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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03035032
• Other study ID #: 7015-MA-3072
• Status: Completed
• Phase: Phase 4
• Start date: June 23, 2017
• Est. completion date: November 19, 2019

Study information

• Verified date: January 2021
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: November 19, 2019
• Est. primary completion date: November 19, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Leuprolide
Subcutaneous Injection

Locations

Country	Name	City	State
Hong Kong	Site HK01001	Hong Kong
Hong Kong	Site HK01002	Hong Kong
Indonesia	Site ID02001	Jakarta	DKI Jakarta
Malaysia	Site MY03002	Batu Caves	Selangor
Malaysia	Site MY03001	Kuala Lumpur
Philippines	Site PH04001	Makati City	Metro Manila
Philippines	Site PH04003	Manila	Metro Manila
Philippines	Site PH04002	San Juan	Metro Manila
Singapore	Site SG05001	Singapore
Singapore	Site SG05002	Singapore
Singapore	Site SG05003	Singapore
Taiwan	Site TW06001	Taichung
Taiwan	Site TW06002	Taichung
Taiwan	Site TW06003	Taipei
Thailand	Site TH07003	Bangkok
Thailand	Site TH07004	Hat Yai	Songkhla
Thailand	Site TH07001	Muang	Chiang Mai
Vietnam	Site VN08001	Ho Chi Minh City
Vietnam	Site VN08002	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Singapore Pte. Ltd.

Countries where clinical trial is conducted

Hong Kong,  Indonesia,  Malaysia,  Philippines,  Singapore,  Taiwan,  Thailand,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From first dose of study drug up to 18 months
Secondary	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.	Month 12
Secondary	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.	Month 18
Secondary	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.	From first dose of study drug up to PSA progression (18 months)
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	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.	Months 3, 6, 9, 12, 15 and 18
Secondary	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.	Months 3, 6, 9, 12, 15 and 18
Secondary	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.	Months 3, 6, 9, 12, 15 and 18
Secondary	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.	Baseline, months 6, 12 and 18
Secondary	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.	Baseline, months 6, 12 and 18
Secondary	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.	Baseline, months 6, 12 and 18
Secondary	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.	Baseline, months 6, 12 and 18
Secondary	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).	Baseline, months 6, 12 and 18

External Links

•   Link to results on the Astellas Clinical Study Results website.