A Phase III Trial to Test the Efficacy of ZD4054(Zibotentan), an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.

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.

Enthuse M1是一项针对激素抵抗型前列腺癌伴骨转移患者的大型III期临床试验，旨在评估ZD4054（Zibotentan）的安全性与有效性。
- 本临床试验将验证内皮素A受体拮抗剂ZD4054（Zibotentan）对比安慰剂能否改善患者生存结局。
- ZD4054（Zibotentan）属于新型抗肿瘤制剂，通过阻断内皮素A受体活性以延缓肿瘤生长与转移，本试验将探究其在激素抵抗型前列腺癌伴骨转移患者中的治疗效果。
- 所有参与本临床试验的患者，除接受试验治疗外，还将接受现行标准前列腺癌治疗方案。
- 半数患者将在标准前列腺癌治疗基础上联合ZD4054（Zibotentan），另一半患者则联合安慰剂；参与本试验的患者有50%概率获得可延缓肿瘤进展的新型制剂。
- 所有患者均不会被剥夺标准前列腺癌治疗的相关权益。