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Submitted by: Quintiles 2017-05-18 00:00:00 Last Updated by: Quintiles 2020-11-05 12:15:36


A Phase IV Interventional Safety, Efficacy and Quality of Life Study of ELIGARD® in Prostate Cancer Patients in Asia (ELIGANT)

PHRR170519-001545

7015-MA-3072

2016 - CT0385

A Phase IV Interventional Safety, Efficacy and Quality of Life Study of ELIGARD® in Prostate Cancer Patients in Asia (ELIGANT)

This is a multicenter, prospective, single-arm, interventional study of male patients with prostate adenocarcinoma who fulfill the eligibility criteria.The planned total duration of this study is 36 months from the date that the first patient is enrolled. The enrollment period will be up to 18 months.This study is designed for male patients with:> locally advanced prostate cancer with biochemical relapse following radical prostatectomy or radiotherapy; and> hormonal treatment-naive advanced or metastatic prostate cancerApproximately 15 centers in 8 Asian Countries and number of patients to be enrolled is 107.Primary Objective:To establish the safety profile of ELIGARD® in ethnic Asian prostate cancer patientsSecondary Objectives:(i) To describe the efficacy of ELIGARD® 22.5 mg (3-monthly formulation) in controllingprostate specific antigen (PSA) and testosterone levels(ii) To assess health-related quality of life (HRQoL) through QoL questionnaires – European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-PR25) (prostate cancer disease specific patient reported outcome [PRO]) and EuroQol 5 Dimension 5 Level Health State Utility Index (EQ5D-5L) (generic PRO)

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2017-07-31 36 2020-07-31 2020-07-17

Completed

Institution Classification Region LTO #
Astellas Pharma Singapore Pte Ltd Private Business Singapore Not Applicable
Institution Classification Region LTO #
Quintiles Philippines, Inc. Private Business NCR CDRR-NCR-CRO-2
Institution Region
Astellas Pharma Singapore Pte Ltd Singapore
Name E-Mail Institution and Institution Address
Elena Lam QMNL.HealthRegistrymailbox@quintiles.com 41F Unionbank Plaza Bldg., Meralco Ave., cor. Onyx Road, Ortigas Center, Pasig City, 1600
Name E-Mail Institution and Institution Address
Elvira Lansang, MD elvira.lansang@astellas.com 6 Temasek Boulevard, #26-03/04/05 Suntec Tower Four Singapore 038986
Name Expertise Affiliation
Dennis Serrano, MD Urologist Manila Doctors Hospital
Jaime Songco, MD Urologist- Urologic Oncologist Makati Medical Center
Jason Letran, MD Urologist- Urologic Oncologist Cardinal Santos Medical Center
Project Location Institutional Ethics Review Board
Manila Doctors Hospital Manila Doctors Hospital Institutional Review Board
Makati Medical Center Makati Medical Center Institutional Review Board
Cardinal Santos Medical Center Cardinal Santos Medical Center Ethics Review Committee

Prostate Cancer

To establish the safety profile of ELIGARD® in ethnic Asian prostate cancer patients

Secondary Objectives:(i) To describe the efficacy of ELIGARD® 22.5 mg (3-monthly formulation) in controllingprostate specific antigen (PSA) and testosterone levels(ii) To assess health-related quality of life (HRQoL) through QoL questionnaires – European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-PR25) (prostate cancer disease specific patient reported outcome [PRO]) and EuroQol 5 Dimension 5 Level Health State Utility Index (EQ5D-5L) (generic PRO)

Completed

Clinical Trial

7015-MA-3072

20161117113711

2017-03-06

0000-00-00

53

17

Early completion of global study recruitment

31 Jul 2017

Inclusion:A patient for whom the physician has decided to initiate treatment with a Luteinizing Hormone Releasing Hormone (LHRH) agonist in standard clinical practice will be approached for enrolment into this study.1. Being ethnic Asian male patient above 18 years of age2. Being willing and able to provide written informed consent3. Biopsy-proven prostate adenocarcinoma4. Locally advanced prostate cancer with biochemical relapse following radical prostatectomy or radiotherapy. Biochemical relapse (1) is defined as:    PSA > 2 ng/mL following radiotherapy, or    Two consecutive PSA values > 0.2 ng/mL and rising above the nadir following radical prostatectomy5. 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.6. 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:1. Patient with castrate resistant prostate cancer (CRPC)2. Patient who previously underwent bilateral orchiectomy3. Patient who has received prior treatment with LHRH analogues4. Prior or concomitant treatment with systemic chemotherapy. A patient where there is a likelihood to receive systemic chemotherapy should not be enrolled5. Life expectancy of 1 year due to comorbdities6. Participation in another interventional clinical trial within one month prior to study entry or during the duration of the study7. Physician is planning to give the patient intermittent ADT at the time of study entry8. Patient receiving non-palliative radiotherapy within 3 months prior to study entry9. Patient receiving adjuvant ADT in combination with definitive radiotherapy10. Patient with metastatic hormonal treatment-naive prostate cancer, for whom chemo-hormonal treatment (combination of Docetaxel and ADT) is indicated.11. Patient with hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonist analogs or any of the components of ELIGARD®12. Patient with any contraindication for ELIGARD® use based on local prescribing information

Interventional

Unspecified

ELIGARD® 22.5 mg being administered at baseline, 3rd month, 6th month, 9th month, 12th month and 15th month.

Date Amendment Classification Reason
2018-11-16 Amendments related to the protocol
2018-11-16 Amendments related to the protocol
2018-11-16 Amendments related to the protocol
2018-11-16 Amendments related to the protocol

Unspecified

Unspecified

Unspecified

Unspecified

To establish the safety profile of ELIGARD® in ethnic Asian prostate cancer patients.

Phase IV

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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