Conditions: Prostate Cancer
Keywords: Hormone Resistant Prostate Cancer Endothelin A Receptor Antagonist Endothelin A Endothelin A antagonist
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1494
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks arm 2: ZD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks

Interventions: intervention 1: Docetaxel intervention 2: ZD4054 intervention 3: Placebo
Intervention descriptions: intervention 1: intravenous infusion given every three weeks intervention 2: 10 mg oral once daily dose intervention 3: placebo oral tablet once daily

Protocol document: