Conditions: Prostate Cancer
Keywords: Hormone Resistant Prostate Cancer Endothelin A Receptor Antagonist Endothelin A Endothelin A antagonist
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 896
Healthy volunteers: no

Brief summary:
Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases.

* This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo.
* 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.
* All patients participating in this clinical trial will receive existing standard 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.

Detailed description:

Arms:
arm 1: ZD4054 10 mg oral tablet once daily arm 2: Matching Placebo, oral tablets once daily

Interventions: intervention 1: ZD4054 intervention 2: Placebo
Intervention descriptions: intervention 1: ZD4054 10 mg oral tablet once daily intervention 2: Matching placebo oral tablet once daily

Protocol document: