Dataset from A Randomized, Double-blind Phase II Trial 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

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.