Conditions: Prostate Cancer
Keywords: rising PSA bone metastases Clinical study pain-free or mildly symptomatic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 447
Healthy volunteers: no

Brief summary:
This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).

Detailed description:

Arms:
arm 1: Matching placebo oral tablet once daily, with best supportive care arm 2: ZD4054 10 mg oral tablet once daily, with best supportive care arm 3: ZD4054 15 mg oral tablet once daily, with best supportive care

Interventions: intervention 1: ZD4054 15 mg intervention 2: Placebo intervention 3: ZD4054 10 mg
Intervention descriptions: intervention 1: 15 mg oral tablet once daily intervention 2: None intervention 3: 10mg oral tablet once daily

Protocol document: