Phase IIIb, Open-label, randomized, controlled multi-centre study. Induction therapy phase for 6 months where all subjects receive 2 ELIGARD depot injections. Those subjects with hormone responsive prostate cancer will be randomized and will receive either intermittent or continuous ELIGARD treatment for 36 months. Following this treatment period, subjects will enter a long-term follow-up period for 48 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
706
LHRH antagonist
Time to PSA progression
Time frame: 3 Years
Overall survival
Time frame: 5 Years
World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status
Time frame: 3 Years
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and QLQ-PR25
Time frame: 3 Years
Time to serum testosterone > 50 ng/dL
Time frame: 3 Years
Change in progression biomarkers (some sites)
Time frame: 3 Years
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Unnamed facility
Brussels, Belgium
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Brussels, Belgium
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Brussels, Belgium
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Leuven, Belgium
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Liège, Belgium
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Bmo, Czechia
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Jablonec nad Nisou, Czechia
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Olomouc, Czechia
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Ústí nad Labem, Czechia
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Joensuu, Finland
...and 61 more locations