 to 50 ng/dL and > 50 ng/dL.
Time Frame
Month 12
Title
Percentage of Participants With Testosterone Levels < 20, 20-50 and > 50 ng/dL at Month 18
Description
Testosterone level was summarized based on the percentage of participants with < 20 ng/dL, 20 to 50 ng/dL and > 50 ng/dL.
Time Frame
Month 18
Title
Time to PSA Progression
Description
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.
Time Frame
From first dose of study drug up to PSA progression (18 months)
Title
Percentage of Participants With Greater Than or Equal to (≥) 30% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18
Description
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.
Time Frame
Months 3, 6, 9, 12, 15 and 18
Title
Percentage of Participants With ≥50% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18
Description
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.
Time Frame
Months 3, 6, 9, 12, 15 and 18
Title
Percentage of Participants With ≥90% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18
Description
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.
Time Frame
Months 3, 6, 9, 12, 15 and 18
Title
Change From Baseline in EQ-5D-5L Health State Utility Index Score (Japan) at Months 6, 12 and 18
Description
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.
Time Frame
Baseline, months 6, 12 and 18
Title
Change From Baseline in EQ-5D-5L Health Status Utility Index Score (UK) at Months 6, 12 and 18
Description
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.
Time Frame
Baseline, months 6, 12 and 18
Title
Change From Baseline in EQ-5D-5L Health Status Utility Index Score (US) at Months 6, 12 and 18
Description
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.
Time Frame
Baseline, months 6, 12 and 18
Title
Change From Baseline in EQ-5D02-EQ-VAS Score at Months 6, 12 and 18
Description
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.
Time Frame
Baseline, months 6, 12 and 18
Title
Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18
Description
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).
Time Frame
Baseline, months 6, 12 and 18

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
Facility Name
Site HK01001
City
Hong Kong
Country
Hong Kong
Facility Name
Site HK01002
City
Hong Kong
Country
Hong Kong
Facility Name
Site ID02001
City
Jakarta
State/Province
DKI Jakarta
Country
Indonesia
Facility Name
Site MY03002
City
Batu Caves
State/Province
Selangor
Country
Malaysia
Facility Name
Site MY03001
City
Kuala Lumpur
Country
Malaysia
Facility Name
Site PH04001
City
Makati City
State/Province
Metro Manila
Country
Philippines
Facility Name
Site PH04003
City
Manila
State/Province
Metro Manila
Country
Philippines
Facility Name
Site PH04002
City
San Juan
State/Province
Metro Manila
Country
Philippines
Facility Name
Site SG05001
City
Singapore
Country
Singapore
Facility Name
Site SG05002
City
Singapore
Country
Singapore
Facility Name
Site SG05003
City
Singapore
Country
Singapore
Facility Name
Site TW06001
City
Taichung
Country
Taiwan
Facility Name
Site TW06002
City
Taichung
Country
Taiwan
Facility Name
Site TW06003
City
Taipei
Country
Taiwan
Facility Name
Site TH07001
City
Muang
State/Province
Chiang Mai
Country
Thailand
Facility Name
Site TH07004
City
Hat Yai
State/Province
Songkhla
Country
Thailand
Facility Name
Site TH07003
City
Bangkok
Country
Thailand
Facility Name
Site VN08001
City
Ho Chi Minh City
Country
Vietnam
Facility Name
Site VN08002
City
Ho Chi Minh City
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD Sharing Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
35280654
Citation
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.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=395
Description
Link to results on the Astellas Clinical Study Results website.

Learn more about this trial

A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients

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