Conditions: Prostate Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 95
Healthy volunteers: no

Brief summary:
This randomized, double-blind phase II trial is to assess the efficacy and safety of bicalutamide (Casodex® ) associated to ZD6474 (Zactima™ ) or to placebo in patients with castration-refractory metastatic prostate cancer without any clinical symptom related to disease progression. The study is blinded, and subjects will be randomised (1:1 ratio) to either ZD6474 300 mg or placebo. The blinded design ensures robust, unbiased data collection and assessment. Placebo control is necessary to ensure a robust assessment of PSA PFS, and is acceptable in this subject population where all subjects will also received bicalutamide 150 mg o.d. Subjects will continue study treatment until they reach objective biological disease progression or unacceptable toxicity or withdrawal of consent or until end of trial (which event occurs first). The end of study is fixed 12 months after the last randomised patient's first dose of study treatment.

Detailed description:

Arms:
arm 1: Bicalutamide 150mg + ZD6474 300mg arm 2: Bicalutamide 150mg + placebo

Interventions: intervention 1: ZD6474 (Vandetanib) intervention 2: Bicalutamide intervention 3: Placebo
Intervention descriptions: intervention 1: 300mg orally, once daily intervention 2: 150mg orally, once daily intervention 3: orally, once daily

Protocol document: