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

Phase 4CompletedNCT03035032

Astellas Pharma Singapore Pte. Ltd.107 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

107

Conditions

Prostate Cancer

Interventions

LeuprolideDRUG

Subcutaneous Injection

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Site HK01001

Hong Kong, Hong Kong

Site HK01002

Hong Kong, Hong Kong

Site ID02001

Jakarta, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

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.

Time frame: From first dose of study drug up to 18 months

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

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

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 frame: 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.

Data from ClinicalTrials.gov

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Site MY03002

Batu Caves, Selangor, Malaysia

Site MY03001

Kuala Lumpur, Malaysia

Site PH04001

Makati City, National Capital Region, Philippines

Site PH04003

Manila, National Capital Region, Philippines

Site PH04002

San Juan City, National Capital Region, Philippines

Site SG05001

Singapore, Singapore

Site SG05002

Singapore, Singapore

...and 9 more locations

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

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

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.

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

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

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.