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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03035032
Recruitment Status : Active, not recruiting
First Posted : January 27, 2017
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Singapore Pte. Ltd. )

Brief Summary:
The objective of this study is to evaluate the safety, efficacy, and impact on quality of life (QoL) of ELIGARD® in hormone-dependent prostate cancer patients in Asia.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Leuprolide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV Interventional Safety Study of ELIGARD® in Prostate Cancer Patients in Asia (ELIGANT)
Actual Study Start Date : June 23, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Leuprolide group
Leuprolide will be administered for 18 months.
Drug: Leuprolide
Subcutaneous Injection
Other Names:
  • Leuprolide acetate
  • Eligard
  • Leuprorelin acetate




Primary Outcome Measures :
  1. Incidence of drug-related adverse events [ Time Frame: Up to Month 18 ]
    The safety analysis is based on the occurrence of ELIGARD related AEs and ELIGARD related SAEs, independent of investigator assessed causality, occurring during the study will be collected and summarized according to their severity and relationship to ELIGARD.


Secondary Outcome Measures :
  1. Percentage of participants with testosterone < 20 ng/dL [ Time Frame: Up to Month 18 ]
    Testosterone level will be assessed for all participants at each scheduled visit, prior to administering ELIGARD®, and at the follow-up visit.

  2. Percentage of participants with testosterone 20-50 ng/dL [ Time Frame: Up to Month 18 ]
    Testosterone level will be assessed for all participants at each scheduled visit, prior to administering ELIGARD®, and at the follow-up visit.

  3. Percentage of participants with testosterone > 50 ng/dL [ Time Frame: Up to Month 18 ]
    Testosterone level will be assessed for all participants at each scheduled visit, prior to administering ELIGARD®, and at the follow-up visit.

  4. Time to Prostate Specific Antigen (PSA) progression [ Time Frame: Up to Month 18 ]
    PSA progression as the date that a 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir is documented

  5. Change from baseline in quality of life assessed by EORTC QLQ-PR25 [ Time Frame: Baseline and up to Month 18 ]
    EORTC QLQ-PR25: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

  6. Change from baseline in quality of life assessed by EQ5D-5L [ Time Frame: Baseline and up to Month 18 ]
    EQ5D-5L: EuroQol 5 Dimension 5 Level Health State Utility Index



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035032


Locations
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Hong Kong
Site HK01001
Hong Kong, Hong Kong
Site HK01002
Hong Kong, Hong Kong
Indonesia
Site ID02001
Jakarta, DKI Jakarta, Indonesia
Malaysia
Site MY03002
Batu Caves, Selangor, Malaysia
Site MY03001
Kuala Lumpur, Malaysia
Philippines
Site PH04001
Makati City, Metro Manila, Philippines
Site PH04003
Manila, Metro Manila, Philippines
Site PH04002
San Juan, Metro Manila, Philippines
Singapore
Site SG05001
Singapore, Singapore
Site SG05002
Singapore, Singapore
Site SG05003
Singapore, Singapore
Taiwan
Site TW06001
Taichung, Taiwan
Site TW06002
Taichung, Taiwan
Site TW06003
Taipei, Taiwan
Thailand
Site TH07001
Muang, Chiang Mai, Thailand
Site TH07004
Hat Yai, Songkhla, Thailand
Site TH07003
Bangkok, Thailand
Vietnam
Site VN08001
Ho Chi Minh City, Vietnam
Site VN08002
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Astellas Pharma Singapore Pte. Ltd.
Investigators
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Study Director: Medical Director Astellas Pharma Inc

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Responsible Party: Astellas Pharma Singapore Pte. Ltd.
ClinicalTrials.gov Identifier: NCT03035032     History of Changes
Other Study ID Numbers: 7015-MA-3072
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Singapore Pte. Ltd. ):
Leuprolide acetate
Prostate cancer

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents