Prostate Cancer Clinical Trial
Official title:
A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 (Zibotentan) 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients
Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan)
in hormone resistant prostate cancer (HRPC).
This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan)
can improve progression-free survival and overall survival against a background of existing
prostate cancer treatments.
ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and
spread by blocking Endothelin receptor activity. This trial will look at the effects of
ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising
PSA after surgical or medical castration but have no evidence of metastases.
All patients participating in this clinical trial will receive existing prostate cancer
treatments in addition to trial therapy.
Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive
placebo in addition to standard prostate cancer therapy. By participating in this trial
there is a 50% chance that patients will receive an agent that may slow the progression of
the tumour.
No patients will be deprived of standard prostate cancer therapy.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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