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

• Status: Completed
• Trial end date: 2019-11-19
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Singapore Pte. Ltd.
• Treatments: Leuprolide

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