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

Astellas

Status and phase: Completed; Phase 4

Conditions: Prostate Cancer

Treatments: Drug: Leuprolide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03035032

7015-MA-3072

Details and patient eligibility

About

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

Enrollment: 107 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

Leuprolide Acetate 22.5 milligrams (mg)

Experimental group

Description:

Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.

Treatment:

Drug: Leuprolide