Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy

A Randomized, Double-blind, Multicentre, Phase II Controlled Trial Assessing ZACTIMATM (Vandetanib) Against Placebo in Prolonging the Off-treatment Interval in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy

The purpose of this study is to determine whether treatment with Zactima for up to 18 months will prolong the off-treatment interval in patients who are undergoing intermittent androgen deprivation therapy.

Inclusion Criteria:

• Diagnosis of prostate cancer
• Prostate specific antigen (PSA) greater than or equal to 5 ng/mL
• Recent completion of first hormone treatment [intermittent androgen deprivation with a Luteinising hormone releasing hormone (LHRH) analogue]
• Screening PSA ≤1.0 ng/mL (within 6 weeks prior to study Day1)

Exclusion Criteria:

• Bone or soft tissue metastases
• Significant cardiovascular disease including hypertension not controlled by medical therapy or history of irregular heart beats or recent heart attack