Prostate Cancer Clinical Trial
Official title:
A Phase II Randomised Efficacy and Safety Study of Vandetanib (ZD 6474) in Combination With Bicalutamide Versus Bicalutamide Alone in Patients With Chemotherapy Naive Hormone Refractory Prostate Cancer.
Purpose To define the efficacy, tolerability and safety of Vandetanib in combination with
bicalutamide in patients with chemotherapy naive hormone refractory prostate cancer
Hypothesis There will be a PSA response when Vandetanib is given in combination with
Bicalutamide in Chemotherapy Naive Hormone refractory prostate cancer patients.
With the advent of PSA surveillance, many patients diagnosed with hormone refractory
disease, have PSA rising disease only, are asymptomatic, with no evidence of metastatic
disease. There is no standard of care in this patient population. A standard treatment in
this population has been the addition of a non-steroidal anti androgen such as bicalutamide.
PSA response rate (defined as a 50% decrease) have been reported in 20% range with
bicalutamide.
Even in patients with hormone refractory prostate cancer (HRPC) and metastases that have no
cancer related symptoms, initiation of chemotherapy is controversial given the palliative
nature of chemotherapy and potential for serious toxicity.
These patients are generally well enough to to undergo trials of novel agents and achieve
adequate drug exposure, such that any cytostatic effect will be apparent.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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