Prostate Cancer Clinical Trial
Official title:
A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer
Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054
(Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone
resistant prostate cancer (HRPC).
This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan)
can further improve survival compared with docetaxel alone.
ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and
spread by blocking Endothelin A receptor activity. This trial will look at the effects of
ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases
compared with docetaxel.
All patients participating in this clinical trial will receive docetaxel chemotherapy, which
is a commonly used chemotherapy to treat prostate cancer in addition to other existing
prostate cancer therapies.
Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive
placebo in addition to docetaxel and other prostate cancer therapy. By participating in this
trial there is a 50% chance that patients will receive an agent that may further 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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