A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer
This is a phase II study of a GnRH antagonist drug, Degarelix, for use in hormone resistant
prostate cancer patients who have had biochemical PSA progression despite the use of total
androgen blockade therapy. Patients will receive at least six monthly injections of
Degarelix unless the patient shows radiographic or symptomatic disease progression,
intolerable toxicity or decides to withdraw from the study. Patients will be evaluated for
measures of efficacy, toxicity and disease progression during treatment and afterwards until
radiologically confirmed metastatic disease progression or until the patient is removed from
the study.
Overall objective:
The efficacy of Degarelix as a treatment for HRPC will be evaluated
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA Progression
Canada: Health Canada
DEGHRPCa-001
NCT01545882
May 2011
May 2012
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